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.

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).

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.

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.

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. 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).

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

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.

Rania Gaspo earned her Pharmacy Degree and her PhD at University of Montreal, Faculty of Pharmacy. She served as a Post-Doctoral fellow at Montreal Heart Institute before moving into industry in 1998 as a Senior Scientist. Rania joined Pfizer in 2003 where she held positions in medical information, medical affairs and clinical development in various therapeutic areas. She also served as a guest speaker for 24 years at University of Montreal. In her current role Rania leads a team of Experienced Medical Information Managers within Neuroscience and Pain category leadership in US and Canada and Globally. Rania authored/co-authored about 25 peer-reviewed publications and 50 scientific communications.

Nancy holds an Honours Bsc. in Biology from Brock University. Nancy was part of a team that worked on the renewal and implementation of the medical devices regulations in Canada in 1998. She is currently working with the International Programs Division. This division is responsible for managing international projects for both pharmaceuticals and medical devices. Nancy is currently working on medical device related projects, such as the medical device single audit program (MDSAP) and the Regulated Products Submission (RPS). Nancy was involved with the Global Harmonization Task Force for Medical Devices since 1999, participating as a member and later chair of Study Group 1 and the chair of the IVD subgroup.

Dr. Mugdha Chopra, Co-founder and Director of AWINSA Life Sciences, is a dental Surgeon by qualification with post-graduation in Clinical Research. She has an overall experience of 16 years, with extensive and deep-rooted knowledge of various Pharmacovigilance data bases, systems and processes. Her vast experience in the implementation of large Pharmacovigilance projects is another feather in her cap. She has been a speaker at various national and international conferences. She began her journey with a successful stint in Ranbaxy where she achieved excellence in management of Pharmacovigilance compliance. Later, she worked as Associate Vice President of Pharmacovigilance and Clinical Safety at APCER.

Dr. Leah Christl is Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen. She serves as head of the global regulatory affairs team within GRAAS with responsibility for development and execution of global regulatory strategy for Amgen’s biosimilars portfolio. Dr. Christl also leads the global biosimilars regulatory and R&D policy with responsibility to develop and advance Amgen’s policy positions. Prior to joining Amgen, Dr. Christl served as the Director of the Therapeutic Biologics and Biosimilars Staff at the US FDA. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina.

Dr. Basanti Ghosh is the Director of the Office of Pharmacoepidemiology and Data Analytics (OPEDA) in the Marketed Health Products Directorate in Health Products and Food Branch. OPEDA has the mandate of building and maintaining capacity to provide pharmacoepidemiological and statistical advice to MHPD review staff. The Office also facilitates MHPD's access to real world surveillance research through the management of Drug safety and Effectiveness Network Program within HPFB.

Andrea Gilpin is the General Manager of the Goodman Pediatric Formulations Centre. Dr. Gilpin began her career as a scientist and completed her Doctorate in Molecular Biology and Biochemistry from the University of Toronto. After obtaining her MBA, her career brought her through several different roles including working 12 years in small biotechnology companies in investor relations and communications. In 2011, she took a position working at Pfizer and later spent 5 as years working at Novartis, first as Head of Corporate Communications for Novartis Canada and second, in a marketing oncology position in the Lung and Melanoma franchise. She is the Vice Chair of the Board for BioTalent and has her ICD designation.

John Groskoph leads the PTx CMC function at Pfizer and has over 25 years of pharmaceutical industry experience. John has worked in a variety of regulatory, quality and production assignments and brings experience in Quality & Compliance Systems, clinical trial submissions through post-approval change management. John has a particular focus on bringing new technologies and new approaches through the CMC regulatory approval process. John holds a B.S. in Electrical Engineering from Lafayette College, Pennsylvania and an M.B.A. from Columbia University, New York, USA.

Mary Hill has over 20 years’ experience in both the regulatory and scientific area of health products. Ms. Hill’s career has also included working in the healthcare field. She currently leads the International Unit and activities in the Office of Policy and International Collaboration within Health Canada’s Biologics and Genetic Therapies Directorate. Ms. Hill was Health Canada’s lead for the Secretariat of the International Coalition of Regulatory Authorities. Ms. Hill has a BSc. in Physical Therapy from the University of Toronto and a Bachelor of Industrial Design from Carleton University.

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.

Sophie Lafrance has worked in federal regulations since 2005 when she joined Health Canada’s Health Products and Food Branch Inspectorate (now known as the Health Product Compliance Directorate, RORB). She is the national coordinator of the Good Pharmacovigilance Practices (GVP) inspection program since 2008. Her role is to support the delivery of Canada’s national GVP inspection program by providing support to inspectors for their inspections, assisting in resolving emerging issues arising from these inspections, liaising with the Marketed Health Products Directorate (MHPD), and contributing to the development of program regulations, policies, and guidelines.

Kelly has extensive experience in a variety of science-policy interface roles with Health Canada. She is currently the Associate Director for the Bureau of Metabolism, Oncology and Reproductive Sciences.

André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training in biochemistry and stem cell biology.

As the Senior Regulatory Affairs Director for Business & Technology Transformation, Donald works with the Regulatory Affairs and Drug Development Solutions (RADDS) team at IQVIA to add and update technology solutions to RADDS's business processes. His experience bridges the business and technology divide that spans Regulatory submissions, document management, and Regulatory Information Management, especially as they integrate with other departments and systems. Having worked in several organizations of different sizes, he provides perspectives from sponsors, vendors and now CROs. He is a strong proponent of standards and data governance.

Anu has an interdisciplinary Bachelor of Science (Honours) from the University of Toronto and a Master of Science (Neuroscience) from the University of Ottawa. She has worked as a Laboratory Manager and Regulatory Policy and Risk Management Advisor in the Health Products and Food Branch of Health Canada. Anu is currently a Senior Policy Analyst in the Emerging Science Policy Unit in the Science Policy Directorate of the Strategic Policy Branch at Health Canada and is an Innovation Designer at the Health Canada-Public Health Agency of Canada's Innovation Hub.

Evelyn Soo has been with Health Canada since 2009 where she has held various scientific and regulatory positions within the Department. She is currently Director of the Bureau of Gastroenterology, Infection and Viral Diseases in Health Canada's Therapeutic Products Directorate, and oversees regulatory operations for human prescription drugs, as well as program priorities in antimicrobial resistance.

Daniel O. Blackwood is a Director, Technology & Innovation, within PharmaTherapeutics Pharmaceutical Sciences at Pfizer. He received his BS in Mechanical Engineering from Cornell University in Ithaca NY, and his MS in Industrial Engineering from Columbia University in New York City. Currently, he is the technical program lead for Pfizer’s Portable, Continuous, Miniature, and Modular (PCM&M) development and manufacturing initiative for Oral Solid Dosages (OSD).

Before joining CADTH’s pCODR in 2014, Ms. Chambers was a Clinical Epidemiologist with Health Quality Ontario and the Ontario Health Technology Advisory Committee (OHTAC). Ms. Chambers holds a Masters degree from McMaster University, and a Bachelor of Science (Hons) degree from the University of Waterloo.

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.

Yolande Dufresne’s practice focuses on the areas of intellectual property and food and drug regulatory law. Yolande advises clients with regulated products in the food, pharmaceutical, biotechnology and medical device industries, in areas including product licensing, labelling and advertising, product recalls and corrective actions, privacy, access to information and anti-spam matters. Yolande also advises on intellectual property and related transactions, including the acquisition, enforcement and exploitation of patents, trademarks, copyrights and industrial designs.

Hoda Eid holds a Ph.D. from the Université de Montréal in Canada and a Post-Doctoral fellowship from the Brigham and Women’s Hospital and Harvard Medical School in Boston. Dr. Eid’s career in research lead her to the development of a model to investigate cardiac cell regeneration that was later sought by more than 30 laboratories in the world, resulting in articles still being published confirming the earlier observations and the prospect of repairing the damage caused by a heart attack. She joined the government to establish and to take on the lead in 2006 of the pre-market safety surveillance of drugs in development in 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 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.

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our reports into WordPerfect format for the FDA reviewer?" -- and he didn't say "no." Since then, he's been involved with content management, custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard both as a vendor/consultant and within biopharma companies.

Although most of her regulatory career in Health Canada has been spent in the pharmacovigilance world, she has recently migrated to the pre-market assessment of pharmaceuticals program in the Therapeutic Products Directorate. Lucye has significant work and management experience in the Health Products and Food Branch (HPFB), where she has held a number of management positions in different Directorates. She is currently Acting Director of the Bureau of Gastroenterology, Infection and Viral Diseases. Her academic specialization is pharmacology.

Dr. Harry L. Gewanter is the Immediate Past Chair of the Alliance for Safe Biologic Medicines (ASBM). A pediatric rheumatologist with over 3 decades of experience, he is an active member of the American College of Rheumatology, the American Academy of Pediatrics and the Arthritis Foundation, among others.A recipient of the ACR's Paulding Phelps Award he has also been an advocate on behalf of people with disabilities.

Patrick Massad is the Deputy Commissioner at the Pharmaceutical Advertising Advisory Board (PAAB). He's been with the PAAB for over 15 years. He also continues to work as a community pharmacist. He graduated from University of Toronto with a degree in Pharmacy.

Dr. Christopher McCabe is the Executive Director and CEO of the Institute of Health Economics (IHE).He is a Professor of Health Economics at the University of Alberta, and served as Professor of Health Economics a the Universities of Sheffield, Warwick and Leeds in the UK. From 2011-2017, Dr. McCabe held a the Capital Health Research Chair at the University of Alberta. From 2007-2011 he was Founding Director of the Academic Unit of Health Economics at the Leeds Institute of Health Science.

Chris has over 20 years’ experience in the health product industry and health product regulation. Chris is currently the Director of Program Implementation with the Government of Canada’s Cannabis Legalization and Regulation Secretariat. Chris is the former Director of Operations for the Office of Medical Cannabis, the group responsible for the licensing and oversight of the commercial medical cannabis program and registrations for personal cultivation in Canada. Chris’ career has also included operational leadership positions in the Health Products and Food Branch of Health Canada in the areas of medical devices, drug inspection and compliance, in addition to positions in private industry and at the provincial healthcare level.

Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa, second Undergraduate Degree in Computational Biology/Computer Science Graduate Degree in Genomics & Computer Science from McGill University.

Kathleen Barnard, Dip (ECCE) is the President of Save Your Skin Foundation. After completing her Diploma in Early Childhood Care and Education (ECCE) at Capilano University, Kathleen embarked on a career in business as a Corporate Accounting Manager, from which she moved on to be a Branch Manager for over a decade at Royal Bank of Canada. From there she moved into marketing and communications, as Stakeholder & Government Relations Manager at Insurance Corporation of British Columbia. She was the first woman to ever coach baseball in the Little League World Series. Kathy is also the recipient of the British Columbia Community Achievement Award for her leadership in addressing and raising awareness around skin cancer issues.

Patrick Caines, Ph.D., MBA is Senior Director, Quality & Compliance, Baxter Healthcare where he is responsible for the company’s global quality systems and compliance and post market surveillance. Patrick has over 20 years experience in quality systems and compliance for both medical devices and in-vitro diagnostics and served as Director, Corporate Post market surveillance, Boston Scientific, and GE Healthcare and Quality Director and Director of World-wide Customer Quality at Johnson and Johnson. Patrick served on the FDA Cases for Quality where he led the post production team and is currently leading his company’s post market surveillance and quality alignment.

Cheryl Cheung is an intellectual property lawyer and currently leads the litigation group of the Intellectual Property Team at Pharmascience. She is a member of the bar in Ontario and Quebec (as a Canadian legal advisor), and is a non-practising member of the New York bar. Before joining Pharmascience, Cheryl practiced at a law firm specializing in intellectual property, where she worked on various pharmaceutical patent and regulatory matters such as providing legal opinions and litigating cases commenced under the Patented Medicines (Notice of Compliance) Regulations.

Caroline Croteau has been with Pfizer Canada since 1996 assuming roles of increasing responsibility in medical information as well as medical quality operations and is currently head of the Drug Safety Unit for Pfizer Canada, where she oversees local pharmacovigilance activities. She is a licensed pharmacist with previous experience in both hospital and community settings. Caroline is a graduate from Laval University, School of Pharmacy and also holds a PhD in Medication and Population Health from University of Montreal, Faculty of Pharmacy.

Daniela Decina is Senior Director of Regulatory CMC at Mapi, leading a team focused on CMC strategy and dossier execution for all product phases for pharmaceuticals and biologics in the United States, Canada, and Europe. She has 28 years of experience in the pharmaceutical industry in Regulatory CMC, supporting small molecules and biologics, including biosimilars and vaccines. Prior to joining Mapi, Ms. Decina served two years in global public health within the World Health Organization’s Regulatory Systems Strengthening Team, supporting regulatory guidelines development and the Polio Eradication and Endgame Strategic Plan. She has a BS and MS degree in Microbiology from the University of Guelph.

Michael is the Director for Personalized Healthcare and Evidence Generation for Hoffmann-La Roche Limited. Michael is responsible for Roche’s strategy to advance the personalization of healthcare, as well as, managing the medical research portfolio in Canada. Michael received his undergraduate degree in Biology and Pharmacology and a Ph.D. in Medical Sciences with a specialization in Neuroscience, both from McMaster University.

Debra Haltrecht is a Manager in the Office of Legislative and Regulatory Modernization, part of the Health Products and Food Branch at Health Canada. She is responsible for the development of a broad range of legislation and regulations covering drugs, biologics and medical devices, including Vanessa’s Law, emergency measures, assisted human reproduction and regulatory review. Debra has a Master of Business Administration from the University of Ottawa. She has worked for the Federal Government for 20 years in various capacities from research to program implementation to regulatory development.

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.

Mai-Loan Leha, B. Pharm., M. Sc. Mai-Loan graduated from University of Montreal in 1992. She obtained her Master degree in Hospital Pharmacy in 1994, affiliated to the Jewish General Hospital and worked in at the Montreal Children's Hospital until 1998. She joined the industry with various responsibility at Medical Information and Clinical Supplies for Bristol-Myers Squibb, Pfizer Canada, and Novartis Canada. She also obtained her license in Ontario as pharmacist in the 1990's. She is also currently working as a community pharmacist in Quebec as a part-time pharmacist and acting as clinical pharmacist affiliated to the University of Montreal and Laval University for interns.

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.

Kirsten Mattison holds a Bachelors degree from the University of British Columbia and a PhD from the Oregon Health and Science University. She joined Health Canada as a research scientist in 2005, and has worked as a director on regulatory files including food safety, pathogen security and, for the past three years, controlled substances.

Mr. Nick Orphanos is a senior policy analyst with Health Canada, specializing in international affairs for drug regulation. Mr. Orphanos graduated from the University of Carleton in 2003 with a bachelor’s degree in Economics and joined Health Canada shortly after. Mr. Orphanos plays a key role in Health Canada’s membership at ICH as the ICH Coordinator while participating in the ICH Assembly and Management Committee activities. Mr. Orphanos currently also acts as the Secretariat for the International Pharmaceutical Regulators Forum (IPRF) and is also involved in Health Canada’s participation in the ACSS (Australia-Canada-Singapore-Switzerland) Consortium.

Refik is a staff scientist with Data & Analytic Services and the Cancer Program at ICES Central. He completed a MSc in statistics at the University of British Columbia and a BSc in mathematics at Brock University. Refik has been at ICES since 2004, spending most of his time on health services research in cancer, including screening, treatment and end-of-life care. His current work with Data & Analytic Services focuses on facilitating research led by external investigators with a wide range of topics, including assessing cardiovascular events associated with a specific drug therapy, exploring healthcare utilization and costs associated with smoking.

Brooke Casselberry is a leading Life Sciences consultant working with Life Sciences Organizations and Health Authorities to educate, develop, and deploy technologies as accelerators to regulatory initiatives. She has been awarded PharmaVoice top 100 of the most inspiring people, DIA's Excellence in Service award, and she has published a number of articles and public presentations on regulatory operations topics. Brooke is a programming chair for DIA Global Annual Meeting with the Data and Technology track and as well as the co-chair of the DIA Regulatory Affairs Community.

Andy Hua has been with Health Canada since 2003 and has worked in various regulatory, evaluation and operational positions. Andy recently joined the International Programs Division within the Therapeutic Products Directorate at Health Canada as a Senior Policy Advisor.

Alison Ingham obtained her B.Sc. (Chemistry and Biochemistry) at the University of the Witwatersrand in South Africa and her Ph.D. in Chemistry from the University of Victoria. She joined Health Canada and within the Therapeutic Products Directorate, she has worked in areas assessing Generic and New Drugs. Alison has been involved since 2004 with the Certification process at the European Directorate for the Quality of Medicines and Health Care, and was appointed as an external assessor by EDQM in 2006. She held the position of Manager of Product Assessment at the Natural Health Products Directorate for 5 years before returning to the Bureau of Pharmaceutical Sciences to her current position of Senior Advisor/Manager.

Barry D. Stein is an attorney and member of the Barreau du Quebec since 1981. An accomplished lawyer and president of the Colorectal Cancer Canada, he actively represents the interests of cancer patients and speaks regularly to medical professionals, industry, government and patient groups across Canada and internationally. Barry is a survivor of metastatic colorectal cancer diagnosed in 1995 and was obliged to seek health care outside of Canada to fight his disease. His judgement, obtained in the Superior Court of Quebec, serves as a leading precedent for the reimbursement of out of country health care.

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.