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Learning Level: Advanced
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Learning Level: Foundational
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Learning Level: Intermediate
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Student Focus

Michael Craig

Vice President (Technical)
Parexel
Enniscrone, Sligo, Ireland

Parexel vice president (technical) and former pharmaceutical assessor at the MHRA. Over 15 years of experience in working in CMC and regulatory affairs, including six years licensing medicines at the agency.
In his current position with Parexel, he has helped clients prepare their clinical trial, investigational new drug applications, MAAs, new drug applications, and variation submissions as a CMC subject matter expert. He has also provided regulatory, strategic, and technical input for regulator engagement and lifecycle activities in European and international markets.
Craig’s assessment work for MHRA entailed national and EU initial applications, which covered centralized, decentralized procedures, mutual recognition procedures, and new chemical entities. He also reviewed investigational medicinal product dossiers as part of clinical trial applications.

Craig was part of the 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. He has a pharmacy degree from Trinity College, Dublin and is a registered pharmacist in Ireland.
Craig is a RAPS member and has contributed content on regulatory strategy and quality management systems to RAPS publications, as well as to the society’s Fundamentals of EU Regulatory Affairs (8th ed.). He is currently on the planning committee for RAPS Euro Convergence.

Presentation(s):

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