Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Veronika Jekerle joined the European Medicines Agency in 2006. She has been a Product Team Leader for numerous Biological medicinal products applications including Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. In 2014 she became a Quality Specialist within the...
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Senior Assessor Biopharmaceuticals, Medicines Evaluation Board
Marcel Hoefnagel is an expert in Biopharmaceuticals working as Senior assessor for the Medicines Evaluation Board (CBG-MEB) the Netherlands. Since 2002 he is a regulator CMC of biopharmaceuticals (registration, GMP and legal aspects) as specialist in vaccines, allergens, biosimilars...
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Chemist, OLDP, OPQ, CDER, FDA, United States
Dr. Fang Yuan received her Ph.D. degree in Pharmaceutical Science from University of Nebraska Medical Center. She has been a Chemist in Office of Lifecycle Drug Product since 2016, with expertise in quality assessments of pre-market ANDA submissions and pre-ANDA submissions of complex...
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Regulatory Program Director, Genentech, A Member of the Roche Group, United States
Lisa deCardenas is a Regulatory Program Director at Genentech, A Member of the Roche Group in South San Francisco, California. She is a CMC regulatory affairs professional with 19 years of industry experience in biologics development, including global registration of Clinical Trials...
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Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees...
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Quality Specialist - Pharmaceutical Quality Office, European Medicines Agency, Netherlands
Dolores obtained a Pharmacy degree and a European PhD in Pharmaceutical Technology from the Complutense University, conducting research stays at Virginia Commonwealth University, USA and the Italian National Research Council. She joined the Quality Office of the EMA in 2010, first...
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Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States
Laurie Graham is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER). DIPAP is responsible for...
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