Associate Director Global CMC Policy, Merck & Co., Inc., United States
Mic currently is an Associate Director of Global CMC Policy at Merck. He has over 27 years experience with Vaccine and Biologics. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, post approval submissions globally, and evaluation of worldwide guidance's...
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Executive Director, Regulatory CMC, Pharmtree Consultants, LLC
Terry established PharmTree Consultants, LLC, to help bio and pharma companies develop strong regulatory strategies and submissions. He served as a reviewer and Division Director at FDA, worked as a pharmacist and developed and manufactured most types of dosage forms, including combination...
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EMA Official at the FDA, European Medicines Agency
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product...
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