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.

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. 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.

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.

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.

Loretta has spent several decades in the Canadian pharmaceutical industry and is the current Director, Regulatory Affairs, Quality Assurance and Operations, AbbVie Canada, the Vice-Chair of Canada’s Innovative Medicines Canada Regulatory Affairs Committee and member of BIOTECanada’s Subsequent Entry Biologics Committee and Biologics Regulatory Affairs Group. A member of the McGill University Faculty of Science Advisory Board and Microbiology and Immunology McGill graduate.

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 sciences 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.

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.

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.

Dr. Robin Churchill is the director of the Bureau of Policy, Risk Management and Stakeholder Engagement in the Natural and Non-prescription Health Products Directorate of Health Canada. She has held several positions in the health and agriculture portfolios focusing on chemical safety across a number of product lines. Robin holds a PhD in environmental Biology (antibody engineering) from the University of Guelph, an MSc in biochemistry from Memorial University of Newfoundland and a BSc (Hon) from the University of Calgary.

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

Deirdre has 25 years’ experience in the area of international regulatory affairs. She has extensive experience in the preparation and management of drug submissions including Clinical Trial Applications, New Drug Submission and all related variations. She is also a recognized expert in Canadian health product advertising and regulatory operations. She has comprehensive knowledge of strategy development and execution and training and education and has presented at several major conferences over the years.

Oxana Iliach, PhD is a Sr. Director, Regulatory Strategy and Policy at Certara/Synchrogenix. She has more than 15 years of experience in the healthcare industry including the last 10+ years in regulatory affairs. Her specialty is developing and executing regulatory strategies for drugs for rare diseases, pediatrics, advanced therapy products and biosimilars, with a focus on Chemistry, Manufacturing and Control (CMC). Oxana has experience with the FDA, EMA, Health Canada, and other smaller agencies. She is also a part-time lecturer at Northeastern University, Toronto campus and professor at Seneca College of Applied Arts and Technology. Oxana is a member of CAPRA, RAPS, CORD and IRDiRC.

Mohammed Ansari is a Senior Scientific Evaluator at the Marketed Pharmaceutical and Medical Devices Bureau, Health Canada, and holds faculty appointments at the University of Ottawa and the University of Nottingham-Ningbo. With experience in Evidence-based Medicine, Clinical Epidemiology and Meta-research, he is also a member of the Cochrane and the GRADE working group. Mohammed's research interests include evaluation of the validity of evidence and evidence-based decision-making.

Marcin Boruk has been with Health Canada since 2005 and has worked in the areas review, legislation and business transformation. Currently he is a manager in the Information Sciences and Openness Division, Health Canada supporting the branch in projects related to data governance, stewardships and standards.

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.

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. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document and submission management.

Scott Smith is the Senior Director, IP and Innovation Policy at the Canadian Chamber of Commerce and the Director of the Canadian Intellectual Property Council. Scott leads the Canadian Chamber’s advocacy activities in the areas of intellectual property protection, innovation and industry productivity, the digital economy and research and development issues. Scott is a delegate on the International Chamber of Commerce Commission on the Digital Economy and the B20 Task Force on the Digital Economy. Scott has written and spoken extensively on the subjects of data governance, emerging technology and data security. Prior to joining the Chamber, Scott held senior management positions in the energy, automotive and environment sectors.

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.

Sandra is currently the Associate VP Regulatory Affairs, Quality and Safety for Eli Lilly Canada Inc., an importer and distributor of pharmaceuticals and Medical Device Products as well as clinical trial sponsor , where she has oversight and responsibility for all regulatory, quality and pharmacovigilance activities. Sandra has over 24 plus years experience in the industry and holds a Bachelor of Science degree from the University of Guelph

Louise Blythe is the Head of Regulatory and Scientific Affairs at EMD Serono Canada, a business of Merck KGaA Darmstadt, Germany. Louise has over 20 years of experience in the pharmaceutical industry and has been involved in pharmaceutical and medical device development, registration and post-marketing activities. Prior to joining EMD Serono, Louise held various positions in Regulatory Affairs at several large multinational pharmaceutical companies. Louise holds an Honours Bachelor of Life Sciences degree from Queen’s University and a Master of Science, Pharmacology degree from the University of Toronto.

- Contributed to new methods for evidence synthesis (systematic reviews) and making practice recommendations for clinical and public health guidelines; specifically the presentation and interpretation of the evidence about diagnostic tests and local adaptation of guidelines. - Actively involved in the GRADE Working Group and Cochrane - Developed numerous guidelines with professional societies and organizations. - Recognized by Clarivate Analytics (formerly: Thomson Reuters) as one of the Most Highly Cited Researchers - Recently focused on the development of methods for automation of evidence synthesis for systematic reviews and health care guidelines.

Jason DiMuzio serves as the Label Review Coordinator in the Natural and Non-prescription Health Products Directorate. Jason brings expertise in plain language labelling in support of label reviews. Previously, he worked as an NHP Coordinator and as a Scientific Evaluator. Jason holds a Master of Science in Health: Science, Technology and Policy (Carleton University) and an Honours Bachelor’s Degree with Specialization in Chemistry (University of Ottawa).

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.

Educated in the UK, I am a Chartered Biologist and currently VP of Regulatory Affairs at Medtech Canada, Canada’s national association of medical technology companies. Represent Medtech Canada members in the areas of domestic and international regulatory affairs, promoting global harmonization both directly, and with other trade associations. Prior to joining Medtech Canada in April 2018, I was an active industry regulatory affairs professional with 30 years’ experience with prescription and over-the-counter drug products, including over 15 years experience with Medical Devices, Natural Health Products, and Cosmetics, and 5 years leading a Clinical Research team.

Talia Lacroix is a Senior Policy Analyst in Health Canada’s Health Products and Food Branch, the area that regulates the safety, quality, and efficacy of drugs and devices in Canada. Talia has spent the last 15 years contributing to regulatory frameworks, guidance, and policy; including capacity building and reform initiatives. She has served as an International Liaison and been an Advisor within her Branch. Talia recently began working in Health Canada’s new Office of Paediatrics and Patient Involvement where she is exploring opportunities to enhance and integrate patient expertise throughout product lifecycles. Talia is a Member of the CIOMS Working Group examining Patient Involvement in the Development and Safe Use of Medicines.

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.

David K. Lee is the Chief Regulatory Officer for the Health Products and Food Branch, Health Canada. He was previously the Director of the Office of Legislative and Regulatory Modernization. In this capacity, he led modernization initiatives for the Food and Drugs Act and Regulations. Prior to that, he was the Director of the Office of Patented Medicines and Liaison. David received his law degree at Queen’s University and articled at the Federal Court of Canada. He has lectured extensively on intellectual property law and food and drug law both nationally and internationally.

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.

Michelle Leroux is a clinical researcher with over 13 years experience in both academic and industry phase I through IV clinical trials. She has worked across a range of therapeutic areas, including stroke, acute coronary syndromes and oncology. Having held roles at clinical sites as a Research Coordinator and at sponsors as a Clinical Research Associate and Project Manager, she has worked on trials throughout their life cycle and has been responsible for various operational tasks, including conducting subject consent discussions and study visits, site monitoring, and overall trial management. Michelle joined NoNO Inc. in 2016 and is exclusively working on the development of pre-hospital and in-hospital treatments for acute stoke.

Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused Drug Development initiatives to facilitate the incorporation of patient and caregiver input into decision-making. Prior to joining the FDA, Meghana worked on Capitol Hill and for FasterCures. She also has a strong biomedical research background in genomic medicine and infectious diseases. Meghana holds a master’s in Health Policy and Management from Columbia University and a bachelor’s in Medicine, Health and Society from Vanderbilt University.

Kim Dayman-Rutkus worked as a director of compliance policy for over 10 years at Health Canada, leading initiatives related to policy and regulatory direction in the areas of health products quality, facilities, supply chain and compliance monitoring. She is presently the ROEB senior regulatory advisor for matters relating to the Food and Drugs Act with a particular focus on oversight of emerging technologies.

Ugbaad is a Regulatory Affairs Leader at GE Healthcare and is currently a co-chair of the eHealth Initiatives subcommittee at Medtech Canada, where she has led/supported engagements with Health Canada regarding Software as a Medical Device (SaMD), cybersecurity, and artificial intelligence. Ugbaad earned her Honours Bachelors of Science in Neuroscience from the University of Toronto and holds a certificate from Humber College in Regulatory Affairs.

Kimberley Hanson is Executive Director of Federal Affairs at Diabetes Canada, responsible for advocacy with the federal government and on national issues. She also leads the Diabetes 360° initiative to implement a nation-wide strategy to address the diabetes epidemic. Having lived with diabetes for nearly 25 years, Kim is passionate about helping others live well with the disease while also working towards a cure. Over the past 15 years, Kim and her family have raised more than $1 million for research into a cure for diabetes and for supports for adults living with type 1 diabetes.

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

Dr. Kapor is an endocrinologist with 10 years’ experience as a practicing clinician and over 18 years of Pharmaceutical industry experience in roles ranging from Clinical Project Manager within R&D to executive leadership for Canadian Medical Affairs, overseeing multiple therapeutic areas. Her graduate training includes a MSc degree in Medical Sciences from the University of Toronto. She joined IQVIA in 2017 as a Senior Medical Director and Medical Strategy Lead for the Endocrinology Center of Excellence for Americas. She works with cross-functional professionals to develop efficient, medically and scientifically sound clinical research strategies for the development of products for diabetes and other endocrinopathies.

Sabrina is currently an Associate Director in Regulatory Affairs at Merck Canada and has been with the company for over 15 years. Prior to joining the Pharmaceutical Industry, she was at Health Canada's Therapeutic Products Directorate for 2 years. Sabrina holds a Bachelor's degree in Medical Biology and a Masters in Pharmaceutical Sciences.

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.

Dr. David Sealey is Associate Director of Regulatory Affairs at the Janssen Pharmaceutical Companies of Johnson & Johnson. His current focus is the use of Real World Evidence for regulatory decision making. David has guided drug development programs at various stages from pre-clinical to marketing authorization to post-marketing. David trained as a cancer biologist at the Campbell Family Institute for Breast Cancer Research/Ontario Cancer Institute. He holds a Ph.D. (Medical Biophysics) and Hon.B.Sc. (Pharmacology) from the University of Toronto.

Dr. Rong Sun is the Associate Director with the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Health Canada. In her previous capacity as Senior Policy Advisor with the Office of Policy and International Affairs, Health Canada, Rong led the international working group studying novel approaches to drug licensing, a part of the Strategic Priority for Innovation of the International Coalition of Medicines Regulatory Authorities. Rong held various positions in healthcare organizations, academia and the Government of Canada. Rong has a PhD from the University of Ottawa specializing in medical education, as organizational innovation and uptake.

Tanya Ramsamy obtained her PhD from the University of Ottawa and joined Health Canada in 2005. Tanya has held numerous reviewer and management positions in the (former) Natural Health Products Directorate and the Therapeutic Products Directorate. More recently, Tanya was the Associate Director in the Office of Clinical Trials where she was actively involved in clinical trial modernization and in Health Canada’s response to COVID-19 and an Associate Director in the Medical Devices Directorate (MDD) responsible for managing the applications for COVID test devices. She is currently the Executive Director of the Bureau of Investigational Testing Authorization, Special Access Program and Post-Market Surveillance in the MDD.

Patrick Fandja has been with Health Canada since 2003 where he held various positions in regulatory area and scientific evaluation of health products. Currently, he is the Director of Bureau of Biologics, Radiophamaceuticals and Self-care products within the Marketed Health Product Directorate at Health Canada. Patrick has a Master in Pharmaceutical Sciences from Université de Montréal, and MBA from Université de Québec à Montréal and Paris Dauphine.

Dawn Richards, PhD, is the founder of Five02 Labs Inc., and Director of Patient and Public Engagement at Clinical Trials Ontario. With a PhD (Analytical Chemistry) from the University of Alberta, and experience in a variety of roles during the past 20 years, it is her diagnosis with rheumatoid arthritis in 2006 that led her on a journey to combine her passion for science with making the most of her diagnosis. In her role at CTO, Dawn is charged with executing on CTO’s strategic pillar of patient and public engagement.

Dr. Gurd is a senior assessment officer at the Therapeutic Products Directorate of Health Canada. She has 12 years of experience working for Health Canada, primarily as an evaluator of pre-market oncology drug submissions . Her education includes a Bachelor’s degree in biochemistry from Mount Allison University and a doctorate in biochemistry from McGill University.

Dr. Soltys received her MD degree and completed her post-graduate training at the University of Saskatchewan. In addition to her regulatory work, Dr. Soltys maintains part time clinical practice at The Ottawa Hospital Cancer Centre where she is involved in the care of patients with lung cancer.