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Canadian Pharmacovigilance and Risk Management Conference

This event is now offered in a new entirely virtual format.


Speakers

  • Rita  Cassola, RPh

    Rita Cassola, RPh

    • Executive Director PV
    • Certus PV Services Inc, Canada

    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.

  • Marcia  Bailey, BSN, MHS, RN

    Marcia Bailey, BSN, MHS, RN

    • Senior Manager, Pharmacovigilance
    • Sierra Oncology , Canada

    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 Senior Manager in Pharmacovigilance at Sierra Oncology.

  • Marc  Poitras, PhD, MBA

    Marc Poitras, PhD, MBA

    • Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
    • Health Canada, Canada

    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.

  • Sophie  Sommerer, MS

    Sophie Sommerer, MS

    • Director
    • Health Canada, Canada

    Sophie Sommerer is currently the Acting Director General of the Marketed Health Products Directorate at Health Canada, where she is responsible for overseeing pharmacovigilance and risk management activities for a range of marketed health products. Previously, she held positions as Director of the Marketed Health Products Safety and Effectiveness Information Bureau and as Acting Director and Associate Director of the Bureau of Cardiology, Allergy and Neurological Sciences, following over 10 years working primarily in health promotion policy at the Public Health Agency of Canada. Sophie has a Bachelor of Science (Honours) in Biology from Queen’s University and a Master of Science in Biology from Carleton University.

  • Bruce  Valliant

    Bruce Valliant

    • Head of Pharmacovigilance and Medical Information
    • Pharmascience Inc., Canada

    Bruce began his career in the pharmaceutical industry over 30 years ago. He has worked in senior management positions for 4 different multi-national brand name companies over a span of approximately 20 years as head of departments in Canada for Regulatory Affairs, Quality Assurance, Clinical Quality Assurance, Pharmacovigilance and Medical Information (at times with various combinations of these responsibilities concurrently). More recently between 2008 and 2018, he was worked in the generic drug industry for Teva Canada Limited as the head of clinical research, pharmacovigilance and medical affairs. Since 2018, he has worked for Pharmascience Inc. in their Montreal head office as Head of Pharmacovigilance and Medical Information.

  • Deborah  Danoff, MD, FRCP

    Deborah Danoff, MD, FRCP

    • Medical Evaluator
    • Health Canada, Canada

    Dr. Danoff is a medical officer in the Marketed Health Products Directorate at Health Canada. Her current focus is post marketing surveillance for biologics including vaccines. She received her medical degree from McGill University Faculty of Medicine and completed specialty training in Internal Medicine and Clinical Immunology and Allergy at McGill. Her clinical practice focused on patients with complex allergy problems or autoimmune diseases. Her research focus included autoimmune diseases and issues related to medical education.

  • Bruce  Wozny, MA

    Bruce Wozny, MA

    • Sr. Policy Officer
    • Health Canada, Canada

    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.

  • Stéphane  Bérard, MS

    Stéphane Bérard, MS

    • Regional Regulatory Compliance and Enforcement Specialist
    • Health Canada, Canada

    Stéphane has been working as inspector for the Regulatory Operations and Enforcement Branch (ROEB) at Health Canada since 2012. Up to this day, he has conducted various compliance verifications and pharmacovigilance inspections. In 2017, Stéphane was promoted to the position of inspector-specialist. As part of this role, he is responsible for collaborating in the Health Canada’s GVP Program Review as well as training new inspectors, planning and assigning inspections. Before joining Health Canada, Stéphane worked approximately 10 years for the pharmaceutical industry in quality assurance and as Project Manager-biologics in pharmaceutical development. He holds a M.Sc. in biology with a focus on virology and cell biology.

  • Eian  Elliott, MBA

    Eian Elliott, MBA

    • Senior Corporate Regulatory Compliance & Enforcement Advisor
    • Health Canada, Canada

    Eian spent 20 years in the pharmaceutical industry in a manufacturing setting which included managerial roles in materials management and quality control. He has spent the last ten years with Health Canada, currently as a Senior Corporate Regulatory Compliance and Enforcement Advisor with the Health Products Compliance Directorate of the Regulatory Operations and Enforcement Branch.

  • Georgy  Genov, MD

    Georgy Genov, MD

    • Head of Pharmacovigilance Office, Quality and Safety of Medicines Department
    • European Medicines Agency, Netherlands

    Dr Georgy Genov is qualified as medical practitioner. He joined the pharmaceutical industry in 1998. Since then he has gained experience in Drug Development, Medical Affairs and Pharmacovigilance. In 2010, he joined the Pharmacovigilance and Risk Management team of the European Medicines Agency. In 2011 Dr Genov was appointed Head of Signal and Incident Management Office. At the beginning of 2020 he assumed the role of Head of Pharmacovigilance.

  • Robert  Pawinski, MEd, MHA, MSN

    Robert Pawinski, MEd, MHA, MSN

    • Chief Medical Officer
    • R&R Executive Consulting, United Kingdom

    Dr Robert Pawinski is an experienced global pharmaceutical physician with experience from drug development to post-marketing, in small, medium and big pharma, as medical director and QPPV. Robert has worked with medical cannabis industry partners helping organisations develop clinical trial strategies, setting up registries, and developing and implementing pharmacovigilance systems in global markets.

  • Gerald J. Dal Pan, MD, MHS

    Gerald J. Dal Pan, MD, MHS

    • Director, Office of Surveillance and Epidemiology, CDER
    • FDA, United States

    Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the WHO Advisory Committee on the Safety of Medicinal Products, he served on the Council of International Organization of Medical Sciences and the International Council on Harmonisation. He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. Before joining FDA, he was a faculty member in Neurology at Johns Hopkins.

  • Bruce  Gordon, MSc

    Bruce Gordon, MSc

    • Senior Evaluator
    • Health Canada, Canada

    Bruce Gordon has been a scientific evaluator with the Marketed Health Products Directorate (MHPD) at Health Canada since 2001. He has a background in molecular biology, and significant experience in the post-market safety review of biologic products, including recombinant biotherapeutics and blood products. Over the past 19 years, he has led multiple high-profile safety reviews that resulted in regulatory actions as well as numerous risk communications. More recently, he has had important policy and process development roles in the MHPD, including leading the development and implementation of a new signal detection working group to evaluate all company-submitted Periodic Benefit-Risk Evaluation Reports (PBRERs) for biologics.

  • Rania  Mouchantaf, PhD

    Rania Mouchantaf, PhD

    • Associate Director
    • Health Canada, Canada

    Dr. Rania Mouchantaf has over 10 years of experience in the area of pharmacovigilance and drug safety. Her career at Health Canada has spanned a number of roles in assessment, management and strategic policy development such as the implementation of the risk management planning process in Canada and regulatory modernization of other various pre and post-market processes. Before entering the government Dr. Mouchantaf worked in the area of business development at Paladin labs in Montreal. Her education includes a Bachelor degree in Microbiology and Immunology and a doctorate degree in Pharmacology and Therapeutics from McGill University.

  • Bernard  Ogbiti, DrMed

    Bernard Ogbiti, DrMed

    • Pharmacovigilance and Medical Information Associate II - Qualified Health Care P
    • NONE, Canada

    Doctor of Medicine Bachelor of Science (Neuroscience, Integrative Biology and Psychology) Professional Certification in: Project Management, Business strategy, Macroeconomics and FDA Prescription Drug Regulation, Cost, and Access. Pharmacovigilance and Medical Information Associate 2-Qualified Health Care Professional with vast experience in Individual Case Safety Report Processing, Aggregate Reports, including critical analysis and medical conclusion, Screening of and processing the Canada Vigilance adverse reaction online database

  • Ruben  Ayzin Rosoky, MD, PhD

    Ruben Ayzin Rosoky, MD, PhD

    • Sr Safety Physician
    • United Biosource Corp., France

    Ruben Ayzin Rosoky is a Senior Safety Physician with UBC since 2010. He has 16+ years of experience in the Pharmaceutical Industry, 22+ years of experience in medical practice in Vascular Medicine, and 18 years of experience in academic research. During his entire career in the Pharmaceutical Industry, Ruben has been involved in several different activities inherent to pharmacovigilance and drug safety. Some of those relate to risk management and signal management. He is an expert in data mining for signal detection, in signal assessment of complex safety concerns, and in the assessment and management of the benefit-risk balance of pharmaceutical products.

  • Gayatri  Jayaraman, PhD, MPH

    Gayatri Jayaraman, PhD, MPH

    • Director, Marketed Health Products Directorate
    • Health Canada, Canada

    Dr. Gayatri Jayaraman is the Director, Marketed Health Products Directorate at Health Canada. Prior to joining the federal government, she worked as a Public Health Program Consultant in East Africa, South Asia, and the Balkans. She is an adjunct professor in the School of Epidemiology and Public Health at the University of Ottawa. Dr. Jayaraman has co-authored over 100 publications is the proud recipient of the Public Health Agency of Canada’s Dr. Andres Petrasovits Award for Excellence in Public Health. She holds a PhD in Microbiology and Immunology from the University of Rochester, NY and a Master's of Public Health (Epidemiology/Health Policy) from Johns Hopkins University, Maryland.

  • Chanez Narimene  Kebache, MBA

    Chanez Narimene Kebache, MBA

    • Director, Global Product Safety & Pharmacovigilance
    • Canopy Growth Corporation, Canada

    Chanez is lead for global Pharmacovigilance at Canopy Growth, the world’s largest cannabis company. With over 15 years of experience in Global and Canadian PV, she holds a bachelor’s degree in microbiology and immunology from Université de Montréal and a MBA from HEC Montréal. Chanez started her career at ratiopharm Inc. and Axcan Pharma; she later joined Mallinckrodt Pharmaceuticals as head of Canadian PV where she also led global integration and migration projects. Chanez co-chaired the Canadian Annual DIA meeting in 2013 and remained a contributor for several years.

  • Kelly  Robinson, MSc

    Kelly Robinson, MSc

    • Director General, Marketed Health Products Directorate
    • Health Canada, Canada

    Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market review and regulation of biologics and pharmaceuticals. Kelly has been involved in initiatives such as international work sharing, HTA alignment and policy related to submissions relying on third party data. Kelly has recently rejoined the Marketed Health Products Directorate as the Director General.

  • Heidi  Levens, MSc

    Heidi Levens, MSc

    • Head of Canada, Patient Safety
    • Bristol-Myers Squibb Company, Canada

    Heidi holds an MSc in Pharmacovigilance and has worked in the pharmaceutical industry for over 30 years. She started her early research career specializing in organic chemistry, and later transitioned into Pharmacovigilance in 2001. Heidi has held pharmacovigilance roles of increasing responsibility since that time. She has worked at BMS for 11 years in the roles of Senior Pharmacovigilance Associate, Documentation Manager, Global Safety Risk Management and most recently as the local safety officer, Head of Canada, Patient Safety, overseeing all local safety responsibilities for the Canadian affiliate.

  • Janine  Collins, MD, LLM

    Janine Collins, MD, LLM

    • Executive Director Safety, Epidemiology , Registries and Risk Management
    • United BioSource Corporation, Switzerland

    Dr Janine Collins is a graduate of St. George’s Hospital Medical School, London and obtained a Master’s Degree in Legal Aspects of Medical Practice from Cardiff Law School. Along with16 years of clinical practice, she has more than 19 years of industry experience in Drug Safety, Risk Management, Medical Affairs and Clinical Research. Dr Collins is Executive Director of Safety, Epidemiology, Registries and Risk Management at UBC where she provides consultant services focusing on Risk Management including the associated activities such as post approval safety studies, educational programs for risk minimization and assessment the effectiveness of risk minimization. She has extensive experience in both the European Union and Canada.

  • Fannie  St-Gelais, PhD

    Fannie St-Gelais, PhD

    • Senior Drug Reviewer,CNSD-DSNC, HPFB
    • Health Canada, Canada

    Fannie has been with Health Canada for the past 12 years. She has held various positions in the medical device and drug areas, both as reviewer and manager, in pre- and post-market settings. Fannie is currently a Senior Reviewer in the central nervous system division of the Therapeutic Products Directorate. She represents Health Canada on the ICH E19 working group, currently preparing a new guidance document aimed at optimizing safety data collection. She holds a M.Sc. in Biophysics and a Ph.D. in Neurosciences from University of Montreal and completed her post-doctoral training at Yale University.