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.

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 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 started her career with AbbVie/Abbott in 1992 and has since assumed various roles of increasing responsibility in Regulatory Affairs, Pharmacovigilance, and Quality Assurance. She currently leads a team of Regulatory Affairs professionals primarily focused on biopharmaceutical clinical development and commercial product drug submissions in the areas of Immunology, Oncology, Virology, Neuroscience, Hormone Replacement Therapy, and Specialty Care. Judith also oversees Aesthetics and Medical Devices and is an active member of Innovative Medicines Canada’s Regulatory Affairs Operational Team and BIOTECanada’s Biologics Regulatory Affairs Group (BRAG).

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.

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.

Kristin Willemsen is the Vice President of Scientific and Regulatory Affairs at Food, Health & Consumer 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 Frappier is a Manager in the Office of Policy and International Collaboration at the Biologics and Radiopharmaceutical Drugs 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 COVID-19, rare diseases, genomics and antimicrobial resistance.

Dr. Rania Mouchantaf is A/Executive Director at the Marketed Health Products Directorate at Health Canada with over 17 years of experience in the area of pharmacovigilance. Before entering the public service she worked in the private sector, however her interest in pharmacovigilance and public health led her to join the federal government at Health Canada where she has assumed different roles in assessment, management and strategic policy development from both a pre and post market perspective in the area of safety, efficacy and quality Her education includes a Bachelor degree in Microbiology and Immunology and a doctorate degree in Pharmacology and Therapeutics from McGill University.

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

After obtaining his Chemistry degree from Acadia University in Nova Scotia, Gary Condran was employed for several years in the Regulatory Affairs Departments of two multi-national generic companies in the Toronto area. Gary joined Health Canada in 1995 and has since held several positions across the Department and is currently the Manager of the Quality Risk Management and Operations Division within BPS. He has been HC’s rep. on several ICH working groups including the QDG, Q1, Q3A&Q3B and was the Regulatory Chair for the Q11 Q&A document. Gary coordinates actions and responses to Quality risk and drug shortage issues, including those associated with nitrosamines and is Co-Chair of the Nitrosamines International Technical Working Group.

Megan Bettle joined Health Canada in 2005 as a drug safety reviewer, after a PhD and research in molecular biology and the genetics of rare diseases. Since then, she has taken on a number of roles in pre- and post-market drug review, cannabis policy, and tobacco and illicit drugs surveillance. She is currently the director of the Centre for Regulatory Excellence, Statistics and Trials in the Biologics and Genetic Therapies Directorate, a horizontal science team including regulatory intelligence, drug submissions management, regulation of clinical trials for biologics, pediatric strategies, and ongoing work on Health Canada’s Regulatory Review of Drugs and Devices.

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 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 Associate Director General of the Policy, Planning and International Affairs Directorate, and the Executive Director for Regulatory Innovation in Health Canada’s Health Products and Food Branch. She helps lead her Branch towards greater agility in Canada’s food and drug regulations to support enhanced safety and innovation.

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.

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 was a member of the ICH E8 working group on General Considerations for Clinical Studies and the ICH E6 working group on Good Clinical Practice.

Dr. Trevor Richter is the Director of Pharmaceutical Reviews at CADTH. He has worked at CADTH for the last eight years with a focus on managing clinical reviews of pharmaceuticals. Prior to joining CADTH, Dr. Richter was involved in various forms of clinical research for more than a decade, both as an academic researcher and in the pharmaceutical industry. He has an MSc in physiology and a PhD in neuroscience from Cambridge University.

Andrew Casey became president and CEO of BIOTECanada in August, 2012. In his role as President & CEO of BIOTECanada Andrew is responsible for the strategic operations of the Association representing Canada’s biotechnology sector. As the head of BIOTECanada, he is the lead spokesperson for Canada's biotechnology industry communicating on the industry's behalf with government, regulators, international bodies, media and the Canadian public.

Mandy Collier is the Director of the Office of Planning, Performance and Review Services in the Pharmaceutical Drugs Directorate (PDD) of Health Canada. She has worked in the Health Products and Food Branch (HPFB) for over 15 years in a variety of policy, advisory and management positions in the PDD, Biologic and Radiopharmaceutical Drugs Directorate, and the HPFB Assistant Deputy Minister’s Office. She has a degree in pharmacology from McMaster University.

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.

Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada. He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently leading the Data Analytics team within the Data Analysis and Methods Task Force.

Celia Lourenco, PhD has been the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada since November 2018. 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 has contributed to international initiatives such as ICH and IPRP, she co-chairs the ICMRA COVID-19 working group and participates on DIA's Council of Regulators.

Khyati Roberts leads regulatory policy advocacy efforts for U.S. and Canada and co-leads the day-to-day operations of the global regulatory policy and intelligence team at AbbVie. She has over 30 years of regulatory experience including nearly 14 years at the U.S. FDA/Center for Drug Evaluation and Research (CDER) developing and implementing policies for a wide range of Center level initiatives, coordinating all legislative activities for CDER as well as being the primary contact for to all other governmental agency inquiries for issues relating to CDER. Khyati also worked as a regulatory consultant for product strategies prior to joining AbbVie. Khyati attended Rutgers, College of Pharmacy where she obtained her pharmacy degree.

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 is the Associate Director for Global Regulatory Outreach in the Oncology Center of Excellence. She holds a Bachelor of Science in Biology from Northeastern University, Boston, MA. Her government service spans over 30 years, with the majority in FDA oncology Divisions and Offices. From late 2005-early 2019, she was the Lead Project Manager for the Oncology Program in the Office of Hematology and Oncology Products. Currently, Dianne facilitates OCE interactions with foreign regulatory counterparts and was instrumental in the first international collaborative review between Australia, Canada, and the US under Project Orbis.

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.

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.

Stephen is a Senior Quality (CMC) Reviewer in the Bureau of Pharmaceutical Sciences, TPD, Health Canada. Stephen earned a Ph.D. in synthetic organic chemistry (Waterloo, ON) and completed post-doctoral research at Stanford University (Palo Alto, CA). He has over 25 years of industrial experience in the areas of medicinal chemistry, API process R&D and manufacturing, regulatory affairs, quality, and senior management, and holds more than 40 publications and patents.

Amber McLeod has held the role of Lead, Regulatory Affairs at AbbVie Canada since May 1, 2020. She leads a team of Regulatory Affairs professionals focused primarily on the filing and approval with Health Canada of biopharmaceutical drug submissions for clinical development and commercial products in the areas of Immunology, Oncology, Virology, Neuroscience, Hormone Replacement Therapy, and Specialty Care. Amber joined Abbott in January 1999. Over her 24-year career with Abbott/AbbVie, she held various roles of increasing responsibility where she led and managed countless regulatory filings, approvals and product launches in different therapeutic areas. Amber holds a Doctorate in Pharmacology and Therapeutics from McGill University.

Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market regulation of biologics and pharmaceuticals. Kelly has been involved in initiatives such as international work sharing under Access and Project Orbis, HTA alignment and policy related to submissions relying on third party data. Kelly rejoined the Marketed Health Products Directorate as the Director General in 2020, where she leads a diverse team responsible for post-market activities including RWE, Advertising, Risk Management and Health Product Vigilance.

Dr. Andy J. Smith is the President and Chief Executive Officer of Sunnybrook Health Sciences Centre in Toronto, Ontario. In addition, he is a Professor of Surgery at the University of Toronto. He completed medical school, including a Masters of Science, and General Surgery residency at the University of Toronto. He also completed a Surgical Oncology Fellowship at Memorial Sloan-Kettering Cancer Center in New York. Upon returning to Canada, he established himself as a leader in the management of colorectal cancer. Most recently, Dr. Smith has served Sunnybrook as its Executive Vice President, Chief Medical Executive.

Neerja is currently the Director of Regulatory Strategy and Policy at GSK. She has held various positions over the years and has been in a leadership position in Regulatory for over 20 years. She is also an active member of the Regulatory Affairs Operational Team at Innovative Medicines Canada and been involved in a number of initiatives aimed at improving the predictability and efficiency of the regulatory process in Canada.

Catherine is the Director of Compliance Policy and Regulatory Affairs in Health Canada’s Regulatory Operations and Enforcement Branch. In this role, Catherine leads a broad range of compliance and enforcement policy initiatives. Most recently, this has included the interim order on exceptional importation in response to the COVID-19 pandemic. Catherine has over 15 years of policy experience in the Government of Canada, having worked in departments such as Indigenous and Northern Affairs, Economic and Social Development, and the Treasury Board Secretariat.

Dr. Nicole Mittmann is CADTH’s Chief Scientist and Vice-President of Evidence Standards. At CADTH, Dr. Mittmann leads a diverse portfolio that encompasses Health Economics, Research Information Services, Scientific Affairs, including Scientific Advice and Patient Engagement, and Implementation Support and Knowledge Mobilization. She is responsible for building upon the agency’s strong methods frameworks and global networks with academia and representing CADTH both nationally and internationally. Current initiatives include harmonization of the deliberation processes and frameworks and determining the role of real-world evidence at CADTH. In her academic capacity, Dr. Mittmann holds a faculty position at the University of Toronto

Andrei Spinei is the Team Lead for manufacturing in the Inspection Office at EMA that deals with GMP inspections, quality defects and product recalls, sampling and testing and international collaborations on GMP and inspections. In his role Andrei works very closely with the GMDP Inspectors Working Group. He holds an MSc. in Pharmacy and before joining the European Medicines Agency he has worked for several years in regulatory affairs in the pharmaceutical industry.

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.

Tony Bristow is Principal Scientist for Measurement Science at AstraZeneca (Macclesfield, UK), leading the development and delivery of analytical science strategy (2018-to date). Prior to this Tony’s focus was the application and development of mass spectrometry (2005 - 2018). Tony is the Chair of the Industry Advisory Board of the Community for Analytical Measurement Science, a former member of the Royal Society of Chemistry Analytical Division Council (2013-2019) and former Chair of the British Mass Spectrometry Society (2012-2014). Tony was awarded a degree in Applied Chemistry in 1992 and his PhD (mass spectrometry) in 1996. Tony previously worked for Kodak and LGC focussed on a variety of analytical science based projects. Tony is an a

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.