This very well received and timely roundtable discussion was moderated by Advera Health, and focused on how COVID-19 is affecting pharmacovigilance reporting, intake, and evaluation. The roundtable lasted approximately 50 minutes, with 10 minutes for audience Q&A at the end.
Topic 1: On the Front Lines: How COVID-19 will affect post-marketing reporting
Topic 2: How case intake and processing are effected by remote work and reduced staff
Topic 3: Best practices to ensure signal detection and management does not stop because of COVID-19
Catherine is the Principal Consultant and Owner of Essential Pharmacovigilance, a company dedicated to providing expert consultancy, training, and services for companies who need assistance with their Clinical Safety & Pharmacovigilance activities. She is also a Professor of Pharmacovigilance at Temple University, a current member of the Community Leadership Council and the former chair of DIA Clinical Safety and Pharmacovigilance Community.
Dr. Siva is an ER Physician by education. He currently works as a subject matter expert and Safety Physician at Indegene, a company that enables global healthcare organizations to address complex challenges and drive better health and business outcomes. Dr. Siva is responsible for client engagement, project delivery, and strategy for Indegene’s pharmacovigilance engagements. He has been in the forefront in development of various PV automation tools within Indegene, has played a back-up QPPV role, and has reviewed signals for the India Pharmacovigilance Program.
Dr. Doraiswamy is a physician and highly cited clinical trials and pharmacovigilance researcher at Duke University School of Medicine where he serves as Professor of Psychiatry and Medicine. He has been a principal investigator on many landmark outcomes studies of drugs, devices and diagnostics, and is the co-author of over 300 publications. Murali has served as an advisor to leading government agencies (such as the NIH, FDA and WHO), pharmaceutical companies and patient advocacy groups. He is a member of the World Economic Forum’s Global Future Councils and a scientific advisor to Advera Health.
Suneet is CEO and Founder of Soterius, a company that provides global safety, medical affairs, regulatory, and technology enabled solutions. Suneet is a business leader and entrepreneur with more than 25 years of operations, technology, and finance experience in the healthcare/pharmaceuticals space. Prior to starting Soterius, Suneet founded and built the business for a global safety services provider.
Dr. Weiss is the President and Founder of Avigilan, a small boutique consultancy that provides scientific and regulatory expertise and services that are required to identify, quantify, evaluate, articulate, and manage risks of regulated products. Prior to Avigilan, Dr. Weiss was Professor and Director of the Center for Drug Safety at the University of Maryland Baltimore. Prior to joining the University faculty, Sheila worked at the FDA in what is now the Office of Surveillance and Epidemiology (OSE), CDER