Ariel E. Arias MD, PhD, FISPE Senior Advisor - Biologics and Genetic Therapies Directorate Health Canada. Dr. Arias has many years of experience in the drug regulatory assessment pre- and post-approval. He has worked on the development & implementation of various drug regulatory initiatives, and has represented Health Canada in various international technical committees (e.g., ICH, PAHO). Dr. Arias is also a professeur associé at the Faculty of Pharmacy of the Université de Montréal, an active member of the Signal Panel at the Uppsala Monitoring Centre, and a former North America Government/Regulatory Board representative of the International Society for Pharmacoepidemiology.

Dr. Irfan obtained her PhD in Neurophysiology in 2003 from the Institute of Neuroscience at Carleton University. She then completed a Post-doctoral fellowship from the Ottawa Health Research Institute in Neuropharmacology. She joined Health Canada in November, 2004 as a Scientific Drug Evaluator with the Marketed Pharmaceuticals and Medical Devices Bureau and is currently the Associate Director of this bureau. She has a particular interest in teratogenic effects and adverse events associated with the central nervous system. While at Health Canada, Dr. Irfan has led and managed several high profile drug safety files.

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.

Dr Kader Kourad is a Senior Clinical reviewer in the Clinical evaluation division Autoimmune & Endocrinology, BGTD. He joined BGTD in 1998 and since, he served within several positions including chief of a clinical evaluation division, Unit Head, Manager for Policy and Regulatory Affairs. Outside Health Canada, Kader has over 15 years of international experience (France, Canada) in different settings such as clinical practice (Medicine and Psychiatry in France) and clinical research (epidemiology, pharmacovigilance, clinical trials) including a position as Director of Clinical trials at the Children Hospital of Eastern Ontario.

Dr. Catherine Njue is the manager for the Office of Biostatistics in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Canada. In this position, she leads the biostatistics team that is primarily involved in evaluating the statistical methodology of clinical trials and other sources of evidence for biologics (e.g., vaccines, blood products) and related biotechnology products and radiopharmaceuticals. She also provides statistical expertise in the drafting, review and implementation of standards and guidelines developed by Health Canada, ICH, and WHO working groups.

Alisa Vespa is a senior drug evaluator for the Risk Management Division at Health Canada and has been involved in Health Canada's response to the risk of presence of nitrosamine impurities in pharmaceutical products. Alisa is co-leading the Nitrosamine International Technical Working Group (safety sub-team), a consortium of global regulators that share information on technical issues and approaches to (for example) establish Acceptable Intake limits for nitrosamine impurities. Alisa is also an active participant in the Health and Environmental Sciences Institute (HESI) sub-teams that are working to address data gaps and improve risk assessments for nitrosamines.

Dr. Jian Wang manages a team of scientific and clinical evaluators responsible for pre-market risk/benefit assessment. His division has regulatory responsibility for assessing non-clinical, pharmacology and clinical data for biological drugs for the treatment of haematological, oncological, and infectious diseases. At the moment, radiopharmaceuticals, gene therapies and biosimilars (regardless of their indications) are also regulated by the Division. Dr. Wang has broad regulatory experience in pre-market drug regulations for generics, biologics and biosimilars. He joined the Health Canada Pesticide Management Regulatory Agency in 1996.