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Virtual Event

Oct 21, 2020 10:25 AM - Oct 22, 2020 4:15 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Canadian Pharmacovigilance and Risk Management Conference

Session 3: Canada Vigilance

Session Chair(s)

Marcia  Bailey, BSN, MHS, RN

Marcia Bailey, BSN, MHS, RN

Safety Evaluation and Risk Management Scientific Director

GSK, Canada

Deborah  Danoff, MD, FRCPC

Deborah Danoff, MD, FRCPC

Medical Evaluator

Health Canada, Canada

With many increasing health care and drug safety challenges, a good understanding of recent and evolving regulatory requirements and guidance will be important in maintaining patient safety in today’s climate. In this session, strategies in safety data collection, mandatory reporting, and in managing duplicate reports will be discussed.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand updates related to the ICH E19 Guideline and its impact on Industry
  • Identify methods to help reduce duplicate reports in the Canada Vigilance Adverse Reaction Online Database
  • Describe important factors involved in the Implementation of Vanessa’s Law

Speaker(s)

Bernard  Ogbiti, DrMed

Canada Vigilance Database Duplicate Cases – Industry Challenges

Bernard Ogbiti, DrMed

Methapharm Inc, Canada

Manager Medical Affairs

Gayatri  Jayaraman, PhD, MPH

Assuring Complete and Accurate Adverse Reaction Reporting-Moving from Good to Best

Gayatri Jayaraman, PhD, MPH

Health Canada, Canada

Director, Marketed Health Products Directorate

Heidi  Levens, MSc

ICH E19 Guideline – An Industry Perspective

Heidi Levens, MSc

Bristol-Myers Squibb Company, Canada

Head of Canada, Patient Safety

Fannie  St-Gelais, PhD

ICH E19 Guideline Updates

Fannie St-Gelais, PhD

Health Canada, Canada

Manager, Health Product and Food Branch

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