19 December 2016
The second workshop of our "Quality & Metrics working group, founded within the ISPE Turkey Affiliate in 2016 and leaded by İlknur Gümüşeli Hırçın, was held in December 19, 2016 at Topkapı facility of Bayer Turkey.
Following the opening remarks of ISPE Turkey Affiliate Chair Fatma Taman and Board Member İlknur Gümüşeli Hırçın, Havva Çınar Aşar's presentation focused on quality metrics pilot programs and expectations of FDA and MHRA regarding quality metrics.
The highly attended workshop was concluded with the interactive evaluation of the views of participants to determine the issues to be discussed in future meetings.
Within the scope of the seminars organized by Istanbul Universitys ISPE Student Chapter with the aim of introducing various working areas in the pharmaceutical industry to the Students of the Pharmaceutical Faculty, our Board Member Hülya Uslu gave a Quality Assurance themed seminar on 2 December, 2016.
Quality & Metrics 2nd Workshop
19 December 2016
The second workshop of our "Quality & Metrics working group, founded within the ISPE Turkey Affiliate in 2016 and leaded by İlknur Gümüşeli Hırçın, will be held in December 19, 2016 at Topkapı facility of Bayer Turkey.
Within the scope of the workshop, our Board Member Havva Çınar Aşar's presentation will focus on quality metrics pilot programs and the expectations of FDA and MHRA regarding quality metrics. In addition, the topics to be discussed at future workshops will be assessed based on the evaluations of the participants.
We hope to be together at our interactive event.
Note: ISPE Membership is a pre-requisite for participation to the workshop.
25 November 2016
ISPE Turkey Affiliates 2016 Fall Seminar was held on 25 November 2016 at Barbaros Point Hotel Istanbul with the theme of A Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0.
The seminar started with opening remarks of Fatma Taman, Chair of ISPE Turkey Affiliate, and continued with "GMP Updates in the PIC/S Compliance Process" presentation of MSc. Pharm. Gülşen Yılmaz from the Inspection Vice Presidency of Turkish Medicines and Medical Devices Agency (TMMDA) who elaborated on TMMDAs studies with regards to PIC/S membership application process.
Siemens Digital Factory Country Division Lead Ali Rıza Ersoy presented the concept of Industry 4.0 which was very well received by the audiance and Nejat Babür, Anel Group Mechanical Design Coordinator, shared his experience and knowledge via his presentation on the facilities of the future and new approaches for facility design.
The afternoon session of the seminar included Ecolab Life Sciences Unit Middle East Africa Manager Burcu Şekers presentation about Cleaning and Contamination Control in the Facilities of Future and Deloitte Health and Pharmaceutical Industry Leader Güler Hülya Yılmazs presentation on Health and Pharmaceutical Sector Predictions for the year of 2020.
The seminar was concluded with an interactive panel session where sectoral topics like biotechnology, PIC/S process, R&D studies were discussed with the contributions of Chair of Pharmaceutical Industry Association of Turkey (TISD) Cengiz Celayir, Secretary General of Pharmaceutical Manufacturers Association of Turkey (İEİS) Turgut Tokgöz and Secretary General of Association of Research-Based Pharmaceutical Companies (AİFD) Dr. Ümit Dereli.
Chair of ISPE Turkey Affiliate Fatma Tamans article titled as Operational Excellence from ISPEs Perspective has been published in the 50th Special Issue of the Workshop Magazine.
Fatma Taman emphasized that operational excellence is a roof concept that aims doing more with less, taking into account all operational processes and integrating values including health and safety, environment and quality. From the perspective of the pharmaceutical industry which is based on advanced technology that needs to adapt scientific and technological developments rapidly, but on the other hand, can not compromise in quality, coupled with the fact that saving policies in pharmaceutical spending are an important matter in the agenda of public authorities, Ms. Taman pointed out that the improvements in the pharmaceutical sector are even more sensitive and important.
Fatma Taman referred to ISPE Turkey Affiliates seminars organized in order to enable the Turkish pharmaceutical industry to closely monitor the changes in the global platform via worldwide experts that contribute as speakers; also mentioned PAT (Process Analytical Technologies) working group which deals with the QbD (Quality by Design) topic that has a wide range of potential applications in the pharmaceutical industry and the PQLI (Product Quality Life Cycle Application) approach that aims to integrate quality into the whole lifecycle of the product and emphasized the great importance of all these activities in the context of Operational Excellence.
It was indicated that the topic of Operational Excellence will be discussed in the future Industry Gatherings planned by ISPE Turkey Affiliate as afternoon meetings which are enriched by experience sharing of speakers coming from different sectors, after having discussed current topics such as Data Integrity and Industry 4.0 so far. Further studies are also planned to be continued within the Excellence in Pharma Engineering Working Group which will be founded in 2017.
A Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0
25 November 2016
ISPE Turkey Affiliates 2016 Fall Seminar will be held on 25 November 2016 at Barbaros Point Hotel Istanbul around the theme of Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0.
The concept of Industry 4.0 and 2020 predictions for the Health-Pharmaceutical Sector will be presented. Design and Contamination Approaches for Pharmaceutical and Biotechnological Facilities of the Future will also be discussed in conjunction with these developments.
Some of the speakers:
We hope for your participation to this important seminar focused on creating the vision for the future.
The detailed program (in Turkish) will be presented later.
Third International Congress for Plastic Packaging Technologies was organized a day before Eurasia Packaging Fair, on 1st of November 2016 in Istanbul by PAGEV (Turkish Plastic Industry Foundation).
At this year's congress created with the supports of ISPE Turkey Affiliate, plastic packaging used in the pharmaceutical and cosmetic sectors was taken under the spotlight in conjunction with the congress theme of Innovative Packaging Trends and Branding. As a speaker, Our General Secretary Buket Hekiman Bayraktar has contributed to the pharmaceutical panel of the congress where topics such as new technologies, innovative developments, sustainability, design and branding were discussed.
The 1st International JFDA Congress, hosted by the Jordanian Health Authority was held in Amman - Jordan on October 27-28, 2016 around the theme of "Opportunities and Future Vision for Pharmaceutical Sector. Including Dr. Hakkı Gürsöz, the President of Turkish Medicines and Medical Devices Agency (TMMDA) and Dr. Ali Alkan, TMMDA Vice Presidency of Medicines and Pharmacy, high-order bureaucrats and health authority executives from neighboring countries have extensively participated to the congress, where Chair of ISPE Turkey Affiliate Fatma Taman had a presentation on "Risk Mitigation for Sterile Pharmaceutical Products".
18 October 2016
The second of Industry Gatherings that ISPE Turkey Affiliate organizes as afternoon meetings based on the current issues, was held on 18 October 2016 at The Grand Tarabya and covered the topic of Industry 4.0.
Following opening remarks of our Chair Fatma Taman, Tolga Avşar - General Manager of Scheer Turkey presented the expected changes for business life in the near future with an emphasis on the upcoming 4th industrial revolution called "Industry 4.0". The meeting continued with the speech of Ali Rıza Ersoy - Digital Factory Division Director of Siemens and he elaborated on the Industry 4.0 concept based on his knowledge and experiences that were well received by the audience.
We thank all participants and wish to meet in future Industry Gatherings which are aimed at addressing various current issues concerning the pharmaceutical industry.
The second workshop of Data Integrity Key for GMP Compliance working group founded in 2016 within the ISPE Turkey Affiliate was held on October 14, 2016 at the facilities of Nobel İlaç Tic. ve San. A.Ş. Ümraniye with broad participation from the pharmaceutical industry.
The workshop started with opening remarks of Hakan Şahin, General Manager of Nobel Pharmaceuticals, and the presentations of Our Chair Fatma Taman and Ulkar Holdings Corporate Quality Manager Aysel Köker; then continued with our working group leader Figen Ergins presentation about Authority warning letters in connection with data integrity issues and group studies under the topics of quality control, quality assurance, production / storage and validation were performed as preliminary work towards a risk inventory.
We thank Nobel Pharmaceuticals and all our participants for their contributions and wish to meet in future workshops and seminars.
Industry Gathering: Industry 4.0
18 October 2016
The second of Industry Gatherings that ISPE Turkey Affiliate organizes as afternoon meetings based on the current issues, will be held on 18 October 2016 at The Grand Tarabya and will cover the topic of Industry 4.0.
We wish to be together at our meeting which will provide a knowledge sharing platform for "Industry 4.0" concept based on the presentations of our esteemed speakers, Tolga Avsar - General Manager of Scheer Turkey and Ali Rıza Ersoy - Deputy General Manager for Digital Factory Division of Siemens.
Date: October 18, 2016 - Tuesday
Location: The Grand Tarabya - Tarabya Hall
The premier pharmaceutical manufacturing event of the year, ISPE Annual Meeting was held on 18-21 September 2016 in Atlanta, USA. The Turkey Affiliate was represented by our Chair Fatma Taman, Affiliates Secretary General Buket Hekiman Bayraktar and Reserved Member of the Board Banu Refik. In the awards ceremony on September 20, our Affiliate was honoured by receiving the "Affiliate of the Year Award for the service to membership and innovative contributions towards the development of the pharmaceutical industry.
The award given by Joseph Famulare, the Chairman of ISPE International Board for 2015-2016 and Michael Arnold the Chairman for 2016-2017 was received by our Chair Fatma Taman on behalf of our Affiliate, which recently celebrated its 10th year anniversary in 2015. Fatma Taman expressed our pride for getting this award for the second time after the first Affiliate of the Year Award that we got in 2007, only 2 years after the foundation of our Affiliate.
This important recognition achieved one more time should enhance Turkey's credibility in the global pharmaceutical platform. We are grateful to our Board and all our members for their individual contributions toward this success.
October 14, 2016
The second workshop of ISPE Turkey Data Integrity Key for GMP Compliance working group will be held on October 14, 2016 at the facilities of Nobel İlaç Tic. ve San. A.Ş. Ümraniye.
We wish to be together at our workshop where group studies about the risk inventory and authority warning letters with regards to data integrity matters will be conducted.
CPhI Istanbul and its co-located events that gathered regional drug manufacturers, suppliers, solution and technology providers was held on 1 - 3 June 2016 at Istanbul Congress Center, ICC, Turkey.
The visitors were informed about the objectives, working groups and events of ISPE Turkey Affiliate via the booth that was set up at the exhibition which gathered participants from abroad, science and technology experts, government delegates and major players of the pharmaceutical sector.
The General Assembly of ISPE Turkey Affiliate was held on 4 May 2016. Following the presentation of the annual report for 2014-2015, financial statements and report of the supervisory board; the estimated budget for 2016 was conferred.
The new Board, as decided to consist of 14 people , was elected for 2 years of tenure: Fatma Taman (PharmaVision), Sabiha Buket Hekiman Bayraktar (PharmaVision), Sabine İlknur Gümüşeli Hırçın (Bayer), Havva Çınar Aşar (Bayer), Neşe Buket Aksu (İstanbul Kemerburgaz University), Ayla Deliorman (Santa Farma) and Devrim Çavuşoğlu (Pfizer) were elected as Principal Members and Fahrettin Kazak (PharmaVision), Tanju Cepheli (BASF), Zafer Öztuncer (Merck), Figen Ergin (BTS), Hülya Uslu, Yıldız Özsoy Erginer (İstanbul University), Banu Refik (Conval Group) were elected as Reserved Members.
We welcome the members of Board and wish to leave our mark on further achievements together.
ISPE International Board!
24-25 October 2016, Industriepark Höchst, Frankfurt, Germany
ISPE Europe Conference on Biotechnology will be held on 24-25 October 2016 at the Sanofi plant in Frankfurt, Germany.
The conference which promises collaborative networking with the best industry professionals through case studies, presentations, panel discussion and the opportunity to participate in a Sanofi Plant Tour will focus on revisiting the bio-manufacturing approach and perspective through the core areas of Regulatory and Quality, Knowledge Management, Process Science, Technology and Innovation.
For more information and registration: http://www.ispe.org/2016-europe-biotechnology-conference
Data Integrity Key for GMP Compliance Workshop
26 May 2016
The first workshop of our "Data Integrity Key for GMP Compliance" working group founded in 2016 within the ISPE Turkey Affiliate, was held in May 26, 2016 at Gebze 1 facility of Sandoz.
Following opening remarks of Sandoz Gebze 1 Site Lead Şafak Öner and our Chair Fatma Taman; general titles referred at Data Integrity Industry Gathering that was held on March 21, 2016 at The Grand Tarabya were discussed in details; several FDA warning letters were reviewed via the interactive presentations of Figen Ergin, the leader of our working group.
Gülbengü Kuzgun Yüksel, Quality Unit Manager of Sandoz Gebze 1 gave substantial information via the presentation where she shared her experiences on data integrity based on the studies conducted on their site.
We hope to be together at our events that will be held on the continuation of the highly productive workshop where sectoral discussions were made on "Data Integrity" topic with the contributions of all participants.
CPhI Istanbul and its co-located events which will gather regional drug manufacturers, suppliers, solution and technology providers during 3 days will be held on 1 - 3 June 2016 at Istanbul Congress Center, ICC, Turkey.
You are invited to ISPE Turkey Affiliate booth on the B5 floor of the exhibition that will bring together science and technology experts, government delegates and major players of the pharmaceutical sector (Booth no:F39D).
For more information about the exhibition and conference: www.cphi-istanbul.com
Data Integrity Key for GMP Compliance Workshop
26 May 2016
The first workshop of our "Data Integrity Key for GMP Compliance" working group, founded in 2016 within the ISPE Turkey Affiliate, will be held in May 26, 2016 at Gebze 1 facility of Sandoz.
General titles referred at Data Integrity Industry Gathering that was held on March 21, 2016 at The Grand Tarabya, will be discussed in details; several FDA warning letters will be reviewed and delegates from Sandoz will elaborate on data integrity studies conducted on the site.
We wish to be together at our workshop where Data Integrity topics will be evaluated on a sectoral basis.
The first workshop of our "Quality & Metrics working group, founded within the ISPE Turkey Affiliate in 2016 and leaded by İlknur Gümüşeli Hırçın, was held in May 4, 2016 at Topkapı facility of Bayer Turkey.
Following the General Assembly of ISPE Turkey Affiliate, the workshop was initiated with opening remarks of our Chair Fatma Taman and Board Member İlknur Gümüşeli Hırçın. Discussions around "Quality Metrics" concept, practices and challenges in this regard were covered via the detailed Requirements and Assessment of Quality Metrics presentation of our Board Member Havva Çınar Aşar.
We hope to be together in workshops and seminars that will be planned as sequels of our interactive workshop where sectoral discussions and assessments were made on "Quality Metrics" studies.
ISPE Turkey Affiliate's Spring Seminar on Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals" was held on 15 April 2016, at Barbaros Point Hotel, Istanbul.
The seminar which brought together participants from various areas such as pharmaceutical industry, suppliers, and academy, opening remarks of our Chair Fatma Taman were followed by ISPE's Vice President for European Operations Dr. Thomas Zimmers presentation on the ongoing studies for ensuring the continuity of drug supply.
GDP implementations for pharmaceutical and biological products were explained by Khalid Alfhaid, International Quality Senior Manager from Amgen and real-life examples on GDPs were presented by Zafer Öztuncer, Intercontinental Quality Assurance Director from Merck Pharmaceuticals.
On the afternoon session of the seminar, Jean-Marie Higel, Head of Service Quality in Global Services at BASF presented Good Distribution Practices for APIs and Deva Holding Logistics Manager Gürcan Coşgun elaborated on the transportation requirements in the scope of GDP. The seminar was concluded with an interactive panel session where GDP topics were discussed at a wide range with the contributions of the speakers and participants.
Our Affiliate Chair Ms. Fatma Taman made a presentation with the title of "ISPE Turkeys Perspective on Evolving Regulations and Facilities of the Future on Thursday, April 21, 2016 at Cleanroom Technology, Maintenance and Equipment Exhibition organized on 21-23 April 2016 in ICEC Lütfi Kırdar International Congress and Exhibition Center, İstanbul.
Following a quick overview of ISPE Turkey Affiliates recent accomplishments, hot topics that will soon impact the pharmaceutical industry both on a national and international level such as Industry 4.0, GMP revisions, future-proof facilities were covered and were followed with great interest by the representatives of health, medicine and chemical sectors as well as pharmaceutical and biotechnology industry experts.
The visitors were informed about the objectives, training programs, working groups and global events of ISPE Turkey Affiliate via the booth that was set up at the exhibition which gathered cleanroom specialists and managers, laboratory assistants, facilities and process managers, maintenance engineers, quality control experts and R&D managers.
For more information about the exhibition: http://www.expocleanroom.com/default.asp
Quality & Metrics Workshop
May 4, 2016
The first workshop of our "Quality & Metrics working group, founded in 2016 within the ISPE Turkey Affiliate, will be held in May 4, 2016 at Topkapı facility of Bayer Türk.
The workshop will begin following the General Assembly of ISPE Turkey Affiliate and will cover discussions around "Quality Metrics" concept, practices and challenges in this regard.
We wish to be together at our workshop where studies on "Quality Metrics" will be assessed and evaluated on a sectoral basis.
Good Distribution Practices for APIs,
Pharmaceuticals and Biopharmaceuticals
15 April 2016
ISPE Turkey Affiliate's Spring Seminar on Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals" will be held on 15 April 2016, at Barbaros Point Hotel, Istanbul.
Studies for ensuring the continuity of drug supply will be presented by ISPE's Vice President for European Operations Dr. Thomas Zimmer, GDP applications for pharmaceutical and biological products will be explained by International Quality Senior Manager Khalid Alfhaid from Amgen Inc. and Intercontinental Quality Assurance Director Zafer Öztuncer from Merck Pharmaceuticals will relay information about cold chain practices for pharmaceutical and biopharmaceutical products. Following the presentation on GDP practices for APIs by Jean-Marie Higel, Head of Service Quality in Global Services at BASF; Deva Holding Logistics Manager Gürcan Coşgun will elaborate on the transportation requirements in the scope of GDP.
We look forward to your attendance to this important seminar which will cover the regulations about the storage and distribution practices for active ingredients, pharmaceuticals and biopharmaceuticals.
Participation Fee: For Members: 900 TL, For Non-Members: 1500 TL
Deadline for registration: 8 April 2016
Fatma Taman, Chair of ISPE Turkey Affiliate, and Buket Hekiman Bayraktar, General Secretary of ISPE Turkey Affiliate, met with future pharmacists in Career Days event of Istanbul Kemerburgaz University. During the visit on March 30th 2016, they contributed to shape future careers of pharmacist candidates by providing information about the working areas of pharmacists through the presentation titled as "Pharmacists in the Pharmaceutical Industry". Students were also guided to access current information for the pharmaceutical industry via ISPEs knowledge resources.
ISPEs Continuous Manufacturing Conference will take place on 20 21 April in Baltimore, Maryland USA. The conference will focus exclusively on Continuous Manufacturing an increasingly popular production strategy with numerous benefits, but also many challenges.
ISPE Turkeys industry gathering around the topic of Data Integrity that was held at The Grand Tarabya on 21 March 2016 was initiated by an introduction of industry gathering series by the Affiliates Chair Fatma Taman. The meeting turned out to be a very interactive one with everyones contributions, following the presentations of Figen Ergin (BTS Information Services) and Timur Kabadayı (Conval Group). The group decided to take the collaborative work further at future workshop platforms.
Industry Gatherings: Data Integrity
21 March 2016
As of 2016, ISPE Turkey Affiliate wish to gather the representatives of our sector in the afternoon meetings that will be organized around the current issues important for our industry.
The first one of our activities in the scope of those Industry Gatherings will be held on March 21, 2016 and will cover the topic of "Data Integrity" which currently has an increasing effect for all of us.
Date: March 21, 2016 - Monday
Time: 17:30 - 19:30
Location: The Grand Tarabya - Rumeli & Hisar Hall
Detailed information regarding the accomplishments and future goals of ISPE Turkey Affiliate can be found in the 10th anniversary video. Click here to see the video.
On the occasion of 10th Anniversary of ISPE Turkey Affiliate, our Chair Fatma Taman attended the live broadcast of Bloomberg HT news bulletin on February 24, 2016. The broadcast can be seen from here.
The news about our seminar "A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and 10th Anniversary Celebration that were organized on the 3th of December, 2015 at Four Seasons Hotel, Istanbul-Sultanahmet with the attandance of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials was published in the January-February 2016 issue of OTC News magazine.
Once again we thank all of our participants who were together with us on this important day and we would like to express our wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders.
The 2016 ISPE Europe Annual Conference Integrated Technology, Quality and Compliance Strategy for Effective Operations will bring together pharmaceutical, regulatory and technology experts from around the world in Frankfurt in 7-9 March 2016.
The conference will be initiated with executive speeches around the topics of operational excellence, continuous manufacturing and new regulations for pharmaceuticals and biopharmaceuticals and will continue with paralel tracks including GMP updates, facilities of the future, data integrity, risk management and innovative approaches for technical matters.
This two-and-a-half-day, must-attend, education conference will use best practice case studies to explore current technologies, regulatory requirements and will provide delegates with techniques for the evaluation and implementation of cutting-edge technologies. The Conference is aimed at Pharma Development Experts, Quality Management, Quality Assurance, Quality Operations, Quality Control, Quality Systems, Production & Distribution Personnel, Professionals Involved in Manufacturing, Development and Technology Transfer as well as Suppliers and Regulators with interest in new solutions and experiences.
Details about the conference and registration form can be found in the following link: www.ISPE.org/2016-Europe-Annual-Conference
Through the Tulak Tacloban project that ISPE Philippines had supported and ISPE Turkey Affiliate had also contributed after the Typhoon Haiyan hit the Philippines in 2013, 130 schoolchildren finished primary/elementary schooling at mobile schools and these same children are now volunteers in their own community for calamity awareness.
Seminar and 10th Anniversary Celebration / 03 December 2015
ISPE Turkey Affiliates seminar around the theme of A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and the cocktail was held on December 3, 2015 at Four Seasons Hotel Sultanahmet, İstanbul with the participation of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials.
The presentations about Harmonization in GMPs, EU and PIC/S GMP Recent Changes were made by Dr. Vee Revithi, Turkish Medicines and Medical Devices Agency PIC/S Processes by Pharm. Gülşen Yılmaz, Management of Generation Conflicts by Dr. Buket Aksu. Fatma Taman/ Chair of ISPE Turkey Affiliate, Dr. Ünsal Hekiman/ Founder and Honorary Chairman of ISPE Turkey Affiliate, Prof. Dr. Ahmet Araman/ Past Chair of Turkey Affiliate and Dr. Theodora Kourti/ ISPE Senior Vice President for Regulatory Affairs held a speech about the ISPEs activities with regards to the 10th Anniversary of the Affiliate.
While the Affiliates achievements for the past 10 years and the targets for the future were presented through the introductory video; it was also announced that grants to support education set in the name of late Board Member Zehra Gürol will be spread out with the contributions of the Affiliates gold sponspors.
Following the presentation of plaques to our event sponsor BTS and Founder Board Members, our 10th Anniversary was celebrated by cutting the 10th year cake all together and enjoying the cocktail reception with live classical music with the participation of all our guests.
We wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders...
Ms. Fatma Taman has been elected as Vice Chair for ISPEs European Affiliates Council for the term of 2015-2016, along with her Chair tenure at our Affiliate. Ms. Taman and our Secretary General Buket Hekiman Bayraktar took part at the ISPE Euroforum meeting, held in Munich on December 1 and contributed to the planning of ISPEs future European projects.
Our Chair Ms. Fatma Taman contributed to the ISPE Annual Meeting held on 8-11 November 2015 in Philadelphia-USA, with two presentations around the topics of GMP in Aging Facilities and Implementation of Pharmaceutical Track & Trace System. Ms. Figen Ergin (BTS) elaborated on quality management during the GMP in Aging Facilities presentation, while Mr. Timur Kabadayı (Conval) provided technical details for the validation aspect of Track & Trace Systems.
In addition, Our Chair Ms. Fatma Taman and our Secretary General Ms. Buket Hekiman Bayraktar took part at the Joint Affiliate Council Meeting, on behalf of our Affiliate.
Recent Developments in Quality by Design for Pharmaceutical Products
ISPE Turkey Affiliates 2015 Fall Seminar around the theme of Recent Developments in Quality by Design for Pharmaceutical Products was held on October 15, 2015 at Point Hotel Barbaros, İstanbul. The seminar included presentations and case studies about the QbD impact on product develeopment, defining the quality target product profile, preparation for the regulatory submission, the dissolution test and clinically relevant spesifications as well as risk based approaches in the pharmaceutical development.
The speakers Dr. Paul Dickinson , Dr. Marcel de Matas and Dr. Buket Aksu held their presentations in an interactive workshop setting, which was very well received by the audience.
A Holistic Look at Pharmaceutical Industry
on the 10th Anniversary of ISPE Turkey
03 December 2015
ISPE Turkey Affiliates seminar around the theme of A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey", and the cocktail for 10th anniversary celebration, will be held on December 3, 2015 at Four Seasons Hotel Sultanahmet, İstanbul.
The presentations will be around the topics of; Pharmaceutical Technology, Harmonization in GMPs, EU and PIC/S GMP Recent Changes, Turkish Medicines and Medical Devices Agency PIC/S Processes and Conflict in Generations.
All attendees are invited to enjoy the cocktail following the program and we look forward to your presence in this important event.
Please contact us for registration: firstname.lastname@example.org
Recent Developments in Quality by Design for Pharmaceutical Products
15 October 2015
ISPE Turkey Affiliates 2015 Fall Seminar around the theme of Recent Developments in Quality by Design for Pharmaceutical Products will be held on October 15, 2015 at Point Hotel Barbaros, İstanbul.
The seminar will include presentations and case studies applying advanced science and risk based approaches in pharmaceutical development. The process to define the quality target product profile and patient centric product design will be presented by Dr. Marcel de Matas, specifications in QbD development including clinically relevant specifications will be presented by Dr. Paul Dickinson and product/process design and understanding will be presented by Dr. Buket Aksu in an interactive workshop setting.
We look forward to your presence in this important seminar which will highlight the recent developments in QbD for pharmaceutical products.
Deadline for registration: 30 September 2015
Improving the Quality of Vocational Education and Training in Chemical Industry
"Improving the Quality of Vocational Education and Training in Chemical Industry" (CHEM-VET) project was implemented within the scope of Improving vocational and technical education in Turkey (IQVET) grant program, under the umbrella of Ministry of Labour and Social Security, conducted by Human Resources Development Program Authority and financed by the European Union and the Republic of Turkey.
During the revision process of Professional Standards coordinated by KIPLAS within the scope of this project, below mentioned documents were revised, corrected and ammended as necessary by ISPE and PharmaVision:
ISPE and PharmaVision delegates participated to the project closing conference on August 31, 2015, at the Mercure Istanbul Altunizade Hotel.
Drug Shortages Prevention Plan was developed by ISPE and its expert pharmaceutical and biopharmaceutical industry members and describes how industry can best prevent drug shortages from occurring by discovering root causes and through creating and sustaining organizational cultures supported by leadership, business processes and quality systems.
The ISPE Drug Shortages Prevention Plan is based upon ISPEs groundbreaking 2013 ISPE Drug Shortages Survey, which provided clear evidence that mitigating shortages requires a holistic approach and careful alignment of organizational aspects people as well as technical aspects of process and production.
ISPE Turkey Affiliates Seminar around the theme From Biotechnology to Social Media, Pharmacovigilance Practices on a Broad Spectrum took place on 08 June 2015 at Point Hotel Barbaros, Istanbul.
During the opening speech of Fatma Taman, Chair of ISPE Turkey Affiliate, Prof. Dr. Ahmet Araman was recognized for his valuable contributions to the Affiliate and a moment of silence was held for Zehra Gürol, departed member of the Affiliates Board.
Prof. Dr. Semra Şardaş from Toxicology Department of Marmara Universitys Faculty of Pharmacy held a speech on the history of pharmacovigilance and continued her presentation around the topic of the safety of biological products. Pharmacovigilance practices for biotechnological medicinal products and biosimilars were presented by Dr. Devrim Satık, Head of community of practice for biotechnological medicines and biosimilars at AİFD (Association of Research-Based Pharmaceutical Companies, in Turkey). Following the presentation about pharmacovigilance in practice held by Rabia Ayşe Çetin, Director for Pharmacovigilance at Delta PV, Dr. Eren Özçağlı from the Toxicology Department of Istanbul Universitys Faculty of Pharmacy elaborated on the usage of social media for pharmacovigilance. Finally Gürkan Budak, Application Manager at BTS made a demonstration about the management of pharmacovigilance requirements with electronic systems.
Motivated to enhance the activities of the Affiliate on its 10th year anniversary, the new Board has taken over by the General Assembly held after the lunch break of the Seminar.
In the QbD & PAT* Workshop which took place on 26 May 2015 at Bayer Türk, presentations about QbD Applications on Solid Dosage Forms were held by Prof. Dr. Yıldız Özsoy Erginer (Istanbul University, Faculty of Pharmacy, Pharmaceutical Technology Department), Gizem Yeğen (Pharmaceutical Engineering , Istanbul University Health Sciences Institute) and Önder Demir (Pharmaceutical Engineering , Istanbul University Health Sciences Institute). Presentations which included Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) of tablet dosage forms, Artificial Intelligence Programs and several case studies were very well received by the audience.
* QbD: Quality by Design; PAT: Process Analytical Technologies
The 2015 ISPE Europe Annual Conference was held on 4 - 7 May in Frankfurt. Presentations and discussions around the topics like political and economic situation of the pharmaceutical industry in Europe, benchmarking for implementations of Regulatory Authorities, integrated quality and production systems, facilities of the future, innovation for effective business solutions and regulatory compliance and drug shortages in Europe and beyond were very well received by the audience.
Ms. Fatma Taman, Chair of ISPE Turkey Affiliate, held a presentation about Mass Serialization and Track & Trace Applications in Turkey and elaborated on the transition process and issues to be considered during the implementation of the 2D system. On the other hand, Ms. Buket Hekiman, General Secretary of ISPE Turkey Affiliate, was the emcee for ISPEs presentation explaining membership benefits for non-member conference attendees.
ISPE Turkey Student Chapter held a Career Day Event on 2 May 2015 with the participation of 120 students from Pharmacy Faculties of Istanbul University, Marmara University, Yeni Yüzyıl University, Medipol University, Yeditepe University, Bezmialem University, Hacettepe University and Anadolu University. Following the opening speech of Prof. Dr. Ahmet Araman, Dean of Istanbul University Faculty of Pharmacy, managers from various pharmaceutical companies such as Sandoz, Santa Farma, Abbott and Abbvie elaborated on their personel experience in the industry and presented career opportunities in their respective companies to the students.
Representing the pharmaceutical industry, ISPE Turkey Affiliate has participated to the workshop organized by KIPLAS (The Chemicals, Petroleum, Rubber and Plastics Industry Employers Association of Turkey) for the review of Professional Standards on March 4-6, 2015 and assisted to the revision of the professional standard for Pharmaceutical Manufacturing Technician (Level 4) considering the difficulties previously encountered at common application. After the review of the document by a specialist at writing professional standards, a second workshop took place on March 23-25 and the document has been simplified once again to be suitable to the usage of the entire industry.
* QbD: Quality by Design; PAT: Process Analytical Technologies
The 2015 ISPE Europe Annual Conference Driving Effectiveness in Pharmaceutical Operations with Integrated Quality will bring together pharmaceutical, regulatory and technology experts from around the world in Frankfurt in 4-7 May 2015.
This three-and-a-half-day, must-attend, education conference will use best practise case studies to explore current technologies, regulatory requirements and will provide delegates with techniques for the evaluation and implementation of cutting-edge technologies. The Conference is aimed at Pharma Development Experts, Quality Management, Quality Assurance, Quality Operations, Quality Control, Quality Systems, Production & Distribution Personnel, Professionals Involved in Manufacturing, Development and Technology Transfer as well as Suppliers and Regulators with interest in new solutions and experiences.
In-depth discussion through four tracks will cover cost-effective, flexible, sustainable manufacturing facilities design and implementation; the use of IT and advanced technology in the drug manufacturing; drug supply and inspections requirements; and drug submissions and quality by design. Details about the conference and registration form can be found in the following link: http://www.ispe.org/2015-europe-annual-conference
ISPE Turkey Affiliates PAT & QbD Workshop around the theme of Quality by Design Case Study will be held on February 26, 2015 at Santa Farma.
The workshop will be initiated following the opening remarks about the PAT & QbD workshop principles and targets from Fatma Taman, General Manager at PharmaVision who was appointed as Chair of ISPE Turkey Affiliates Board as of January 2015. A QbD case study will be presented by Dr. Buket Aksu, Corporate Relations Director at Santa Farma. The workshop will then continue with a Q&A session.
We look forward to your presence in this workshop for which attendance is complimentary.
Deadline for registration: 20 February 2015
While wishing health, happiness and success to all of our members and delegates of our industry in 2015, we would like to thank the Dean of Faculty of Pharmacy of Istanbul University, Prof. Dr. Ahmet Araman who handed over his task as Chairman of ISPE Turkey Affiliate for his support and contributions to our Association. We wish all the best to Mrs. Fatma Taman, General Manager at PharmaVision who became our new Chair and we welcome Mrs. Hulya Uslu who joined us as Office Manager as of December 2014.
ISPE Turkey Affiliates 2014 Fall Seminar around the theme New Approaches for Product Design and Production Controls took place on 21 November 2014 at Point Hotel Barbaros, Istanbul.
Following the opening speeches of Prof. Dr. Ahmet Araman, Chairman of ISPE Turkey Affiliate and Carl-Johan Hulten, Area Sales Manager at Umetrics, firstly a general approach to Quality by Design (QbD) was given by Dr. Buket Aksu, Corporate Relations Director at Santa Farma Pharmaceuticals. After the quite active introductory presentation, Design of Experiments (DoE), Multivariate Data Analysis (MVDA) and Process Analytical Technology (PAT) topics were described by Umetrics Application Specialist Dr. Olof Rosén, including also some software demonstrations and case studies. The seminar also incorporated a presentation on Innovative Solutions & Support on QbD by Cihan Sancaktaroğlu, Technical Manager at BASF and an efficient discussion panel with the contributions of the attendees. On this last session, the facilitator Fatma Taman announced that PAT studies within ISPE Turkey Affiliate will continue with specific workshops. We will be pleased to communicate with industry representatives who are interested in this topic and we would like to thank all speakers and attendees for bringing in their view and support.
In the ISPE Annual Meeting which took place on 12-15 October 2014 in Las Vegas-Nevada, Mass Serialization and Track & Trace Applications pioneered by our country were presented in two sessions by Fatma Taman, Vice Chair of ISPE Turkey Affiliate and the presentation was very well received by the audience. During the Annual Meeting, Buket Hekiman who handed over her task as Chair of European Affiliate Council made an end of tenure presentation about ISPEs European Activities. In addition, Chairman of ISPE Turkey Affiliate Prof. Dr. Ahmet Araman and Buket Hekiman served as judges for ISPEs international student poster competition. Taking pride in representing our country, we are committed to enhancing our contributions to ISPEs international organisations and administrative meetings.
A member of ISPE Turkey Affiliate Ufuk Agun has held a presentation about Project Quality Planning during the GEP-Russia 2014 conference, which was based on ISPEs Good Engineering Practices (GEP). In this conference, which took place on 24-25 September 2014 in Moscow, to which Czech, Russian, Turkish, Slovak and Italian speakers attended, ISPE has also been introduced and information has been given shortly about the activities of the ISPE Turkey Affiliate. The presentation raised great interest among the ca. 150 participiants and the Q&A session was very efficient, even led to some technical discussions. The mentioned presentation has been chosen as most vivid by the questionnaire performed by the organising company FAVEA.
Understanding Biologics and Biosimilars: An Integrated Approach
ISPE Turkey Affiliates Spring Seminar around the theme of Understanding Biologics and Biosimilars: An Integrated Approach will be held on May 16, 2014 at Faculty of Pharmacy of Istanbul University.
The seminar will be initiated following the opening remarks from Dr. Saim Kerman, Head of Turkish Medicines and Medical Devices Agency and will continue with presentations on production, quality, comparability and regulatory aspects of biological products and biosimilars. Related regulatory frameworks at EMA and FDA will be presented by Prof. Dr. Steffen Thirsturp, Former Department Head at Danish Health and Medicines Authority and by Dr. Andrew Chang, Former Acting Deputy Director at FDA.
The seminar will also include current assessment of biological industry in Turkey by Turkish Medicines and Medical Devices Agency via the speech of the authoritys Trainee Health Inspector Pharm. Adem Abay.
We look forward to your presence in this important seminar.
Prof. Dr. Ahmet Araman MSc. Pharm. Buket Hekiman
Deadline for registration: 02 May 2014
Pulmonary Drug Delivery Workshop
ISPE Turkey Affiliates workshop on Pulmonary Drug Delivery will be held on May 9, 2014 at Faculty of Pharmacy of Istanbul University.
Current developments with regards to cell physiology of the lung, characterization of respirable particles, pulmonary drug delivery systems and devices will be presented by related subject matter experts. The workshop will also include the assessment of pulmonary drugs by Turkish Medicines and Medical Devices Agency via the speech of the authoritys Clinical Assessment Unit Manager MSc. Pharm. Bilgen Beldüz.
We look forward to your presence in this important workshop for which academic participation is complimentary.
Prof. Dr. Ahmet Araman MSc. Pharm. Buket Hekiman
Deadline for registration: 30 April 2014
ISPE Europe 2014 Conference and Trainings
ISPE Europe Annual Conference 2014, around the theme of Driving Effectiveness in Pharmaceutical Operations within the New Quality Culture, will be held in Frankfurt on 28-30 April 2014. As ISPE is extending a special offer to encourage participation of the ISPE Turkey Affiliate Members, ISPE Members in Turkey may register for the event at the committee rate. Details about the conference and registration form can be found in the link below.
ISPE Europe Annual Conference 2014, 28-30 April 2014:
Moreover, details about ISPE trainings that will be held in Brussels on May 19-22, 2014 and in Barcelona on 8-10 September, 2014 can be reached from the links below.
"Raw Material Variability in Light of Qbd & PAT and Storage & Distribution Practices" Seminar of ISPE Turkey Affiliate was held on May 31, 2013 at Faculty of Pharmacy of Istanbul University with a wide ranging participation of 140 attendees.
The seminar which involved speakers from suppliers, industry and authority was initiated with the presentation titled "Raw Material Supply, Storage and Distribution Practices in Turkey and the Future Perspective" from MSc. Pharm. Fatma Bekar, Head of Quality Control Department of Turkish Pharmaceuticals and Medical Devices Agency.
The presentation which was very well received by the audience, was firstly followed by the speech of Dr. Theodora Kourti who elaborated on Raw Material Variability and the Effect on Product Quality and then by Nils Rottmann from BASF who comparatively evaluated several binders for Wet Granulation Processes.
Quality-by-Design Approach to Optimize Coating Process Parameters was presented in the afternoon session by James Gilmour from Colorcon, after which Dr. Theodora Kourti shared her experiences with regards to challenges of PAT Implementation, as well as related expectations from industry and authorities.
Examples of Good Storage and Logistics Practices were presented by Ms. Aslı Başaran Yamantaş from Alişan International Transport and the seminar was concluded after a very lively Q&A session. We would like to thank all the speakers and attendees for their great contributions to our seminar.
ISPE Turkey Affiliate 2013 Spring Seminar
Raw Material Variability in Light of Qbd & PAT
and Storage & Distribution Practices
ISPE Turkey Affiliates 2013 Spring Seminar will be held on May 31, 2013 at Faculty of Pharmacy of Istanbul University.
Speakers involved from suppliers, industry and authority will elaborate on raw material variability and the effect on product quality as well as QbD and PAT implementations, and will present examples of good storage and logistics practices.
We look forward to your presence in this important seminar.
Prof. Dr. Ahmet Araman Buket
Please click here for information about ISPE Europe Trainings to be held in Brussels on May 22-24, 2013.
ISPE Turkey's Fall 2012 Seminar on Containment was held on November 22-23 at Istanbul University, Faculty of Pharmacy.
The seminar was organized jointly with ISPE D/A/CH Containment COP, and the first presentation was made by the Chair of the Group Mr. Richard Denk (Hecht Technology) about Draft D/A/CH Containment Manuel. Second speaker Ms. Ela Canel Bodur (Mustafa Nevzat Pharmaceuticals), presented EHS Practices on Turkish Pharmaceuticals Industry. Following the lunch taken at the historical restaurant of the University, Dr. Nick Hutchinson (Parker) presented the Implementation of Single-use Technology for Potent Compounds and Mr. Martin Pernau (Bayer Healthcare) has elaborated on Containment Upgrade Pilot Plant Case Study, before going into a lively Q&A session.
The second day of the seminar started with a presentation from Mr. Richard Denk (Hecht Technology) about Highly Potent API Manufacturing and continued with Dirk Collins (Waldner) presentation on the New Developments in the Formulation of Parenteralia with Highly Active Substances. The visitors were taken to a tour on the Pharmaceutical Museum of the Faculty, after a very active Q&A session. We would like to thank all the speakers and attendees for their great contributions to our seminar.
ISPE Turkey is proud to announce that the Affiliate's 2012 Fall Seminar will be held on November 22-23, 2012 at Faculty of Pharmacy of Istanbul University.
We look forward to your presence in this important seminar.Respectfully,
Prof. Dr. Ahmet Araman Buket Hekiman
Please click here for details about the program flow and registration information.
Certified Pharmaceutical Industry Professional (CPIP) Program
ISPE offers the first independent, international competency-based professional certification for the pharmaceutical industry.
The Certified Pharmaceutical Industry Professional (CPIP) credential is for industry professionals around the world working in and supporting product development through manufacturing. As part of your professional development pathway, the CPIP certification program can unlock greater career opportunities for you and provide your company a competitive advantage, especially during challenging economic times.
Additional information about the program can be found in the appropriate links below. Please contact email@example.com until September 15th, 2012 if you would like to subscribe for a meeting (in Istanbul) where the program will be presented in a more detailed manner.
Prof. Dr. Ahmet Araman Buket Hekiman
ISPE Turkey's Spring 2012 Educational Seminar took place at Istanbul University, Faculty of Pharmacy, on April 27th 2012, with a wide ranging participation representing the entire pharmaceutical industry plus guests from the Ministry of Health, universities, suppliers and the Affiliate's Student Chapter.
The seminar started with opening remarks of Prof. Dr. Ahmet Araman, Chairman of the Affiliate. Following the opening speech, the new structure of Turkish Health Authorities was presented by three responsible officers of the Authority. The long open-discussion forum in the afternoon was very lively; many aspects of the Agency were sincerely explained by the speakers in regard to the questions addressed.
A conference on Quality by Design for Generic Medicines will be held by ISPE in Brussels on June 27th-28th. Details about the conference and registration information can be found in the link below.
June QbD Conference: http://www.ispe.org/2012qbdeuconference
ISPE Turkey's Fall Educational Seminar took place at Istanbul University, Faculty of Pharmacy, on November 22nd 2011, with a wide ranging participation representing the entire pharmaceutical industry plus guests from the Ministry of Health, universities and the Affiliate's student chapter. The seminar, which took place in a historical atmosphere, started with opening remarks of Prof. Dr. Ahmet Araman, Chairman of the Affiliate and Dean of the Faculty of Pharmacy. Following the opening speech, details of GMP inspections conducted in Turkey were presented by Ms. Sibel Gurer from the Turkish GMP Inspectorate.
Former Chairman of Pharmaceutical Inspection Co-operation Scheme (PIC/S) Mr. Robert Tribe (ISPE Regulatory Affairs Advisor for the Asia-Pacific region) presented PIC/S and elaborated on the benefits, for the regulatory authority and for the industry, of being a PIC/S member. The running of MHRA Inspectorate and its approach for overseas audits were presented by Mr. Bryan Wright (ISPE European Regulatory Affairs Advisor), former inspector of MHRA (Medicines and Healthcare Products Regulatory Agency) in accordance with the theme of the seminar: International initiatives and audits for a global pharmaceutical market.
The participants had the chance to visit the Pharmacy Museum of Istanbul University, as well as table top exhibitions of Glatt, Groninger and Parker during coffee breaks and enjoyed the lunch served in the historical atmosphere of the Universitys Mansion House.
Suggestions on how to handle regulatory GMP inspections were offered by Mr. Robert Tribe and Mr. Bryan Wright in the afternoon and potential collaboration avenues between Turkish Health Authorities and PIC/S were discussed during the long Q&A session.
ISPE Turkey Affiliate has been honored by the Golden Mortar Award, known as the Academy Awards (Oscars) of the Turkish Pharmaceutical Sector.
The award ceremony was held on November 1st, 2011 at Istanbul University Faculty of Pharmacy and this important award for Turkey Affiliates educational projects was presented to our Honorary Secretary General Mr. Selim Seyhan. A point that has been emphasized at the opening speeches has been the high number of attendees for the ceremony, as well as the fact that twice as many applicants compared to last year competed for this years award, both proving the increasing value of the Golden Mortar Awards.
Having received the award for its achievements in Pharmaceutical Manufacturing Technician project in high school level and Pharmaceutical Engineering curriculum performed in universities, ISPE Turkey Affiliate is committed to continuing its ever-increasing contributions to educational projects.
Starting with our Board members, we would like to thank all members of our Affiliate for their contributions leading to this recognition.
As a result of an active cooperation between ISPE Turkey Affiliate and the Ministry of National Education's General Directorate for Technical Vocational Education, Pharmaceutical Manufacturing Technician curriculum started in Turkey for the first time in 2008, at Kadırga Vocational High School, which has been chosen as a pilot school for the implementation of this brand new project aiming to bring up qualified technical personnel needed by our pharmaceutical industry.
To supplement this education on the application side, under the leadership of ISPE Turkey Affiliate and with great support from sectoral companies a Pharmaceutical Manufacturing Technician Training Laboratory was built and made available to students at Kadırga Vocational High School. The opening ceremony of this laboratory was held on October 5th, 2011 at Kadırga Vocational High School.
At the ceremony where this groundbreaking vocational educational project has been presented, the opening speeches were delivered by School Principal Mr. Bilal Bulut, ISPE Turkey Affiliates Chairman Prof. Dr. Ahmet Araman, Ministry of National Education's General Director for Technical Vocational Education Mr. Hüseyin Acır, Chairman of Turkish Pharmaceutical Manufacturers Association Mr. Cengiz Celayir and Mr. Refik Baydur, Honorary Chairman of Turkish Confederation of Employer Associations and Chairman of The Chemicals, Petroleum, Rubber and Plastics Industry Employers Association of Turkey. The visit of the Pharmaceutical Manufacturing Technician Training Laboratory, where students can prepare various pharmaceutical forms as placebo, took place after the official opening ceremony and the laboratory was highly praised by the audience.
We are grateful to all our stakeholders, starting with Ministry of National Education's General Director for Technical Vocational Education Mr. Hüseyin Acır and Kadırga Vocational High Schools teachers, who took part in this important project aiming to bring up qualified technical personnel for the pharmaceutical sector. Furthermore, we would like to thank Bayer, Eczacıbaşı-Zentiva, Glatt, Groninger, Pfizer and PharmaVision for their contributions to Pharmaceutical Manufacturing Technician Training Laboratory.
22 November 2011
"International Audits for the Global Pharmaceutical Market"
ISPE Turkey Affiliates Fall Education Seminar about international initiatives and audits for a global pharmaceutical market will be held on November 22nd, 2011 at Istanbul University, Faculty of Pharmacy.
Former Chairman of PIC/S (Pharmaceutical Inspection Co-operation Scheme) Mr. Robert Tribe will present PIC/S, elaborate on the benefits, for the regulatory authority and for the industry, of being a PIC/S member and also offer suggestions on how to handle regulatory GMP inspections.
Our second speaker Mr. Bryan Wright, former inspector of MHRA (Medicines and Healthcare Products Regulatory Agency), will present the running of MHRA Inspectorate and its approach for overseas audits and will also focus on common GMP deficiencies from MHRA point of view.
Ms. Sibel Gurer from the Turkish GMP Inspectorate will also be present to share her experiences on GMP inspections conducted in our country. We look forward to your presence in this important seminar.Respectfully,
As the attendance to the seminar is limited, registrations will be processed on a first come-first serve basis. Details about the seminar program and registration information can be found in the appropriate links below.
Seminar Program (In Turkish)
Speaker Resumes (In Turkish)
For more information please contact us.
As a result of an active cooperation of ISPE Turkey Affiliate with the Ministry of National Education's General Directorate for Technical Vocational Education, Pharmaceutical Manufacturing Technician curriculum started in Turkey for the first time in 2008, at Kadırga Vocational High School, which has been chosen as a pilot school for the implementation of this brand new project aiming to bring up qualified technical personnel needed by our pharmaceutical industry.
To supplement this education on the application side, under the leadership of ISPE Turkey Affiliate and with great support from sectoral companies a Pharmaceutical Manufacturing Technician Training Laboratory was built and made available to students at Kadırga Vocational High School. The opening ceremony of this laboratory will be held on October 5th, 2011 at Kadırga Vocational High School.
A conference on Delivering Cost Effective GMP Solutions will be held by ISPE in Brussels on September 19th-22nd. On November, there will be two more conferences in Brussels on Risk-Based System Validation (14-15 November) and Pharmaceutical Quality Systems (14-16 November).
Details about the seminars and registration information can be found in the appropriate links below.
ISPE Turkey 2011 Spring Educational Seminar was held on March 11th, 2011 in Ramada Plaza Hotel, İstanbul with the participation of delegates from pharmaceutical industry, suppliers, Ministry of Health, Pharmacy Faculties and ISPE Student Chapter. Projects accomplished during the term of 2008-2010 were presented by Dr. Ünsal Hekiman. Following the opening speech, the Affiliates Board members announced that, Dr. Ünsal Hekiman and Mr. Selim Seyhan, who had stated that they will not stand for election again, will remain as Honorary Chairman and Honorary Secretary General of the Affiliate and expressed gratitude for all their efforts and contributions to ISPE Turkey all the way from the inauguration up to the present successful situation.
During the morning session of the seminar, Dr. David Selby gave information about the emerging expectations of quality management systems after ICHQ10 and Mr. Bruce Davis focused on the importance of product and process understanding on facility design.
In between sessions, the new Board of the Affiliate, to be active during 2011-2014, has been elected. Prof. Dr. Ahmet Araman (Istanbul University Faculty of Pharmacy), Nuran Varolan (Pfizer), Tulu Veyisoğlu (PharmaVision), Fatma Taman (Abdi İbrahim), İlknur Hırçın (Bayer), Buket Aksu (Santa Farma) and Zehra Gürol (Karbomed) were elected to the Board, along with Şerare Atılgan (Santa Farma), Fahrettin Kazak (PharmaVision), Suat Kumser (Pfizer), Havva Aşar (Bayer), Fikret Uslu (Sandoz), Buket Hekiman (PharmaVision) and Nazlı Kuş (Abdi İbrahim) who were elected as reserve members.
The afternoon session started with Dr. David Selbys presentation about new trends on supplier quality systems and was followed by the presentation of Mr. Bruce Davis who explained in detail the importance and impacts of FDAs Process Validation Guide.
While the seminar provided real benefit to the attendants as newly published pharmaceutical guides and emerging requirements were discussed, the new Board has taken over by the elections held on the same day and the new officer functions were delegated on the first Board Meeting.
ISPE Turkey is proud to announce that the Affiliate's first education seminar of the year will be held on March 11th, 2011 in Ramada Plaza Hotel, Sisli, Istanbul.
Globally recognized experts in their fields, Dr. David Selby and Bruce Davis, who had previously been speakers in ISPE Turkey's past educational seminars, will elaborate at length on the new developments having impact on harmonized inspections. Dr. Selby will define the effects of ICH Q10 on quality management systems in terms of universal pharmaceutical quality standards and will give information about new trends in suppliers' quality systems in FDA and EMA environments. Mr. Bruce Davis will highlight the contribution of process and product understanding to facility design and in light of the foregoing will present the impacts of FDA's newly published Process Validation Guide on facility inspections.
As the attendance to the seminar is limited, we would like to remind you that the registrations will be done on a first come-first serve basis. Details about the program flow and registration information can be found in the appropriate links below.
We look forward to your presence in this important seminar.
Seminar Program (In Turkish)
Speaker Resumes (In Turkish)
For more information please contact us.
ISPE Turkey's Fall Educational Seminar took place on October 11th, 2010 with a wide ranging participation representing the entire pharmaceutical industry plus guests from the Ministry of Health, universities and the Affiliate's student chapter. With opening remarks of Dr. Hekiman, Affilite Chairman, ISPE Turkey's goals, accomplishments and ongoing projects were explained in detail. Prof. Araman from the Istanbul University, Pharmacy Faculty Dean, talked about the important interactions and collaboration avenues between universities and the the industry.
Our next speaker, Dr. Janice Soreth, FDA Europe's Deputy Director, in her morning presentation, explained FDA's views on risk analsis approaches with emphasis on quality audits and supplier selections on a global base and the difficulties and complexities entailed on such a big project. Her afternoon talk focused on applications and case studies of joint FDA-EMA audits and expansion, both present and future, into other regulatory authorities. A long question and answer session, where many aspects of the FDA agency were sincerely explained by one of its responsible officials, also witnessed candid views of both Dr. Soreth and Prof. Araman on the participant's questions regarding future interactions between FDA and Turkish regulatories particularly in light of growing global importance and size of the local pharmaceutical market.
ISPE Turkey will organize the second and last seminar of this year in Ramada Plaza Hotel (Şişli-Istanbul) on October 11th, 2010 with its esteemed speaker invited from the FDA.
The harmonization initiatives, globally in progress, will be evaluated by the representative of the most authoritative agency. Dr. Janice Soreth, Deputy Director of FDA Europe will consider the status of two important areas in this context. After speaking about FDA's approach on risk analysis pertaining to GMP aspects, she will then elaborate on the joint pilot inspection projects initiated by FDA and EMA.
To enable ample discussion period on these topics as well as other general informative questions relating to FDA, we have organized a more comfortable time schedule for this seminar. As the participation capacity of this seminar is limited, registration will be performed on a first come- first serve basis. From the links below you can access the program as well as registration details.
We look forward to your presence in this important seminar.
Seminar Program (In Turkish)
Speaker Resumes (In Turkish)
For more information please contact us.
The Pharmaceutical Manufacturing Operator Occupational Standard was published in the official journal dated 12.05.2010 thus becoming the first occupational standard in the chemical industry.
I personally think that we all feel a sense of pride and joy for what we have accomplished for our country's pharmaceutical industry through this joint effort. For their valuable contributions, I would like to extend my thanks individually to the members of our management board and to the the commission members involved in this project.
Work in establishing the other two occupational standards Pharmaceutical Logistics Operator and Pharmaceutical Manifacturing Maintenance Technician " is in progress in coordinatian with KIPLAS.
I hope to share good news with you in the near future in these endeavors as well.Dr.Ü.Hekiman
ISPE-International Society for Pharmaceutical Engineering
Chairman of the Executive Board
The link for the standard is provided below:
Istanbul University Pharmacy Faculty ISPE Student Chapter, which is attached to our ISPE Turkey country Affiliate, has won the Society's 'Student Chapter of the Year' award in a competition of over 60 student chapters worldwide. The award ceremony was held during the ISPE Annual Meeting held in San Diego, USA on November 8-11 and was attended by all the attendees of the meeting, generally considered the largest of its kind in the industry.
We congratulate our students as well as their Academic Advisor, Prof.Ahmet Araman, for this important achievement.
With this success and the 'Affiliate of the Year' award obtained in 2007, ISPE Turkey has thus succeeded in bringing 2 important awards granted by ISPE to our country in the past 3 years.
10th April 2009
ISPE Turkey is proud to announce that the Affiliate's first education seminar of the year will be organized on April 10th, 2009 in the Istanbul Chamber of Industry (Odakule Building).
With only 2 years after its inauguration, ISPE Turkey has been awarded the "Affiliate of the Year" recognition for 2007 in the Society's Annual Meeting held in Las Vegas, November 4-7, 2007. Our regular and highly popular Educational Seminars, rapid increase in the country membership numbers, timely electronic publications of the Affiliate website and Newsletter, our regional PAT COP workshops integrated into the current global trends as well as our committment and solid support we have demonstrated in our university relations and education, have been cited for this acknowledgement.
Following the implementation of the much needed "Pharmaceutical Engineering" class in Istanbul University's Pharmacy Faculty in March of this year as a first in the country and with considerable input from our Affiliate, a Student Chapter was chartered in this institution with the official writing of ISPE Headquarters. In a ceremony held on December 4th in the Pharmacy Faculty, our Affiliate Chairman Dr. Ünsal Hekiman handed over the official charter to the Student Chapter of Istanbul University, Pharmacy Faculty.
Pictured in the photograph are (from left) Prof.Günay Sarıyar, Dean of the Pharmacy Faculty, Mr.Onur Dal, President of the Student Chapter, Prof. Ahmet Araman, Head of the Pharm. Technology Dept. and Academic Advisor and Dr. Ünsal Hekiman, ISPE Turkey Affiliate Chairman and Industrial Advisor.
28th March 2008
Turkey Affiliate will hold its next Educational Meeting on March 28th in Istanbul on the topic of GAMP 5. Speakers will be covering the current state on this important guidance for the Validation of Automated Systems. A pioneering name in this area, Dr.David Selby, will be one of the day's speakers. Emphasis will be given to practical solutions to "real world" cases.
The premier pharmaceutical manufacturing event of the year, the ISPE Annual Meeting was held on 4-7 November, 2007 in Las Vegas, USA . The Turkey Affiliate was represented by our members Selim Seyhan, Kerem Özensel and İrem Özensel. In the awards ceremonies on November 6th, our Affiliate was honored by receiving the "Affiliate of the Year" award for its achievements in innovation, rapid growth and contributions to the Society.
The award was presented to our secretary-general Selim Seyhan by the immediate past Chairman of the Board, Jane Brown and the Chairman of the Board, Bruce Davis.
This important recognition achieved in such a short period after our inauguration should enhance Turkey's credibility in the global pharmaceutical platform. We are grateful to all our members for their individual contributions toward this success.
Berlin - 17-20 September 2007
The Product Quality Lifecycle Implementation (PQLI) initiative, started by ISPE and supported by the FDA, was launched in June 2007, and borne from the need to help the global pharmaceutical industry find solutions to the challenges in implementing the current ICH guidances. (ICH Q8,Q9,Q10) The first European session of PQLI will be held on September 19th at ISPE's Berlin Conference.
The Fall 2007 educational seminar of ISPE Turkey will take place in September and the topic will be "Quality Risk Management in Pharmaceutical Manufacturing-ICH Q9".The date and program as well as the speakers are currently being determined and shall be announced shortly. There will be case studies as well as interpretations of this important Guideline by experts.
The fourth workshop of ISPE Turkey's PAT-Community of Practice was hosted by Abdi İbrahim İlaç factory in Istanbul on May 30th, 2007. Twenty participants representing member companies Abdi İbrahim, PharmaVision, Pfizer, Santa Farma as well as the University of Istanbul/Faculty of Pharmacy took part in this educational event. S.Seyhan's (PharmaVision) opening remarks summarized the work done so far and focused on the importance ISPE places on this topic and the need of exchanging experiences between fellow Affiliates as also emphasized strongly by the Society's CEO/President Robert Best. The Turkish team now has in place a 9 point roadmap , with individual point topics allocated to member companies to prepare presentations at these workshops. Murat Dönmez and Barış Altunışık then presented two well prepared talks on design of experiment (DOE) and process capability, respectively, topics serving as fundamental background for the PAT understanding.
After a lunch break at the plant's recently opened modern cafeteria, the short afternoon session entailed an overview and reevaluation resulting in minor modifications. The next workshop is scheduled for September of this year.
The next activity of the Turkish Affiliate will be a working session of the PAT interest group. Holding their 4th meeting, this time at Abdi İbrahim İlaç company's Hadımköy factory site on May 30th, the group will start working on the 9-point PAT Turkey roadmap rolled out at the Affiliate's March Educational 'Containment' seminar in Istanbul. On the agenda are presentations on Design of Experiment (by Murat Dönmez) and on Process Capability &Performance Analysis (by Baruş Altunışık). We hope to welcome new members in this meeting.
The newly inaugurated student chapter of the Turkey Affiliate established in Istanbul University's Pharmacy faculty held its first working meeting with the Affiliate's officers in Istanbul's Kalyon Hotel on May 28th, 2007. Ten elected officers and members at large of the student chapter, having studied the "ISPE Student Chapter Handbook" were given a briefing by their Industry Advisor and Affiliate-Chair Dr.Ü.Hekiman and their Faculty Advisor Prof.A.Araman as well as Affiliate-Secretary S.Seyhan as to the mission of ISPE and the importance it attributes to its academic/student relations.
Chapter President O.Dal, Vice President B.Çelebi, Secretary G.Gökdemir and Treasurer A.Cömert together with their members will primarily work annually on two projects and report on their conclusions. To assure the continuity of the chapter, emphasis will be on recruiting juniors and sophomores. A number of projects were discussed as well as topics for potential industry presentations of current interest.
The Turkish Affiliate gives special importance to the education of students in view of the fact that they are the future of our pharmaceutical industry. Realizing the need of pharmacy students to be better equipped with knowledge about this industry, a cooperation was started with Istanbul University's Pharmacy Faculty. Officers of the Affiliate examined various 'pharmaceutical engineering' programs in the US and Europe and helped to structure a course, which has started this semester in the faculty. Course instructor is Prof. A. Araman, who has asked Affiliate Chairman Dr. Ü. Hekiman to provide speakers from the industry to serve as guest lecturers.
Led by the company PharmaVision, several ISPE members have agreed to contribute their time and energy for this worthy project. Already lectures in factory organization, quality affairs, environmental topics, engineering aspects including qualification, validation and design aspects were given with a very positive response of the student body numbering 22.
ISPE Turkey intends to further support this program by encouraging the formation of a student chapter from participating students as well as rewarding successful students in the class by giving them free student memberships and seminar entrances.
In coming years, Istanbul University's Pharmacy Faculty intends to develop a specialized expert 'Pharmaceutical Engineering' program out of the current course. Besides Istanbul University, already other pharmacy and engineering departments have expressed their interest to ISPE Turkey for cooperation to start similar pharmaceutical engineering curriculums in their institutions.
We are happy to announce the first educational seminar of ISPE Turkey in 2007. The topic of this seminar will be containment, a topic of increasing importance of the last years, both in terms of technological advancements and GMP. Containment is a technology concept covering the protection of both the worker and the manufacturing environment in API and dosage form pharmaceuticals.
Lead speaker of this event will be recognized expert of this technology, Mr. Nichols from Foster Wheeler Company. He will share with us in 2 presentations, both containment's increasing importance and necessity in today's manufacturing practices as well as practical case studies.
Our other speakers Messr. Belger, Denk, Davies and Leach will discuss containment technologies and issues relating to equipment, sampling and process stages. The seminar will also feature a presentation on PAT by Mr. d'Aramon from Pertience Company about process understanding based on fact-based control strategies.
ISPE Turkey Affiliate with only 1 year after its inauguration has made considerable progress in achieving another goal, a curriculum for Pharmaceutical Engineering in Turkey's universities. We are pleased, that, in this seminar we also have Prof. Günay Sarıyar, Dean of Pharmacy Faculty of Istanbul University, and Prof. Ahmet Araman, Head of Pharmaceutical Technology Division of same faculty, to make introductory remarks about the implementation of this program.
Not even 1 year old, ISPE Turkey Affiliate activities are already being appreciated by the Turkish pharmaceutical community. Our third educational seminar in September was very well attended; meanwhile our membership has also approached 150, much ahead of the yearly goal.
We are also emphasizing participation in international meetings. Our Chairman and Secretary General took part in ISPE Annual Meeting in Orlando earlier this month. They attended various educational seminars (e.g. ICH Q8 & Q9, RFID Trends, PAT and Continuous Processing, Case Studies on Innovation in Facility Design) besides the Affiliate gatherings with their inputs. Contacts with several colleagues and instructors will be beneficial as far as future activities in Turkey and mutual co-operations are concerned.