Senior Science Advisor for CMC, Office of the Center Director, CBER, FDA, United States
Ingrid Markovic, Ph.D. serves as the CMC Policy Lead in the CBER Office of the Center Director where she spearheads CMC Policy activities partnering with internal and external stakeholders to ensure consistent interpretation and application of CMC policies and programs. In the international...
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Senior Director, Technical and Strategic Area Lead, Plasma, GRA CMC, CSL Behring GmbH, Germany
After obtaining his Diploma in Chemistry Dieter Brazel has earned a Ph.D. from Stuttgart University (thesis Max Planck Institute for Biochemistry). Further he holds a Masters in Regulatory Affairs in Regulatory Affairs University of Bonn. He has spent his entire career in the biopharmaceutical...
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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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Associate Director for Biosimilar& Regulatory Strategy, OBP, OPQ, CDER, FDA, United States
Joel Welch is the Associate Director for Biosimilar & Strategy in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies...
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