Seminar 1 - Diary by William Chin

Agenda of Seminar 1

Freiburg, Sept 16, 2013 - The first installment of the 10 seminar series in Regulatory Affairs for Biopharmaceuticals including ATMPs was organized by EUCRAF at the Hotel Novotel Am Konzerthaus, Freiburg on the 10th Sept 2013. The theme of Seminar 1 was “European Pharmaceutical Regulatory Environment”. Over the course of the four-day meeting, participants were exposed to the legal basis of authorization of medicinal products and biopharmaceuticals as well as registration of medical devices and drug/device combinations. In addition, this seminar provided the aspiring and current Regulatory Professionals a better understanding and guidance in the evolving pharmaceutical regulatory requirements of the European Union. Various distinguished speakers from the industry and former competent authorities imparted in depth knowledge and shared their experiences to the participants.

On the first day, Dr. Gabriele Dallmann (EUCRAF) gave a hearty welcome and introduction to the participants. In her presentation, Dr. Dallman presented a comprehensive overview of the MSc EUCRAF course work. This program is a joint cooperation between EUCRAF and the University of Strasbourg that will be awarding Master II <Science du medicament specialite> “Regulatory Affairs for Biopharmaceutical” to its full time participants who completed all the 10 seminar series. A total of 22 full course participants from various nationalites (British, Belgian, Bulgarian, Chinese, French, German, Italian, Polish, Russian, Singaporean and Spanish) were present in the seminar, giving it a truly global cohort of students. Most of them hold a doctoral degree in their respective field of expertise with working experiences either in the industry, academia or research institute.

After the formality of introduction, the morning session kicked off with a lecture on the introduction into the European regulatory system by Geneviève Michaux, a leading regulatory lawyer in Europe (Hunton & Williams). Geneviève has shared her extensive years of experience on issues surrounding the European regulation of drugs, biologicals, and medical devices, both at the Union and national level. The presentation was concluded with an observation that the trend in pharmaceutical regulation is moving towards a more centralized system with greater regulatory discretion. The marketing authorization is now seen as a public health tool that allows for public accountability in health care through the increase of transparency with the regulatory authorities.

The afternoon session was chaired by a group of panelist that brought together three senior experts in Drug Regulatory Affairs and Intelligence from Novartis: Dr. Judith Creba, Dr. Genevieve Le Visage and Dr. Silvia Pfaff. In this session, the functions and roles of the various regulatory institutions and other pharmaceuticals stakeholders of the European system was discussed in details, giving an exhaustive understanding of the whole interaction within network. We have learned that the European Medicine Agency (EMA) is a result of various legislative texts that has morphed into a highly organized secretariat that taps into the expertise of other health authorities from its member state to evaluate marketing authorization of pharmaceuticals. Currently, there are 7 specific scientific committees created for a given legislative task: Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO), the Committee for Advanced Therapies (CAT) and the Pharmacovigilance Risk Assessment Committee (PRAC). EMA is currently being restructured to improve its operation and efficiency. The increase involvement of patients in EMA’s committee reflects the agency’s commitment to ensure that medicines have a positive risk-benefit balance in favor of patients and users of these products. Further elucidation was also given on the national agencies of the EU/EEA member states and The Head of Agencies (HoA) network. The role of these agencies is clearly defined in the respective national legislation, and the coordination of activities is important to ensure efficient implementation of EU Directives. The first day of the seminar ended with a presentation on the Industry Trade Associations who also plays a key role as stakeholders in representing the consensus voice of the industry in institutional dialogues.

The second day of the seminar series was facilitated by Dr. John Purves (formerly EMA). Dr. Purves spans a career of over 35 years working with regulatory authorities at both national and Union level, has considerable experience in the development of legislation, guidelines and of the review procedures for dossiers. Among the topics lectured were the development of biologic legislation and control of biologics in Europe and future pathways; and legal particulars for Advanced therapies, Emerging therapies and technologies, Biosimilars, Plasma and Vaccine Antigen Master Files, Genetically Modified Organism (GMO), Batch release and Small and Medium Size Enterprises (SME).

In the afternoon, a video seminar was conducted by Dr. Marielle Fournier (Voisin Consulting) on the EU and USA regulatory framework for drug/device combination products. After an intensive day of lectures, EUCRAF organized a dinner at lovely traditional German restaurant in the heart of the old town in Freiburg. This gathering provided an opportunity for participants to relax and encouraged social interaction and the discovery of each other’s cultural as well as professional background.

On day 3, Dr. Lidia Cánovas (Asphalion, S.L.) and Dr. Michael Schaub (Asphalion, S.L.) gave an excellent overview of the Common Technical Dossier (CTD) that is used to apply for a marketing authorisation in the EU, US and Japan. The objective of this session was to provide a good understanding of the CTD structure and knowledge to handle all changes and variations occurring during the life cycle of a medicinal product. In depth presentation was given on Module 1 and Module 2, explaining the rationale of various sections. In addition, Risk Management Plan (RMP) was also dealt with.

On day 4, Dr. Purves continued to moderate the session by discussing on the international collaboration of the three regions: EU, US and Japan; through the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It was observed that there are visible efforts to harmonize many aspects of drug development leading to global efficiency among the different regulatory agencies. Despite an overall increase in harmonization, Dr Purves stated that certain areas such as pharmacovigilance, pediatric development and biosimilar approvals is somewhat less harmonized, due to different requirement and lack of agreement among the reqions. Among the other highlights discussed include the collaboration with other agencies in China, India and Brazil (Latin America). The overall diversity in this three regions leads to various hurdles in marketing authorization and this calls for a careful harmonization in order to balance the local market as well as the global market. Dr Purves then presented on the EU incentives offered to Small and Medium Size Enterprises (SME). This include regulatory, administrative and procedural assistance from the EMA SME Office and substantial fee reductions for scientific advice, scientific services, pre-authorisation and post-authorisation inspections.

In the afternoon, Dr Rembert Elbers (formerly BfArM) gave a presentation on Orphan Medicinal Products in the EU/EEA, detailing the legal basis and provision of orphan designation. Since the adoption of the Orphan regulation in 2000, EMA has provided incentives to pharmaceutical companies to encourage the development of orphan medicinal products. These include market exclusivity, as well as fee exemptions and reductions for several other EMA services critical for marketing authorization procedure of orphan drugs.

On the fifth day, a debrief session was conducted by Dr. Dallmann and Dr. Purves exclusively for the full course participants. The primary aim of this session was to consolidate the knowledge and understanding gained throughout the week as well as to address questions from the participants. At the end of this session, participants were tested on the material covered. Overall, this 4-day intensive program oversaw a lively interactive discussion between participants and lecturers. Participants have gained profound insights into the key issues in the European Pharmaceutical Regulatory Environment.

William Wei Lim Chin EUCRAFWilliam 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.