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Description: In today’s market, it’s critical to utilize every avenue possible to optimize your drug development pathway. One of the key components to an efficient and successful marketed drug is a close collaboration with Regulatory Affairs experts. This webinar will describe in detail how and where in the drug development process Regulatory expertise can add the necessary insight to ensure improved efficiency and success. Specifically the webinar will answer such questions as: when should a scientific advice meeting be scheduled with the authorities, and what information will be obtained? When is an IMPD needed vs. a simplified IMPD? How to proactively address the most frequent questions raised by the Health Authorities on the IMPD.
Author’s Bio: Rene Mignolet, Ph.D., MBA has acquired over 24 years of experience in the pharmaceutical and biotech industry, specifically covering all regulatory aspects of new medicinal product development and registration mainly biotechnology derived products including cell and gene therapy. In his previous position as the Director Regulatory Affairs for Wyeth, in charge of Europe and the Middle East, Dr. Mignolet developed a personal network of contacts within the EMEA, the European Commission, the European Pharmacopoeia and the Official Medicine Control Laboratories. Dr. has developed regulatory drug strategies for over 30 U.S. and EU pharma and biotech companies, as well as WHO.