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DIA Annual Canadian Meeting


Speakers

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Loretta  Del Bosco

    Loretta Del Bosco

    • Director, Regulatory Affairs Quality Assurance Operations
    • AbbVie Corporation, Canada

    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  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.

  • 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 16 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

    Lisa Chartrand

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

    Lisa Chartrand began her 20 year 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 and Quality Management in 2014. Lisa is an active member of both Innovative Medicines Canada's Regulatory Affairs Committee and 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 the Toronto Institute of Pharmaceutical Technology in Quality Assurance.

  • Robin  Churchill, PhD, MSc

    Robin Churchill, PhD, MSc

    • Director
    • Health Canada, Canada

    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  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

    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

  • Kyle  Burns

    Kyle Burns

    • Senior Director
    • Treasury Board of Canada Secretariat, Shared Services Canada, Canada

  • Deirdre  Cozier

    Deirdre Cozier

    • Director, Global Regulatory Affairs
    • Pharmascience, Canada

    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

    Oxana Iliach, PhD

    • Senior Director, Regulatory Affairs
    • IQVIA, Canada

    Oxana Iliach, PhD is a Sr. Director Regulatory Affairs at Pediatric and Rare Diseases Center of Excellence, IQVIA. She works with the team of dedicated professionals to develop and implement practical and creative strategies for development drug for rare diseases, which often involves pediatric indications. She provided regulatory support for development of new orphan drugs as well as biosimilars of orphan drugs. She is also professor at Seneca College of Applied Arts and Technology and a member of CORD Board of Directors, CAPRA and RAPS.

  • Dana  Bruce

    Dana Bruce

    • Manager, Strategic Policy Directorate Controlled Substances and Cannabis Branch
    • Health Canada / Government of Canada, Canada

  • Mohammed Toseef Ansari, MD, MSc

    Mohammed Toseef Ansari, MD, MSc

    • Senior Scientific Evaluator
    • Health Canada/Marketed Health Products Directorate, Canada

    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, MBA, MSc

    Marcin Boruk, MBA, MSc

    • Manager
    • Health Canada, Canada

    Marcin Boruk is a manager in the Information Sciences and Openness Division, Health Canada working on the projects related to clinical data transparency.

  • 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.

  • 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. Kelly has an MSc from the University of Aberdeen in Scotland and a BSc from Queen’s University in Kingston.

  • Olaf  Schoepke, PhD

    Olaf Schoepke, PhD

    • VP Regulatory Solutions, Samarind
    • Instem, United Kingdom

    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, MA

    Scott Smith, MA

    • Sr. Director, Intellecual Property and Innovation Policy
    • Canadian Chamber of Commerce, Canada

    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, MA

    Elizabeth Toller, MA

    • Executive Director, Regulatory Innovation
    • Health Canada, Canada

    Elizabeth Toller is the Executive Director of Regulatory Innovation for the Health Products and Food Branch of Health Canada. She is responsible for driving the Branch's work to modernize its regulations so that they are more able to adapt to innovation. Her work focuses specifically on implementating commitments arising from the Government of Canada's Regulatory Review of the Health and Biosciences Sector.

  • Sandra  Usik

    Sandra Usik

    • Associate VP, Reg. Affairs, Quality & Compliance
    • Eli Lilly Canada Inc, Canada

    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, MSc

    Louise Blythe, MSc

    • Head of Regulatory & Scientific Affairs
    • EMD Serono Canada, Canada

    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.

  • Jan  Brozek, MD, PhD

    Jan Brozek, MD, PhD

    • Associate Professor, Health Research Methods, Evidence, and Impact
    • McMaster University, Canada

    - 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, MS

    Jason DiMuzio, MS

    • Label Review Coordinator, Non-Prescription Drugs Evaluation Division
    • Health Canada, Canada

    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

    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.

  • Diana  Johnson

    Diana Johnson

    • VP Regulatory Affairs
    • Medtech Canada, Canada

    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, MPA

    Talia Lacroix, MPA

    • Senior Policy Analyst
    • Health Canada, Canada

    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  Lamoureux, MSc

    Marc Lamoureux, MSc

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

    Marc has worked for Health Canada’s Medical Devices Bureau 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 newly created Digital Health Division at the Medical Devices Bureau of Health Canada.

  • David K. Lee, JD

    David K. Lee, JD

    • Chief Regulatory Officer
    • Health Canada, 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.

  • 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.

  • Michelle  Leroux

    Michelle Leroux

    • Senior Clinical Project Leader
    • NoNO Inc., Canada

    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.

  • Meggan  Davis

    Meggan Davis

    • Director, Policy, Regulatory and International Affairs Division
    • Health Products and Food Branch, Health Canada, Canada

  • Meghana  Chalasani, MHA

    Meghana Chalasani, MHA

    • Senior Research Analyst, Office of the Center Director, CDER
    • FDA, United States

    Meghana Chalasani currently serves as a senior research analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). She works closely on CDER’s various PFDD initiatives and provides strategic, regulatory, program, and policy assistance to facilitate the incorporation of patient input into decision-making. Prior to joining the FDA in July 2015, Meghana worked on Capitol Hill and for FasterCures. She also has a strong biomedical research and clinical experience background in genomic medicine and infectious diseases. Meghana holds a master’s degree in Health Policy and Management from Columbia University and a bachelor’s in Medicine, Health and Society from Vanderbilt University.

  • Jennifer  Chan, MSc

    Jennifer Chan, MSc

    • Vice President, Policy and External Affairs
    • Merck Canada Inc., Canada

  • Kim  Dayman-Rutkus, LLM

    Kim Dayman-Rutkus, LLM

    • Senior Regulatory Advisor
    • Health Canada, Canada

    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  Elmi

    Ugbaad Elmi

    • Regulatory Affairs Leader
    • GE Healthcare, Canada

    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, MBA

    Kimberley Hanson, MBA

    • Executive Director, Federal Affairs
    • Diabetes Canada, Canada

    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, PhD, MS

    Jeremy Jokinen, PhD, MS

    • Senior Director, Decision Sciences
    • AbbVie, Inc., United States

    Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, statisticians, and data managers developing novel analytical approaches and methodologies to improve patient safety. Jeremy is also active within numerous TransCelerate PV initiatives and is a deputy topic lead for ICH E19. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, and medical device research. He holds MS and PhD degrees in quantitative psychology from Ohio University.

  • Jovana  Kapor, MD, MSc

    Jovana Kapor, MD, MSc

    • Senior Medical Director, Medical Strategy Lead, Endocrinology
    • Endocrinology Center of Excellence, IQVIA, Canada

    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  Moers, MSc

    Sabrina Moers, MSc

    • Associate Director, Regulatory Afffairs
    • Merck Canada Inc., Canada

    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.

  • Trevor  Richter

    Trevor Richter

    • Director of Pharmaceutical Reviews
    • CADTH, Canada

    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.

  • David  Sealey, PhD

    David Sealey, PhD

    • Associate Director, Regulatory Affairs
    • Janssen Inc., Canada

    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.

  • Rong  Sun, PhD

    Rong Sun, PhD

    • Associate Director with the Centre for Evaluation of Radiopharmaceuticals and Bi
    • Health Canada, Canada

    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, PhD

    Tanya Ramsamy, PhD

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

    Dr. Tanya Ramsamy obtained her PhD from the University of Ottawa. Following her training, Dr. Ramsamy joined Health Canada and has 15 years of experience in the area of clinical trials and premarket drug review. Dr. Ramsamy started as a reviewer assessing clinical trials before taking on managerial roles within the Therapeutic Products Directorate (TPD) where she managed both the Clinical Trials Group within the Office of Clinical Trials (OCT) and the Division of Anti-Infective Drugs within the Bureau of Gastroenterology, Infection and Viral Diseases. Dr. Ramsamy is currently the Associate Director within OCT and is actively involved in the regulations of cannabis clinical trials and modernizing the regulations for clinical trials.

  • Patrick  Fandja

    Patrick Fandja

    • Manager, Medical Devices Section
    • Health Canada, Canada

    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 managing the team responsible for the post-market surveillance of medical devices 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

  • Jaigi P Mathai

    Jaigi P Mathai

    • Assessment Officer
    • Health Canada, Canada

  • Dawn P. Richards, PhD

    Dawn P. Richards, PhD

    • Vice President
    • Canadian Arthritis Patient Alliance, Canada

    Dawn Richards, PhD, lives with rheumatoid arthritis and is a volunteer Vice President of the Canadian Arthritis Patient Alliance. She advocates for arthritis awareness, access to treatments, patient participation in decision-making and as research collaborators, and the importance of research. Professionally, her firm, Five02 Labs Inc., intertwines her formal training as an analytical chemist with her passion for the patient perspective to inform research and healthcare. Clients include the Network of Networks, Clinical Trials Ontario (where she is the Director of Patient and Public Engagement), the SPOR Chronic Pain Network, and the CIHR Institute of Musculoskeletal Health and Arthritis.

  • Kate  Gurd, PhD

    Kate Gurd, PhD

    • Senior Assessment Officer
    • Health Canada, Canada

    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.

  • Katherine M. Soltys, MD

    Katherine M. Soltys, MD

    • Director
    • Health Canada, Canada

    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.

  • Representative Invited

    Representative Invited

    • Health Canada, Canada

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