Speakers
Mwango Kashoki, MD, MPH
Vice President, Technical, Parexel, United States
Mwango draws on over 16 years of drug review, development and regulatory experience at FDA, with proven expertise in development of analgesic and addiction (alcohol and opioid) therapies, as well as in post-approval activities including, pharmacovigilance, risk management, and Phase 4 studies. Mwango has strong knowledge of review and development of small molecules and biologics, OTC products, and generics.
Cindy Kortepeter, PharmD
Director, Division of Pharmacovigilance I, OSE, CDER, FDA, United States
Gary H. Slatko, MD
Director, Office of Medication Error Prevention and Risk Management, OSE, CDER , FDA , United States
Gary Slatko, MD directs the Office of Medication Error Prevention and Risk Management at FDA, which is responsible for the review and approval of all REMS programs and the prevention of human factor-related medication errors. He previously served as CMO of ParagonRx, a drug safety consulting firm, and has had 15 years of pharmaceutical industry experience in drug safety, medical affairs, disease management and product planning. He holds a MD degree from Univ of Miami and MBA from W Chester Univ.
Laura Pincock, PharmD, MPH
Health Communications and Education Specialist, OTBB, OND, CDER, FDA, United States
Min Chen, MS, RPh
Acting Director, Division of Pharmacovigilance I, OSE, CDER, FDA, United States
Patrick Archdeacon, MD
Medical Officer, Division of Medical Policy Development, OMP, CDER, FDA, United States
Theresa A. Toigo, MBA, RPh
Associate Director for Drug Safety Operations, OCD, CDER, FDA, United States
Theresa (Terry) Toigo, Associate Director for Drug Safety Operations, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). She is responsible for the creation and oversight of CDER processes for management of cross-Office and cross-Center safety projects, including REMS.
Sally M. Seymour, MD
Deputy Director of Safety/DPARP/OND/CDER, FDA, United States
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