Vice President (Technical)
Parexel, Ireland
Michael Craig is a Parexel Vice President (Technical) and former Pharmaceutical Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA). He has more than 10 years of experience in working in CMC and regulatory affairs, including 6 years licensing medicines at the agency. His assessment work for MHRA entailed national and EU initial applications, which covered EMA centralised procedures, DCPs, MRPs, and NCEs. Michael also provided scientific advice on behalf of MHRA and CHMP. Michael was part of team that helped establish the MHRA Innovation Office as an entry point for early-stage regulatory advice for innovative products and methodologies, and was the UK representative for the growing EU Innovation Network chaired by the EMA Innovation Task Force. In his current position with Parexel, he has helped clients prepare their CTA/IND, MAA/NDA and variation submissions as a CMC subject matter expert (and provided regulatory, strategic, and technical input for lifecycle activities in European and international markets. Michael is a RAPS member and has contributed to RAPS publications on regulatory strategy and quality management systems, as well as to the Fundamentals of EU Regulatory Affairs (8th ed.).
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EU Regulatory CMC Strategies and Challenges
Thursday, May 11, 2023
16:45 – 17:45 CEST