Seminar 8 - Diary by William Chin
Freiburg, Sept 11, 2014 – It has been a year since I started my journey as a full time student with EUCRAF. I attended Seminar 1 around the same time last year in September 2013, with the hope of transitioning my career path from being a laboratory scientist to a regulatory affair professional. And last week, it was my 9th seminar at EUCRAF. Entitled “Scientific Advice, Regulatory Strategy And Health Technology Assessment”, Seminar 8 was held on the 03 – 06 September 2014 at the Novotel Hotel in Freiburg. A total of 25 participants attended this seminar. Here is a brief summary of the high-caliber speakers who taught at the seminar:
- Dr. Gabriele Dallmann, EUCRAF Study Director, is an ex-regulator from Paul-Ehrlich-Institut, Germany, who has been involved in various committees and working parties at EMA in London.
- Dr. Simon Day, Clinical Trials Consulting & Training Limited, is an expert in clinical statistics and an ex-regulator at the UK Medicines and Healthcare Products Regulatory Agency and EMA in London who has served in many distinguished academic committees.
- Dr. Jacques Mascaro, Merck Serono, is a Senior VP of Global Regulatory Affairs and Quality Assurance who has extensive experience in the pharma industry.
- Dr. Susanne Heiland-Kunath, Takeda, is the Head of Regulatory Affairs Europe, Vaccine Business Unit who has many experiences in European Scientific Advise procedures and FDA meetings.
- Dr. Josefine Buth, Biotest AG, is the VP Corporate Regulatory Affairs who has more than 10 years of experience in the field of biologics.
- Dr. Bruno Flamion, NDA Regulatory Advisory Board, University of Namur, is an ex-regulator for the Belgian Federal Agency for Medicines and Health Products and EMA.
- Beate Schäfer, Bristol Myers Squibb, is the Head of Regulatory Sciences and Pharmaceutical Quality Assurance who has more than 20 years expertise in Regulatory Affairs.
- Dr. Denis Bourgarel, European Patent Attorney & French Patent Counsel, is molecular biologist turned patent attorney who has been working in the patent field for the past 13 years.
- Dr. Heike Wachenhausen, Wachenhausen Rechtsanwälte, formerly Novartis, is a regulatory lawyer who provides advice on regulatory matters relating to medicinal products and devices on German and European level.
- Dr. Jan Müller-Berghaus, Paul-Ehrlich-Institut, a clinical assessor of the section Monoclonal and Polyclonal Antibodie at the Paul-Ehrlich-Institut, Germany.
- Benita von Glahn, Boehringer Ingelheim, is the Head of Development of Regulatory Affairs for Biosimilar.
So what have I learned from this seminar?
Before submission of a Marketing Authorization (MA), there are a lot of pre-marketing interactions with regulatory agencies. One important interaction is known as the Scientific Advice. This is a meeting organized by the company with EMA or National Agencies, to provide responses to specific questions pertaining to the quality, safety and efficacy of medicinal products. It is not in the scope of scientific advice to provide a pre-assessment of data, but there will inevitably be some element of data discussion in terms of completeness of MA file before submission. Before organizing a Scientific Advice, one must have a strategy. A regulatory strategy is an approach that aligns the regulatory activities and business strategy to bring a new medicinal product to the global market. For existing products, regulatory strategy can be implemented during the introduction of changes in the manufacturing process. A regulatory plan is a deliverable that describes the regulatory intelligence and regulatory risk assessment to successfully meet the regulatory strategy objectives. Have I managed to confuse you? Well, hopefully not! The concept of Intelectual Property in the pharma industry was also discussed. A patent is a right to exclude competitors from practicing the invention in a territory for a certain period of time. On the other hand, regulatory data exclusivity is used to prevent generic competition from entering the market until the period of data exclusivity is over. Importantly, regulatory data exclusivity is independent of patent protection. And last but not least, Health Technology Assessment is an advisory procedure for drug reimbursement. It is basically a scientific appraisal for accessing cost-benefit of the medical product and technology on the quality of life of patients. There is a diverse range of national HTA processes and hence there is a need for HTA harmonization across most European healthcare systems. This initiative is already started through the EMA and HTA Parallel Scientific Advice procedures.
What I have written so far is just a very brief summary of the topics that we have learned over the course of 4 days. This seminar is different from the previous ones because it did not focus on laws, guidelines and directives, but more on the strategic and tactical roles of Regulatory Affairs in project teams. I have learned a number of key factors that support global regulatory strategies and the preceding considerations. There are many more details to consider and I am just so glad to have the lectures slides as my source of reference :-)
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.