Dr Arias has many years of experience in the assessment of pharmaceuticals and biologics both pre- and post-approval in Health Canada, where he became the Chief of the Clinical and Risk Evaluation Division in the Centre for Blood and Tissues Evaluation. He has provided expert advice during the development and implementation of various drug safety regulatory initiatives in Canada. Dr Arias is also an adjunct professor (professeur associé) at the Faculty of Pharmacy of the Université de Montréal, an active member of the Signal Panel of the WHO Centre for International Drug Monitoring / the Uppsala Monitoring Centre, and the current North America Government/Regulatory Board representative in the International Society for Pharmacoepidemiology (ISPE).
Dr Berthiaume received his M.D. from the University on Montreal in 1990, and completed his residency in family medicine in 1992. He practiced medicine in a rural setting from 1992 to 2002. He has also served administrative roles in the institutions where he practiced, and has actively participated in various regional and provincial committees related to health service delivery.
He joined the Marketed Health Products Directorate of Health Canada in 2003 as a clinical section manager, and was appointed in 2005 as Director of the Marketed Pharmaceuticals and Medical Devices Bureau, the organization involved in post-market safety risk assessment and management for pharmaceuticals and medical devices in Canada. He continues to practice clinical medicine on a part time basis. He completed in 2007 a Certificate in Pharmacoepidemiology and Pharmacovigilance at the London School of Hygiene and Tropical Medicine.
Stella Blackburn qualified in Medicine from Cambridge University and Guy’s Hospital Medical School. Following a short spell in hospital medicine at Guy’s, Guildford and the Royal Marsden, she joined the pharmaceutical industry. Stella worked in the industry for 11 years, initially in pharmacovigilance but latterly in pharmacoepidemiology where she was involved in studies using the GPRD database and was at one time on the management board of GPRD. She has an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine.
In 1997 she joined the European Medicines Agency. Following the first re-structuring of the EMEA, she became a Specialised Group in the pharmacovigilance, post-authorisation safety and efficacy sector. From May 2004 – September 2009 she was the EMEA risk management co-ordinator and was lead author of the EU risk management guideline. Since September 2009 her role involves developing the Agency’s policy and procedures for risk management as well as being heavily involved in PROTECT and other scientific projects. She is on the Steering Group for the European Network of Centres of Pharmacoepidemiology and Pharmacovigilance.
She was involved in setting up the Pharmacovigilance and Pharmacoepidemiology course at the LSHTM where she is an honorary lecturer, and was Deputy Academic Registrar on the Board of the Faculty of Pharmaceutical Medicine for four years. She is a Fellow of the Royal College of Physicians of Edinburgh, the International Society of Pharmacoepidemiology and the Faculty of Pharmaceutical Medicine. She is currently President Elect of ISPE.
Dr. Sarah Frise holds a Masters Degree in Physiology and Phd in Epidemiology from the University of Toronto. She currently holds the position of Director, Patient Safety and Medical Information at AstraZeneca Canada. This group has overall responsibility for all Canadian ADR reporting in clinical trials and marketed use, preparation of patient risk management plans and provision of medical information to patients and health care professionals using AstraZeneca Products. Sarah is a member of Expert Advisory Group on the Pharmacovigilance of Health Products.
Claudia Manzo is the Director of the Division of Risk Management in FDA’s Office of Surveillance and Epidemiology (OSE). In this role she directs and coordinates the OSE’s Risk Management Program which functions to review, advise or develop, and evaluate risk minimization strategies for products regulated by CDER. Claudia received her doctoral degree from the University of Tennessee, after which she completed a residency in clinical pharmacy practice at the Regional Medical Center in Memphis and a fellowship in Nutrition Support at the Philadelphia College of Pharmacy and Science. Claudia has been with the FDA since 1998 as a Postmarketing Safety Evaluator, Safety Evaluator Team Leader, and Team Leader Risk Management prior to taking on her current position. Prior to joining FDA she was a clinical pharmacist at Walter Reed Army Medical Center and a pharmacy officer in the US Army.
Denis Lebel is a practicing pharmacist at Sainte-Justine Hospital Center in Montreal, as well as having teaching and research responsibilities. His areas of interest are pharmacy practice and therapeutic risk management in the paediatric population.
Adrian R. Levy is Professor and Head, Department of Community Health and Epidemiology at Dalhousie University. He holds a PhD from McGill University (Montreal, QC) in epidemiology and post-graduate training at McMaster University (Hamilton, ON) in economic evaluation. In the early 1990s, he worked on the secretariat of the Conseil d’Évaluation des Technologies de la Santé du Québec. After completing his postdoctoral fellowship, he joined the faculty of the University of British Columbia (UBC) in July 2000. During nine years at UBC, he held BC Michael Smith Foundation for Health Research Scholar and Senior Scholar awards and a Canadian Institutes of Health Research New Investigator award. His academic interests in health services research include health technology assessment, comparative effectiveness research, pharmacoepidemiology, and pharmacoeconomics.
Yola Moride has received an MSc in Genetics and a PhD in Epidemiology from McGill University, as well as a Post-doctoral Fellowship in Pharmacovigilance from the University of Bordeaux. Yola has pursued an academic career in pharmacoepidemiology and therapeutic risk management, and for the past 16 years has been a Professor at the Université de Montréal and Visiting Professor at the University of Bordeaux. Recently, she became Researcher at the University of Montreal Hospital Center (CRCHUM). She is also President of YolaRx Consultants, a private organization that provides consultancy services to the pharma industry and regulatory agencies. In 2007-2008 she was President of the International Society for Pharmacoepidemiology (ISPE) and currently serves on the Board of Directors of the International Society of Pharmacovigilance (ISoP).. She is a member of advisory panels at Health Canada and the World Health Organization (WHO). She is on the Steering Group for the European Network of Centres of Pharmacoepidemiology and Pharmacovigilance (ENCePP) at the European Medicines Agency (EMA).
Yola was Chair of the 1st and 2nd Canadian Symposium on Therapeutic Risk Management (respectively, in 2006 and 2009). She will also be Local Host and Program Chair of the 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) to be held in Montreal in August 2013.
Dr White-Guay is a physician and holds specialty certification in both public health and family medicine.He has worked over 23 years in R&D in the pharmaceutical industry and his most recent position was Vice-President at Merck &Co in the USA. Following his retirement from Merck, he joined the Faculté de Pharmacie de l’Université de Montréal in October 2008 where he is currently professor and head of the BSc program in Biopharmaceutical Sciences :
His research interests are in drug development as well as safety and effectiveness assessment and medicines regulation.He is an active consultant in the US and Canada and is also affiliated with the CHUM, a university hospital in Montreal,Quebec.