ISPE - Turkey Affiliate

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.

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.

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.
Starting with our Board members, we would like to thank all members of our Affiliate for their contributions leading to this recognition.

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.

Turkey Affiliate Receives Big ISPE Award

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.

PAT COP

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.

Student Chapter

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.

ISPE Turkey's Contribution to Pharmaceutical Education in Turkey

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.

Containment Seminar - 2 March 2007

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.

ISPE Annual Meeting

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.

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