Seminar 6 - Diary by William Chin
Freiburg, June 23, 2014 - Seminar 6 entitled Pharmacovigilance: Post – authorization surveillance standards to meet regulatory requirements for product safety, was held on the 11 – 14 June 2014. The course leader was Dr. Monika Pietrek (Pietrek Associates GmbH), assisted by Christine Bendall (Pharview Ltd) and Dr. Gly Belcher (PV Consultancy UG). All three speakers are well-recognized experts in the field with extensive experience in pharmacovigilance and drug safety in clinical development.
A total of 18 participants attended this seminar, making the group interaction and engagement very effective. Although earlier in the previous seminars, we have been introduced to the function of Pharmacovigilance Risk Assessment Committee (PRAC) and the concept of pharmacovigilance, it has only now become clear of how it is being implemented and its impact on the industry and public healthcare sectors. The four-days seminar focused on training on regulatory processes related to pharmacovigilance. The use of case study approach was the highlight of this seminar. Almost after every presentation, we were given practical examples through case studies. I personally learn more effectively during discussion of case studies because it encourages active involvement in the learning process. The speakers had not only taught us how to think critically and assess adverse events but also how to perform adequate benefit-risk assessment. Even though the so-called new pharmacovigilance legislation became applicable in July 2012, some aspects of it are still evolving. From the discussion with the speakers, it is evident that efforts are being directed to reduce the administrative burden on both companies and regulatory agencies, and to avoid duplication of effort. If it weren’t for the speakers, especially Dr. Pietrek, to guide and explain which systems and processes must be adhered for safety reporting, we could probably miss some important points if we were to try to understand the regulation ourselves. In conclusion, we have gained insights to the fundamentals of product safety and pharmacovigilance systems. Topic such as quality control, pharmacovigilance inspections and audits, risk management systems, reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies and signal management were discussed comprehensively.
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.