Seminar 3 - Diary by William Chin

Agenda of Seminar 3

Freiburg, Jan 3, 2014 - Seminar 3 kicked off on the 4th December 2013 in Freiburg. It was the last seminar of the year 2013 and Christmas mood was in the air. A total of 20 participants and 4 speakers attended this seminar. This seminar was oriented at the theme of registration of Blood Products, Vaccines and Advanced Therapy Medicinal Products (ATMPs). The first day of the seminar was led by Dr. Zaklina Buljovcic, PharmaLex, where she spoke on the topics of regulatory procedures for ATMPs followed by case studies illustrating the challenges in the development of ATMPs. The topic is really interesting for us because the development of ATMPs is a rapidly expanding field of gene therapy, somatic cell therapy and tissue engineering which brings new challenges in terms of the manufacturing, traceability, efficacy and safety. These challenges are reflected in the regulatory guidelines that govern products in this class. The topic of ATMP classification procedure and the hospital exemption for selected ATMPs stimulated some interesting discussions.

The 2nd day of the seminar began with the presentation of the product class of blood products by Dr. Gabriele Dallmann, EUCRAF. Processing blood into various types of plasma-derived products is a highly specialized process due to the nature of its biologic starting material. The regulations at regional, national and international level set the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. The overall goal of the National Regulatory Authorities in EU is to ensure that only blood products of demonstrated quality, safety and efficacy should be used. The afternoon session was conducted by Dr. Jens Vollmar, GSK on the topic of Vaccines. His presentation has given us the opportunity to understand development path of vaccines from the conception of idea and its scientific research to licensure of the product. Cervarix was used as a case study to discuss the example of successful authorization of a HPV vaccine.

Picking up from Dr. Vollmar’s talk on the topic of Vaccine, Dr. Michael Pfleiderer, Paul-Ehrlich-Institut, led the session on day 3. As the Chairman of the Vaccine Working Party and Chairman of the CHMP/BWP Influenza ad hoc Working Group, Dr. Pfleiderer brought in regulatory perspectives in the registration of vaccines. He presented on the pre and post authorization documentation requirements for pandemic influenza vaccines. It was particularly interesting to learn that the European Medicines Agency has put 2 procedures in place to speed up the assessment and authorization of vaccines for use during a flu pandemic: the mock and the emergency procedures. The mock up pathway is set up in anticipation of future virus strain before a pandemic is imminent in order to develop and authorized pandemic-influenza vaccines in advance. The emergency procedure facilitates fast-track approval (70 days instead of 210 days) of a new vaccine developed after a pandemic has been declared.

On the 4th day of the seminar, we were requested to work in groups and prepared presentation on the topics that were discussed in previous days. This interactive group activity was a useful way to exchange viewpoints among us, as well as responding to questions from members of the other groups. Because it involved on-the-spot interaction, the evaluation session was, in my opinion, very engaging and a good learning experience. The farewell lunch rounded out our schedules of Seminar 3 and we said our goodbyes to each other and we looked forward to our Christmas holidays. On this note, I wish everybody a happy new year and see you soon in Seminar 4.1.

William Wei Lim Chin EUCRAF

William Chin is currently undertaking Master’s in Regulatory Affairs for Biopharmaceuticals at EUCRAF and previously obtained a Ph.D. in Biomedical Science from the Department of Pharmacy, National University of Singapore.