Marilena Bassi has been with Health Canada since 2004 where she has held various policy, evaluation and performance management related positions. Currently she is the Senior Executive Director of the Therapeutic Products Directorate at Health 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.

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.

Rocelyn DelCarmen has 19 years experience working at various Canadian innovative pharmaceutical companies working primarily in the Regulatory Affairs-Quality Assurance areas, in addition to exposure to the reimbursement and sales areas. Rocelyn sits on the Regulatory Affairs committees at BIOTECanada and Innovative Medicines Canada.

Laura Durno worked as a Senior Evaluator at Health Canada for many years, reviewing pre and post-market quality submissions for biotherapeutic products. She has recently moved to Health Canada's Centre for Biologics Evaluation, where she manages the Viral Vaccines Division. Laura has a B.Sc. (Honours) in Life Science from Queen's University and an M.Sc. (Virology and Immunology) from the University of Ottawa.

Karen Feltmate is the President of Redstone Health Group Inc., a consulting firm providing regulatory strategy and guidance to the innovative Pharmaceutical industry. Karen has over 20 years of corporate executive experience primarily in the area of Canadian Federal registration and also manufacturing, packaging, quality and distribution. Karen holds a B.Sc. in Biology from McMaster University. She is a past Board member of both the Canadian Pharmaceutical Distribution Network (CPDN) and the University of Toronto Biotechnology Bridging Program. She is a member of the Drug Information Association, and was a founding member of the Canadian Association of Professionals in Regulatory Affairs (CAPRA).

Maggie Graham joined Health Canada in 2005. She has held various positions in the areas of site licensing, good manufacturing practices and risk management as well as in the Director General’s Office as Senior Policy Analyst and Senior Advisor to the Director General. Maggie Graham has a Bachelor of Science (Honours) in Life Science and Bachelor of Education from Queen’s 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.

Matthew Ryan is currently a Senior Policy Analyst in the Strategic Horizontal Policy Division within the Policy, Planning and International Affairs Directorate (PPIAD) at the Health Products and Food Branch (HPFB). He recently held the position of Senior Advisor in the both the Assistant Deputy Minister’s Office and the Director General's Office of the Therapeutic Products Directorate. In addition, during his over ten years with Health Canada, he has held project management and policy positions in the Bureau of Cardiology, Allergy and Neurological Sciences, the Bureau of Pharmaceutical Sciences and the International Affairs Directorate within the Strategic Policy Branch (SPB).

Jared Lantzy, PMP, is a Lead Associate in Booz Allen Hamilton's Civilian Services Group. His expertise is in the development, implementation, and maintenance of data standards for the life sciences. Mr. Lantzy is a former member of the FDA CDER electronic submission support team (eSUB team) and is a former employee of a leading electronic submission tool vendor.

Dr. Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, OBP, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA. He was Director of BioAnalytical Sciences at Genentech prior to joining FDA. Dr. Mire-Sluis was the Head of the Cytokine Group at NIBSC in the UK. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry.

E. Jane Mitchell, PhD, RAC, Associate Director, Regulatory Affairs, MAPI. Jane has broad experience, in biotech and consulting for 15+ years. Jane’s expertise includes early drug development, regulatory affairs, project management and electronic regulatory information management (RIM). Jane has a PhD from the University of Toronto in Biochemistry and Cell Biology. Jane’s postdoc was at the Laboratory of Molecular Biology (Cambridge, UK) and she worked at NRC’s Biotechnology Research Institute (Montreal) for several years in the receptor group. Jane is a member of DIA, RAPS, CAPRA and CSPS and an author for the RAPs publication Fundamentals in Canadian Regulatory Affairs. Jane has a particular interest in policy and regulatory sciences.

Jessica is a Patient Engagement leader who brings to Legacy Health Strategies a combined acumen of medicine and law, together with innovative thinking, to drive the culture change of increasing patient perspectives in medical product development to result in mutually beneficial outcomes for patients and industry. She is known as a credible and trusted thought-leader and collaborator, bringing novel solutions, digital strategies, and patient-centered approaches to biotech, med tech and pharmaceutical industries and across multi-stakeholder groups. She has deep knowledge of the pharmaceutical industry from leadership positions at GlaxoSmithKline and Takeda where she focused on building patient perspectives into the process of R&D.

Patricia is the Manager of the Risk Communications Section within the Marketed Health Products Directorate of Health Canada. Her section is responsible for providing central support for the development and dissemination of health product risk communications to healthcare professionals. Her section produces a monthly publication of safety issues for health professionals called Health Product InfoWatch (previously known as the Canadian Adverse Reaction Newsletter).

Laura Johnson received her Honour's Bachelor degree in Chemistry from the University of Ottawa. She joined Health Canada in 1995 as an officer responding to Access to Information requests, then held several positions related to submission management. Since 2003 Laura has been involved with the development and implementation of the Summary Basis of Decision (SBD) project. She currently manages the operational implementation of pre-market transparency initiatives and supervises the SBD technical writers in the Therapeutic Products Directorate, Health Canada.

Keith McIntosh is Executive Director, Scientific & Regulatory Affairs at Innovative Medicines Canada, and joined the organization in 2012. Previously, Keith spent 12 years in progressively senior policy and regulatory roles at another trade association. He has successfully advocated industry positions to federal, provincial and municipal departments and agencies covering a diversity of issues and topics. Keith has primary responsibility for the association’s interactions with Health Canada’s drug review bureaus, and developing the association’s positions on regulatory proposals and amendments. He also supports the work of the Regulatory Affairs and PMPRB committees, among others.

Dr. Brian O’Rourke is the President and Chief Executive Officer of CADTH. He joined CADTH in January of 2009 following a distinguished career as a Pharmacist and Health Service Executive with the Canadian military. With over 30 years of experience in health care, Brian actively positions CADTH as the leading Canadian source of evidence-informed advice on managing pharmaceuticals and health technologies. He has a Bachelor of Science in Pharmacy from Dalhousie University and a Doctor of Pharmacy from the University of Toronto.

Anne has practiced exclusively in the area of Regulatory Affairs in Canada since 1971. She has worked for three pharmaceutical companies: Wyeth, Roche and Searle. She started the regulatory consulting company, CanReg Inc, that was later sold to a US company. After working with the purchaser for 4 years, Anne set up her current regulatory consulting company, Therapeutic Products Inc. (TPIreg), which provides regulatory consulting in Canada and the US, including eCTD publishing. TPIreg also provides QA services in Canada and the US and holds and Establishment Licence with Health Canada as an importer. Anne operates out of Hamilton, Ontario.

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.

Linda has spent the last 30 years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK. She most recently was Chief of Staff, Pfizer Oncology Regulatory Strategy, a role she also had at Seagen. She has also been an Assistant Adjunct Professor in the Temple University RAQA graduate program since 1998. Linda attained Regulatory Affairs Certification for the US, Canada and Europe and was inducted into the 2011 Class of RAPS Fellows. Linda was honored with the RAPS 2020 Founder's Award and the DIA 2012, 2019, and 2022 Excellence in Volunteer Leadership Awards. She is immediate past chair of the DIA Regulatory Affairs Community and founded the DIA Regulatory Intelligence Working Group.

Agnes is an industry leader with over twenty years of experience in pharmacovigilance (PV) and medical information (MI) both in the pharmaceutical industry as well as in the consulting environment. She is a Vice President of Pharmacovigilance at Veristat, a CRO whose team includes experienced and dedicated PV professionals. Agnes in an expert PV auditor and a recognized pharmacovigilance educator engaged in teaching pharmacovigilance courses and presenting on various PV topics. Agnes holds a graduate degree in Pharmacology & Toxicology and, prior to joining the pharmaceutical industry, was involved in academic research.

Agnes V. Klein MD is currently the Senior Medical Advisor in the Director General's Office, in the Biologics and Genetic Therapies Directorate. Dr. Klein trained in Endocrinology at UofT and has interests in multiple aspects of drug development and medical bioethics. Dr. Klein is an active supporter for excellence in the development of medicines. In 2017 Dr. Klein received the Founders’ Award from the Regulatory Affairs Professional Society at the Annual Convergence in Washington, D.C.

Stephanie Hardy joined Health Canada in 2003 and is currently a manager in the Office of Policy and International Collaboration within the Biologics and Genetic Therapies Directorate. Her unit is responsible for the development of policies and guidance documents to support the regulatory review of biologic drug submissions, including biosimilars. Ms. Hardy has a Master of Public Health degree from the University of Waterloo, a BSc. in Biomedical Toxicology from the University of Guelph, and is a graduate of Seneca College’s Pharmaceutical Regulatory Affairs and Quality Operations Post-Graduate Program.

Dr. Morris is currently VP, Strategy Realization for the J&J CMO. Prior to joining J&J, Dr. Morris spent 18 years at Merck where she was VP, Global Project Management. Dr. Morris received her PhD in Organic Chemistry and completed postdoctoral research in biochemistry.

Marla Jo Brickman, PhD, is the Senior Director/Team Leader for the Clinical Trial Disclosure Group at Pfizer and serves as the global disclosure policy lead for all clinical trial registration and results disclosures, as well as, providing oversight of Pfizer’s implementation of the PhRMA/EFPIA principles. Marla received her PhD and completed her post-doctoral training in Immunology from Duke University, in Durham, NC.