Marcia is a registered nurse with many years of clinical and industry experience. In addition to her past role as a clinical research data management subject matter expert, more than a decade of pharmacovigilance duties has helped Marcia acquire much of the knowledge, skills, and abilities needed to help companies manage today’s evolving drug safety responsibilities and regulations. Marcia has been a DIA conference speaker and is currently a Safety Evaluation & Risk Management Scientific Director at GSK.

Rita Cassola is an Executive Director of Pharmacovigilance at Certus PV Services Inc. Rita is a registered pharmacist with over 20 years of experience in global and Canadian pharmacovigilance. Rita’s experience includes over 10 years of senior PV consultancy and 10 years in increasingly senior PV roles within the pharmaceutical industry. Prior to joining the pharmaceutical industry, Rita spent 4 years in academia and 10 years in hospital pharmacy. Rita is engaged in teaching pharmacovigilance courses and has presented at several conferences/webinars organized by professional associations.

Dr. Poitras has worked at Health Canada in different capacities in Pharmacovigilance and drug safety for the last 13 years. His undergraduate and graduate training includes a BSc in Biotechnology and MSc/PhD degrees in Pharmacology from the University of Sherbrooke. He also completed post-doctoral training programs in cellular biology and neuroscience at Johns Hopkins University and New York University. He then completed a MBA at the University of Ottawa. Dr. Poitras is currently working as a Scientific Manager at the Marketed Health Products Directorate.

Melanie Derry is the associate director of the Marketed Biologicals, Biotechnology and Natural Health Products Bureau at Health Canada, a bureau responsible for post-market surveillance and risk management. With more than a decade of experience as a scientific evaluator, Melanie now helps support the operations, planning, finance, staffing, and scientific activities of the bureau. Among these roles, she also participates in planning and implementation of new processes and policies for the bureau, and is active in identifying opportunities for greater collaboration among various groups within Health Canada, as well as with key external stakeholders.

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

Paul Litowitz began working for Health Canada in 2008. He manages a public and regulatory affairs outreach team within the Canada Vigilance Program at the Marketed Health Products Directorate. Among other responsibilities, Paul oversees guidance for industry and hospitals concerning adverse reaction reporting regulations for marketed health products. Paul holds a Bachelor of Science from the University of Guelph, a post-diploma in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College, and a Master of Business Administration from the University of Windsor.

Fannie has been with Health Canada for the past 18 years. She has held various positions in the medical device and drug areas, both as a reviewer and a manager, in premarket evaluation and pharmacovigilance. She has represented Health Canada on the ICH E19 working group. She holds a M.Sc. in Biophysics and a Ph.D. in Neurosciences from the University of Montreal and completed her post-doctoral training at Yale University. She currently is a manager in the Human Safety Division of the Veterinary Drug Directorate.

Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring the safety of patients worldwide. Jeremy has led numerous cross-industry pharmacovigilance workgroups and initiatives for DIA, TransCelerate, and ICH, and is a frequent speaker at industry conferences. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, medical device, and patient safety research. He holds MS and PhD degrees in quantitative psychology from Ohio University

Gautamdeep kaur is currently working as a Pharmacovigilance and Medical Information Manager with Certus PV Services. She has a degree in Bachelor of Dental Surgery and a vast experience in Pharmacovigilance spanning over 6 years.

Marc Mes is the Director General of the Marketed Health Products Directorate in the Health Products and Food Branch of Health Canada. He is responsible for the oversight of the vigilance of marketed health products in Canada including ensuring Canadians and health professionals are informed of important issues impacting the safety and effectiveness of health products in a timely fashion. Following a career in teaching, Marc began his federal public service career with the Department of Foreign Affairs and International Trade in 2002. He subsequently held positions in Marine Security Policy and Operations at Transport Canada with areas of responsibility including national and international marine security files and inspection and enforceme

Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World Evidence, including managing the Sentinel System.

Dr Catherine Godefroy is a pharmacist with 18+ years’ experience in pharmacovigilance and patient safety. She provides strategic input into global and local risk management strategies including but not limited to US, Europe and Canada. Dr Godefroy participated in pre-submission meetings with the FDA, EMA, and Health Canada. She led global safety teams in small and larger pharmaceutical companies through mergers and acquisitions. She received her master's degree in biological and medical sciences and her doctor of pharmacy from the University of Angers in France. She also holds a postgraduate Diploma in Drug Development with a specialization in pharmacoeconomy and pharmacopidemiology from the University of Montreal, Canada.

Laura Meaney is the Manager for the Data Management and Integrity Section at the Marketed Health Products Directorate. Laura has been a member of the Public Service of Canada since 2008 and has worked in the Therapeutic Products Directorate, the Regulatory, Operations and Enforcement Branch and now the Marketed Health Products Directorate at Health Canada. Laura graduated from the University of Ottawa with a Bachelor of Science in Biopharmaceutical Science.