Instructors
Sanjay K Sahoo
Associate Director, Tools, Technology, and Innovation, OCS, OTS, CDER, FDA, United States
Sanjay K. Sahoo MS. MBA. Food and Drug Administration. FAERS Expert and Business Owner, Regulatory Science, OSE/CDER/FDA Mr. Sanjay K. Sahoo has over 18 years of demonstrated achievements, across FDA, NIH, and Bio-Pharma companies, impacting public safety through alignment of policies, regulations and innovative healthcare informatics solutions with strategic objectives. Now in Office of Surveillance and Epidemiology at CDER, Mr. Sanjay as FDA Adverse Events System (FAERS) expert and business owner provides expert advice and technical direction on regulatory science of exploring and developing new tools, data sources, standards, methods and approaches to assess safety, efficacy, quality, and performances of all FDA-regulated products.
Sonja Brajovic, MD
Medical Officer, OSE, CDER , FDA, United States
Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities (MedDRA), including monitoring MedDRA coding quality of reports in the FDA Adverse Event Reporting System (FAERS). Sonja represents FDA on the International Conference on Harmonisation (ICH) MedDRA Points to Consider workgroup. Sonja obtained her medical degree in the former Yugoslavia.
Judy Harrison, MD
Chief Medical Officer, United States
Dr. Harrison is the Chief Medical Officer of the MedDRA Maintenance and Support Services Organization (MSSO) where she is responsible for overall medical strategy. She has over 25 years’ experience in clinical research and pharmacovigilance, and is a member of the ICH M1 “Points to Consider” Working Group and the CIOMS Implementation Working Group on Standardised MedDRA Queries (SMQs).
Jo Wyeth, PHARMD
Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER, FDA, United States
Jo Wyeth is the Associate Director for Postmarket Assessments, serving as a senior-level scientist specializing in the application of risk management principles and leading efforts to implement and oversee medication error pharmacovigilance activities, research and quality assurance activities, and assessment of risk mitigation measures. She also performs complex safety analyses, advises Office and Division management, and provides leadership for planning, program development, policy and program analysis, and the implementation of safety initiatives that support OMEPRM.