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DIA Annual Canadian Meeting

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


Speakers

  • Marc F. Poitras, PhD, MBA

    Marc F. 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 12 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.

  • Lisa  Chartrand

    Lisa Chartrand

    • Director, Regulatory Strategy and Policy
    • Hoffmann-La Roche Limited, Canada

    Lisa Chartrand began her career in the industry with Apotex as a quality assurance chemist and found her passion in Regulatory Affairs when she joined EMD Serono in 1999. At Roche Canada since 2003, she has enjoyed many growth opportunities in Regulatory Affairs and Medical Affairs and was appointed Director, Regulatory Affairs in 2014. Lisa is co-chair and an active member of Innovative Medicines Canada's Regulatory Operations Team and a member of BioteCanada's Biologics Regulatory Affairs Group (BRAG). Lisa earned her Bachelors of Science in Microbiology and Immunology from McGill University in Montreal, Quebec and holds a certificate from TIPT in Quality Assurance.

  • Samar  Darwish, MBA, MSc

    Samar Darwish, MBA, MSc

    • Director,Drug Regulatory Affairs
    • Boehringer Ingelheim Canada, Canada

    Samar began her career in basic research in private and hospital settings, and is currently the Director of Regulatory Affairs at Boehringer-Ingelheim (Canada) Ltd., a global family owned Pharmaceutical Company. Samar’s proficiency includes over 25 years of experience in progressive roles in basic research and the Pharmaceutical Industry, with more than 18 years of proven strategic leadership and people management skills, motivating various teams in different functions to deliver high quality results in line with business priorities. She graduated from the University of Western Ontario with a M.SC. in Molecular Biology, and most recently completed her Executive MBA from the Ivey Business School in London Ontario.

  • Judith  Mergl, MSc

    Judith Mergl, MSc

    • Director, Regulatory Affairs & Operational Services
    • Abbvie Corporation, Canada

    Over her 28-year career with Abbott/AbbVie, Judith has held various roles of increasing responsibility. She currently leads a team of Regulatory Affairs professionals focused on biopharmaceutical drug submissions for clinical development and commercial products in the areas of Immunology, Oncology, Virology, Neuroscience, Hormone Replacement Therapy, and Specialty Care. Judith also has general oversight of the Quality Assurance and Logistics teams and is an active member of BIOTECanada’s Biologics Regulatory Affairs Group (BRAG). Judith holds a Master’s Degree in Toxicology from Université de Montréal and a Bachelor’s Degree in Biochemistry (Specialty in Medicinal Chemistry) from Concordia University.

  • Melissa  Hunt, MSc

    Melissa Hunt, MSc

    • Director
    • Health Canada, Canada

    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 to working at Health Canada, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has worked as a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within MHPD, as well as on the core team Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Most recently she has taken a position as the Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Therapeutic Products Directorate.

  • Yatika  Kohli, PhD, MBA

    Yatika Kohli, PhD, MBA

    • Executive Director - Global Regulatory Affairs
    • NoNO Inc, Canada

    Dr. Yatika Kohli is an accomplished Senior Regulatory Professional with strong leadership skills, strategic foresight and business acumen. At NoNO Inc, Dr. Kohli is leading all strategic and global regulatory initiatives for NoNO’s products. With more than 20 years of experience in Biotech/Pharmaceutical industry, Dr. Kohli has expertise in developing global regulatory and clinical strategy with project and product management across multiple modalities and jurisdictions. She led the regulatory activities for the registration and launch of two blockbuster vaccines for Sanofi Pasteur in the USA and Apotex’s first biosimilar product in Europe.

  • Lorella  Garofalo, PhD

    Lorella Garofalo, PhD

    • Director, Regulatory Affairs Canada; Global Regulatory Affairs International
    • Pfizer Canada ULC, Canada

    Lorella has been with Pfizer Canada since 2001 assuming roles of increasing responsibility in clinical research as well as medical affairs and is currently head of regulatory affairs for Pfizer Canada. She obtained a BSc (Honours) in Biochemistry and a PhD in Pharmacology & Therapeutics from McGill University. Prior to joining Pfizer, Lorella was a drug assessment officer at TPD, Health Canada and since 1999 has maintained an academic appointment with the department of Pharmacology & Therapeutics at McGill. She has served as a member of the board of directors/advisory councils for various research organizations and is a member of the regulatory affairs committees of Innovative Medicines Canada and BIOTECanada.

  • Kristin  Willemsen, MS

    Kristin Willemsen, MS

    • Director of Scientific & Regulatory Affairs
    • Consumer Health Products Canada, Canada

    Kristin Willemsen is the Director of Scientific and Regulatory Affairs for Consumer Health Products Canada. Since 2008, she has been working with members to influence the regulation, policy and administration of over-the-counter drugs and natural health products. Kristin earned a Masters of Science from the University of Ottawa and is a Certified Association Executive.

  • Fiona M Frappier, PhD

    Fiona M Frappier, PhD

    • Senior Policy Analyst
    • Health Canada, Canada

    Fiona Frappier is a Senior Policy Analyst in the Office of Policy and International Collaboration at the Biologics and Genetic Therapies Directorate of the Health Products Food Branch at Health Canada. She has a PhD in HIV Immunology and 10 years of experience on multi-jurisdictional policy issues including rare diseases, genomics and antimicrobial resistance.

  • 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.

  • Tharany  Ganesh

    Tharany Ganesh

    • Director, Regulatory Affairs & Quality Assurance
    • AstraZeneca Canada Inc., Canada

    Tharany Ganesh has been with AstraZeneca since 2006, holding progressive roles in Regulatory Affairs and Quality Assurance. She has worked in several different therapy areas including Oncology, Cardiovascular, Respiratory, Gastrointestinal and Neuroscience during her career at AstraZeneca and is the current Director of Regulatory Affairs and Quality Assurance. Tharany holds a Master of Biotechnology degree from the University of Toronto, and an Honours Bachelor of Science degree from the University of Waterloo.

  • Gary  Condran

    Gary Condran

    • Manager, Generic Drugs Quality Division, Bureau of Pharmaceutical Sciences, TPD
    • Health Canada, Canada

    After being employed for several years in the Regulatory Affairs Departments of two multi-national pharmaceutical companies in the Toronto area, Gary Condran re-joined Health Canada in 1995 as a Senior Quality Assessor. He has since progressed in several capacities within the department to his current position as Manager of the Generic Drugs Quality Division. He participates in a number of multi-lateral collaborative initiatives, including having represented Health Canada on ICH’s Q1A, Q3A, and Q3B Expert Working Groups. More recently, he fulfilled the role of Regulatory Chair of ICH’s Implementation Working Group for the Q11 Questions and Answers document.

  • Emile  Geoffroy, MS

    Emile Geoffroy, MS

    • Manager, Plannng, Performance and Stakeholder Engagement Division
    • Health Canada, Canada

    Emile is currently the manager of the Planning, Performance and Stakeholder Engagement division within the Therapeutic Products Directorate (TPD) of Health Canada. In addition, he is the Health Canada lead on the HTA alignment initiative. Emile has over 10 years of experience in regulatory affairs with TPD, in both the generic and innovative pre-market drug space. He has also worked in intellectual property with the Office of Patented Medicines and Liaison at Health Canada. Emile holds a master’s degree in neurobiology from McGill University.

  • Elizabeth  Toller, MA

    Elizabeth Toller, MA

    • Executive Director, Regulatory Innovation
    • Health Canada, Canada

    Elizabeth Toller is an experienced policy specialist and public sector leader with over eleven years’ experience working in the Government of Canada. Her passion for health issues and social policy has seen Elizabeth split her time in government between Health Canada, Immigration, Refugees and Citizenship Canada and the Privy Council Office. Elizabeth currently serves as the Executive Director for Regulatory Innovation in Health Canada’s Health Products and Food Branch, driving greater agility in Canada’s food and drug regulations to support enhanced safety and innovation. Outside of work, Elizabeth is a mother of two, active jogger, and garden enthusiast.

  • Marc  Lamoureux

    Marc Lamoureux

    • Manager, Digital Health Division, Medical Devices Directorate
    • Health Canada, Canada

    Marc has worked for Health Canada’s Medical Devices Directorate since 2011 specializing in the regulation of medical software, diagnostic imaging devices, and radiotherapy equipment. He is vice-chair of Canada’s Subcommittees for IEC TC62B and TC62C (Diagnostic Imaging and Radiotherapy) and is a co-chair of the International Medical Device Regulators Forum’s Cybersecurity Working Group. He is currently the lead for Health Canada’s Building Better Access to Digital Health Technologies initiative and is now the manager of the Digital Health Division within the Medical Devices Directorate at Health Canada.

  • Carole  Legare, MD

    Carole Legare, MD

    • Director, Office of Clinical Trials, TPD
    • Health Canada, Canada

    After gaining experience in clinical practice and public health, Dr Carole Légaré joined Health Canada in 2002 where she initially worked in pharmacovigilance. She also worked as a senior medical advisor for the Centre for Biologics Evaluation during the H1N1 influenza pandemic. In 2013, she joined the Therapeutic Products Directorate as the Director of the Office of Clinical Trials, where she oversees all activities related to the approval and pharmacovigilance of clinical trials involving pharmaceuticals as well as Health Canada’s Special Access Program. She is currently a member of the ICH E8 working group on General Considerations for Clinical Studies and the ICH E6 working group on Good Clinical Practice.

  • Lisa  Currie, MSc

    Lisa Currie, MSc

    • Acting Manager/Senior Epidemiologist
    • Health Canada, Canada

    Lisa Currie is a senior epidemiologist and the acting manager of the Epidemiology and Evidence Evaluation for Safety and Effectiveness Section within the Health Products Surveillance and Epidemiology Bureau of the Market Health Product Directorate at Health Canada. Prior to joining Health Canada, she was a clinical researcher in a variety of disciplines, including perinatal epidemiology, pediatric psychiatry and health systems research, as well as an occupational therapist in pediatrics and neonatology. Ms. Currie is currently completing a doctorate in epidemiology and holds degrees in neuroscience, occupational therapy, and community health & epidemiology.

  • Simon  Hagens

    Simon Hagens

    • Senior Director, Performance Analytics
    • Canada Health Infoway, Canada

  • Caroline  Healy, MSc

    Caroline Healy, MSc

    • Policy and International Coordination Advisor
    • Health Canada, Canada

    Caroline Healy is a Policy and International Coordination Advisor at Health Canada in the Health Products and Food Branch. She holds an MSc. in Biology, a certificate in Project Management, and completed a Graduate Diploma in Population Health Risk Assessment and Management from the University of Ottawa. She joined Health Canada in 2001 and has worked in various capacities within the Health Portfolio including research, project management, risk assessment and communications, emergency access to drugs under the Special Access Programme, policy and regulatory affairs.

  • Celia  Lourenco, PhD

    Celia Lourenco, PhD

    • Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB
    • Health Canada, Canada

    Celia Lourenco, PhD is the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia represents Health Canada at the Assembly and Management Committee of the International Council for Harmonization and at the Management Committee of the International Pharmaceutical Regulators Programme.

  • Pierre  Sabourin, MBA

    Pierre Sabourin, MBA

    • Assistant Deputy Minister, Health Products and Food Branch
    • Health Canada, Canada

    Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory authority for health products and food in Canada and internationally. Mr. Sabourin was the Senior Vice-President, at Canada Mortgage and Housing Corporation (CMHC) from 2013 – 2014. From 2010 to 2013, he held the position of Vice-President, Operations at Canada Border Services Agency. He also filled senior management positions up to Assistant Deputy Minister at the former Department of Foreign Affairs and International Trade.

  • Dianne  Spillman

    Dianne Spillman

    • Associate Director, Global Regulatory Outreach
    • U.S. Food and Dru Administration, United States

  • David  Boudreau

    David Boudreau

    • Director of Medical Devices Bureau
    • Health Canada, Canada

    David Boudreau has a biochemistry and a chemical engineering degree with honours, both from the University of Ottawa. While at university, he did lab work at the National Research Council (NRC). He worked for three years at i-STAT, as a Process Engineer in the manufacturing of medical devices for blood tests. In March 2010, he joined the Office of the Commissioner of Official Languages (OCOL), as Special Advisor. In January 2014, he was promoted to the Assistant Director position, and was in charge of external audits and evaluations. In November 2014, he returned to the Patent Office as Director, where he was responsible for 145 employees. In January 2018, he joined Health Canada, as Executive Director of the Medical Devices Bureau.

  • Amber  McLeod, PhD

    Amber McLeod, PhD

    • Lead, Regulatory Affairs
    • Abbvie Corporation, Canada

  • Kelly  Robinson, MSc

    Kelly Robinson, MSc

    • Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
    • 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 is the Director of the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics in the Biologics and Genetic Therapies Directorate where she leads a team of multi-disciplinary scientists and clinicians who are responsible for reviewing biotherapeutic and radiopharmaceutical drug submissions. Kelly is also involved in initiatives such as international work sharing, HTA alignment and policy related to submissions relying on third party data.

  • Neerja  Goyal

    Neerja Goyal

    • Director, Regulatory Strategy and Policy
    • GlaxoSmithKline, Inc., Canada

  • Catherine  Hudon

    Catherine Hudon

    • Health Canada, Canada

  • Durhane  Wong-Rieger, PhD, MA

    Durhane Wong-Rieger, PhD, MA

    • President and Chief Executive Officer
    • Canadian Organization For Rare Disorders, Canada

    Durhane Wong-Rieger, PhD, is President & CEO, Canadian Organization for Rare Disorders; President, Institute for Optimizing Health Outcomes; Chair, Rare Diseases International; Treasurer, United Nations Non-government Organization for Rare Disorders; Chair, Patients Consortium of International Rare Disease Research Consortium; Patient Advisor, APEC Rare Disease Network; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Past Co-Chair, HTAi Patient / Citizen Involvement IG; Past Board, DIA International; Advisory Board, Canadian Institutes of Health Research Institute of Genetics. Durhane has a PhD in psychology from McGill and was professor at University of Windsor, Canada.

  • Robert W Platt, PhD

    Robert W Platt, PhD

    • Albert Boehringer Chair in Pharmacoepidemiology
    • McGill University, Canada

    Robert Platt is Professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University. He is Senior Investigator at the Research Institute of the McGill University Health Centre and the Lady Davis Institute of the Jewish General Hospital and holds the Albert Boehringer I Chair. Dr. Platt is the Executive Co-Lead and leader of the Methods team of the Canadian Network for Observational Drug Effect Studies. Dr. Platt is editor-in-chief of Statistics in Medicine and is on the editorial boards of the American Journal of Epidemiology and Pharmacoepidemiology and Drug Safety. He has published over 325 articles, one book and several book chapters on biostatistics and epidemiology.

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Additional Information

DIA Annual Canadian Meeting Resource Kit