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. D’Cunha is the Director, Global Medical Affairs at Apotex Inc. responsible for Medical Affairs activities within the group. Prior responsibilities included Pharmacovigilance. He has over 16 years experience in public health at both the local and provincial levels of government. He has held senior positions including Chief Medical Officer of Health, Commissioner of Public Health and Assistant Deputy Minister, Ontario, Chief Occupational Medical Officer, Manitoba and Medical Officer of Health, Scarborough. He has actively participated in national population health matters. Dr. D'Cunha graduated in medicine from the University of Bombay, and obtained his Masters of Health Science from the University of Toronto.

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.

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Dr. Raleigh Malik is a Sr. Scientist at DIA in Washington, DC, where she supports the advancement of DIA’s global content strategy by providing scientific expertise related to therapeutic drug development and regulatory disciplines. Prior to joining DIA, Dr. Malik supported medical and commercialization functions within pharma as both a medical writer and medical reviewer. Dr. Malik has a PhD in Molecular Biology and Biochemistry from Indiana University School of Medicine and a BS in Cell Biology and Biochemistry from Bucknell University.

Dr. Hadj-Omar is Director, Global Medical Safety at Pharmascience Inc. responsible for managing the local and international PV operations, Risk Management Plans, signal detection, benefit-risk assessment and other PV activities. Maha's experience spans over 15 years in drug safety within both Global and Canadian-based pharmaceutical corporations. She is trained as a medical doctor, specialised in medical microbiology from Algiers. Maha completed a master’s degree in Drug Development - Clinical Research from Université de Montréal.

Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has been a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within the Marketed Health Product Directorate (MHPD), as well as a member of the core team for the Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Since 2018 she has held the position of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate.

Agnes is an industry leader with over twenty years of experience in pharmacovigilance (PV) and medical information (MI) both in the pharmaceutical industry as well as in the consulting environment. She is a Vice President of Pharmacovigilance at Veristat, a CRO whose team includes experienced and dedicated PV professionals. Agnes in an expert PV auditor and a recognized pharmacovigilance educator engaged in teaching pharmacovigilance courses and presenting on various PV topics. Agnes holds a graduate degree in Pharmacology & Toxicology and, prior to joining the pharmaceutical industry, was involved in academic research.

Sophie Lafrance has worked in federal regulations since 2005 when she joined Health Canada’s Health Products and Food Branch Inspectorate (now known as the Health Product Compliance Directorate, RORB). She is the national coordinator of the Good Pharmacovigilance Practices (GVP) inspection program since 2008. Her role is to support the delivery of Canada’s national GVP inspection program by providing support to inspectors for their inspections, assisting in resolving emerging issues arising from these inspections, liaising with the Marketed Health Products Directorate (MHPD), and contributing to the development of program regulations, policies, and guidelines.

Anne has practiced exclusively in the area of Regulatory Affairs in Canada since 1971. She has worked for three pharmaceutical companies: Wyeth, Roche and Searle. She started the regulatory consulting company, CanReg Inc, that was later sold to a US company. After working with the purchaser for 4 years, Anne set up her current regulatory consulting company, Therapeutic Products Inc. (TPIreg), which provides regulatory consulting in Canada and the US, including eCTD publishing. TPIreg also provides QA services in Canada and the US and holds and Establishment Licence with Health Canada as an importer. Anne operates out of Hamilton, Ontario.

She holds a Master’s Degree in Pharmacy, an adult teaching certification and is currently the Head of Drug Safety and Medical Information at Purdue Canada. Adriana is adult teaching certified and taught a college level pharmacology course and lectured at schools of pharmacy. At Baxter, Wyeth and Forest, Adriana developed a broad range of knowledge and expertise in Canadian and international safety and GMP regulations and led a number of innovative changes. In her current role at Purdue, Adriana is tasked with the ongoing assessment and monitoring of safety compliance and signals, the development of safety data exchange agreements, and the management of medical information.

Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTM, Stella studied medicine at Cambridge and Guys, working in hospital medicine before joining the pharma industry. She has worked in PhV and pharmacoepi for 35 years: in industry (11+ years) as a regulator (16+ years) and CRO (9 years). Following her MSc in Epidemiology from LSHTM, she co-developed their course in PhV and Pharmacoepi. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU strategy and policy on risk management, was lead writer on the EU guidelines on this and was part of the core team implementing the 2010 PhV legislation and ENCePP. She is/was on the CIOMS IX/XI/XIII working parties and is a member of the CIOMS Executive Committee.

Sarah Clayman joined Health Canada in 2005. She holds a Bachelor of Science and a Bachelor of Education from the University of Ottawa. She has previously worked in the international division of the Health Products and Food Branch. In 2013, she joined the Marketed Health Products Directorate and is currently the managing editor of the Health Product InfoWatch, a monthly Health Canada publication highlighting health product safety information. She is also working on the development of regulatory guidelines.

Sophie Sommerer is the Director General of Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate. She is responsible for regulating biologic drugs (including vaccines), radiopharmaceuticals, blood, cells, tissues and organs, and products for Assisted Human Reproduction. Prior to this, she held various positions in the Marketed Health Products Directorate, where she oversaw pharmacovigilance and risk management activities of medical, scientific and regulatory experts. She spent the first 10 years of her public service career working on various health promotion policy initiatives at the Public Health Agency of Canada.

Eileen Tan provides legal support to many of Apotex’s business functions, including its Global Pharmacovigilance and Global Medical Affairs teams. She also handles all privacy matters for the Apotex group of companies. Eileen was admitted to the Ontario bar in 2011, and holds a J.D. from York University’s Osgoode Hall Law School, as well as a BBA from Wilfrid Laurier University.

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.

Bruce Wozny has been a senior policy officer with the Marketed Health Products Directorate of Health Canada since 2002. Before that he worked in compliance and enforcement of the Food and Drugs Act and Regulations. He is currently working on vigilance policy, including the development of regulations and guidelines for Risk Management Plans and other vigilance tools and activities.