Risk Minimization/Mitigation in the Post-Marketing Arena: Regulatory Landscape, Strategy and Effectiveness

Mazhar Thakur, MD, MBA, MAMM, Senior Director, Safety and Risk Management, PRA

Dr. Mazhar (Maz) Thakur, the senior director of Safety and Risk Management at PRA, is a Pharmaceutical physician with specialized expertise in Risk Management and Safety Surveillance. He is a doctor of medicine from King Edward Medical University with postgraduate management qualifications from Middlesex University, London. His professional career comprises clinician in primary and tertiary healthcare, academia, scientific consulting in biomedical research and scientific management experience in the global bioPharmaceutical and CRO industry. In his 14 years with the bioPharmaceutical industry, Dr. Thakur has contributed to several global clinical development programs for top 10 bioPharmaceutical companies to midsized biotech companies in several therapeutic areas including oncology, neurology, immunology and infectious diseases. In academia, he has supervised industry related research projects at University of Cambridge and taught at Middlesex University. His experience encompasses risk management planning and implementation, signal detection, clinical development plans and regulatory strategy. He has also led Scientific Advice for monoclonal antibodies and Qualification Advice for novel biomarkers with European Medicines Agency (EMA) and has led negotiations with EMA for several risk management programs. With his publications on Risk Management and Effective Healthcare Communications, he has presented on these topics at several international forums and conferences.

In the bioPharmaceutical and CRO industries, Dr. Thakur has served in numerous key roles, including interim director roles in the disciplines of risk management and safety surveillance, clinical development and regulatory strategy before joining PRA.

Agnes Rivaille, Scientific Affairs Director, Late Phase Services, PRA

Ms. Rivaille has over 25 years experience in clinical research within the Pharmaceutical and CRO industries and has a proven track record in building and developing international peri- and post- marketing programs in multiple therapeutic areas including diabetes, respiratory, psychiatry, rheumatology, cardiovascular, neurology, and oncology. She has gained broad experience through various management positions in clinical operations, late phase development, and Pharmaceutical marketing. Ms. Rivaille’s experience expands into strategic and market analysis in support of products launch and reinvigoration of brand. She also has directed programs focusing on patient reported outcomes (PROs) and health economics.

Ms. Rivaille is currently responsible for providing consulting services and developing EU-RMP/REMS and peri- post-marketing operational strategies together with her colleagues at PRA. Her expertise covers defining needs and outcomes research, program design and data evaluation of studies in drugs, medical devices, biomarkers/diagnostics and combination products. She provides oversight and direction for the study implementation of large simple naturalistic trials and non-interventional studies and efficient processes for the improvement of the credibility and validity of the data, their analysis, interpretation and reporting.

Ms. Rivaille represented PRA as a speaker at various Late Phase meetings and congresses and communicated recently on EMA guidelines for PASS and Data Quality in Non-Interventional Studies.