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Ottawa Marriott Hotel

2018 年 10 月 29 日 7:00 上午 - 2018 年 10 月 29 日 5:30 下午

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

Canadian Pharmacovigilance and Risk Management Strategies Conference


Marcia  Bailey, BSN, MHS, RN

Marcia Bailey, BSN, MHS, RN

Safety Evaluation and Risk Management Scientific Director, GSK, Canada

Marcia is a registered nurse with many years of clinical and industry experience. In addition to her past role as a clinical research data management subject matter expert, more than a decade of pharmacovigilance duties has helped Marcia acquire much of the knowledge, skills, and abilities needed to help companies manage today’s evolving drug safety responsibilities and regulations. Marcia has been a DIA conference speaker and is currently a Safety Evaluation & Risk Management Scientific Director at GSK.

Rita  Cassola, RPh

Rita Cassola, RPh

Executive Director PV, Certus PV Services Inc, Canada

Rita Cassola is an Executive Director of Pharmacovigilance at Certus PV Services Inc. Rita is a registered pharmacist with over 20 years of experience in global and Canadian pharmacovigilance. Rita’s experience includes over 10 years of senior PV consultancy and 10 years in increasingly senior PV roles within the pharmaceutical industry. Prior to joining the pharmaceutical industry, Rita spent 4 years in academia and 10 years in hospital pharmacy. Rita is engaged in teaching pharmacovigilance courses and has presented at several conferences/webinars organized by professional associations.

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, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has been a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within the Marketed Health Product Directorate (MHPD), as well as a member of the core team for the Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Since 2018 she has held the position of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate.

Marc  Poitras, PhD, MBA

Marc 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 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.

Rania  Mouchantaf, PhD

Rania Mouchantaf, PhD

A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada

Dr. Rania Mouchantaf is A/Executive Director at the Marketed Health Products Directorate at Health Canada with over 17 years of experience in the area of pharmacovigilance. Before entering the public service she worked in the private sector, however her interest in pharmacovigilance and public health led her to join the federal government at Health Canada where she has assumed different roles in assessment, management and strategic policy development from both a pre and post market perspective in the area of safety, efficacy and quality Her education includes a Bachelor degree in Microbiology and Immunology and a doctorate degree in Pharmacology and Therapeutics from McGill University.

Choo Pin  Por, PharmD, RPh

Choo Pin Por, PharmD, RPh

Manager, Global Pharmacovigilance Compliance, Apotex Inc, Canada

I joined Apotex Inc. in 2013 as Manager, Global Pharmacovigilance Compliance. My role is to monitor and ensure the compliance of the Pharmacovigilance (PV) processes and systems; Conduct Good Pharmacovigilance Practice audits at the Corporate and Affiliate levels, Business Partners and Third Party PV Service Providers; Develop and maintain the procedures and systems in support of the PV Compliance Program; Provide Quality support during Regulatory GVP Inspections and Business Partner Audits. Prior to joining Apotex, I was with Purdue Pharma Canada as Manager, Drug Information and Pharmacovigilance.

Tim  Appleby

Tim Appleby

Regulatory Compliance & Enforcement Supervisor, Regulatory Operations and Region, Health Canada, Canada

Tim Appleby is the supervisor for the national coordination of the Good Pharmacovigilance Practices (GVP) inspection program in the Health Product Compliance Directorate in RORB at Health Canada. His role is to oversee the support of Canada's national GVP inspection program by assisting in resolving emerging issues arising from inspections, liaising with the Marketed Health Products Directorate, contributing to the development of program regulations, policies, and guidelines.

Tarek  Hammad, MD, PhD, MS, MSc, FISPE

Tarek Hammad, MD, PhD, MS, MSc, FISPE

Vice President, Head of Medical Safety, Marketed Products, Takeda, United States

Dr. Tarek Hammad, VP & Head of Medical Safety for Marketed Products at Takeda Pharmaceuticals, is a renowned expert in drug safety, benefit-risk assessment, and pharmacoepidemiology. With extensive experience at major pharmaceutical companies like Sanofi and Merck, as well as a distinguished 13-year career at the US FDA, he has received numerous awards for his contributions. Dr. Hammad is a sought-after speaker, actively involved in industry initiatives and has held several academic appointments. He has authored over 80 peer-reviewed articles, book chapters, and letters to the editor, offering valuable insights in the field. Learn more at www.DrTarekHammad.com.

Gayatri  Jayaraman, PhD, MPH

Gayatri Jayaraman, PhD, MPH

Director, Marketed Health Products Directorate, Health Canada, Canada

Dr. Gayatri Jayaraman is the Director, Marketed Health Products Directorate at Health Canada. Prior to joining the federal government, she worked as a Public Health Program Consultant in East Africa, South Asia, and the Balkans. She is an adjunct professor in the School of Epidemiology and Public Health at the University of Ottawa. Dr. Jayaraman has co-authored over 100 publications is the proud recipient of the Public Health Agency of Canada’s Dr. Andres Petrasovits Award for Excellence in Public Health. She holds a PhD in Microbiology and Immunology from the University of Rochester, NY and a Master's of Public Health (Epidemiology/Health Policy) from Johns Hopkins University, Maryland.

Rhonda  Kropp, BSN, MPH

Rhonda Kropp, BSN, MPH

Director General, Marketed Health Products Division, Health Canada , Canada

Rhonda Kropp is currently the Director General for the Marketed Health Products Directorate in the Health Products and Food Branch of Health Canada. She has been working in health policy, programs and surveillance for over 20 years as a nurse, microbiologist, researcher and infectious disease epidemiologist. During her fifteen years with the Government of Canada, Rhonda has taken on a diversity of roles in the federal health portfolio in the areas of sexual health, travel health and infectious disease prevention and control before joining the regulatory environment. Rhonda was the proud recipient of the Chief Public Health Officer of Canada medal in 2017.

Tony  Lee

Tony Lee

Associate Director, CISO, Apotex Inc., Canada

Tony Lee is currently Manager of Privacy and Security at Apotex Inc. He has been in the pharmaceutical and healthcare industries for over 25 years. Starting as a chemist at Apotex, Tony switched into the IT world and worked at many roles before becoming Manager of Apotex's Data Centre. Tony left Apotex and spent time as IT Manager at Sunnybrook Health Sciences Centre in Toronto before returning to Apotex where his focus has been on privacy and information security for the last 10 years. Tony has a B.Sc in Biochemistry from the University of Waterloo and a B.A. in Computer Science from York University.

Bill  Wilson

Bill Wilson

A/Manager, Data Management and Integrity Section , Health Canada , Canada

Bill Wilson is the Acting Manager of the Data Management and Integrity Section at the Marketed Health Products Directorate of Health Canada. Bill has worked at Health Canada for the past 22 years. During his career, he has been involved in the pre-market review of drug submissions, but has spent the majority of his career working in the post-market surveillance of marketed health products, in the area of adverse reaction reporting. Bill graduated from Carleton University with a Bachelor of Science degree in Biochemistry and a Bachelor of Arts degree in Psychology.

Jacques  Le Lorier, MD, PhD, FACP

Jacques Le Lorier, MD, PhD, FACP

, Universite de Montreal, Canada

Dr. Jacques LeLorier is Full Professor at the University of Montreal’s Departments of Medicine and Pharmacology. Dr. LeLorier is a Member of the Canadian Institutes of Health Research (CIHR) Peer Review Committee, a member of the steering committee CNODES (Canadian Network for Observational Drug Effect Studies) and also Member of the Human Drug Advisory Panel (HDAP). He has published more than 235 Scientific Articles in Peer-Review Journals, and he is also the author of (1) book, and (6) Book Chapters. Dr. LeLorier is also a member of the Honorary Editorial Board of Journal of Clinical Epidemiology, Disease Management & Health Outcomes, Journal of Evaluation in Clinical Practice and Current Drug Safety.

Yola  Moride, PhD, FISPE

Yola Moride, PhD, FISPE

President, YolaRX Consultants, Canada

Prof. Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Research Professor at Rutgers University and President of YolaRX Consultants. She received a PhD in Epidemiology from McGill University and a Post-doctoral Fellowship in Pharmacovigilance from the University of Bordeaux (France). She was President of the International Society for Pharmacoepidemiology (ISPE) and Vice-President of the International Society of Pharmacovigilance (ISoP). She also served on the Steering Group of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) at the European Medicines Agency, and was a member of CIOMS Working Group IX on risk min.

Priscilla  Velentgas, PhD

Priscilla Velentgas, PhD

Senior Director, Science at Aetion, Aetion, United States

With 20 years of experience in pharmacoepidemiology research, Priscilla has led pharma and US Government funded research studies in CRO, academic and industry settings. Her prior roles include Global Scientific Head for Epidemiology at IQVIA, and faculty member in the Harvard Medical School Department of Population Medicine. She received her PhD in Epidemiology from the University of Washington School of Public Health and Community Medicine and is based in Aetion’s Boston, MA office.

Ravi  Deshpande, PharmD

Ravi Deshpande, PharmD

Senior Vice President, Specialty Health, McKesson Canada , Canada

Dr. Deshpande is Sr Vice President of Specialty Health at McKesson and a pharmacist. He held appointments at hospitals in Ontario and North Carolina and was Assistant Professor of Medicine at the University of North Carolina. Ravi founded a pharmaceutical services firm providing patient, prescription and consulting services for specialty drugs which was acquired by McKesson in 2005. He has worked with McKesson’s specialty businesses in the US and Canada and was instrumental in launching McKesson Specialty Health’s REMS (Risk evaluation and mitigation services) in the US, including launching the transmucosal immediate release fentanyl REMS.