Already a DIA Member? Sign in. Not a member? Join.

Iniciar sesión

¿Ha olvidado su ID de usuario? or ¿Ha olvidado su contraseña?

Not a Member?

Create Account and Join

Ottawa Marriott Hotel

17 oct 2017 7:00 a.m. - 18 oct 2017 3:00 p.m.

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

Session 6C: Postmarket Considerations: Including PV Inspections, Global Drug and Device Challenges, and Vanessa’s Law

Session Chair(s)

Lorella  Garofalo, PhD

Lorella Garofalo, PhD

Head of Regulatory Sciences

Pfizer Canada, Canada

Amendments to the Canadian Food and Drugs Act under Bill C-17 have resulted in a broadening of Health Canada’s (HC) powers in particular concerning the collection of post-market safety information. This session will provide an overview of the ongoing modernization and renewal efforts being undertaken by Health Canada on its Good Pharmacovigilance Program (GVP) inspection program and in addition discuss recent trends in GVP inspections. An update by HC on Bill C-17 related regulations and the Industry perspective on the impact, benefit and cost of implementing Bill C-17 requirements based on current proposals will also be presented.

Speaker(s)

Sophie  Lafrance

Updates on the Good Pharmacovigilance Practices Inspections

Sophie Lafrance

Health Canada, Canada

Corporate Regulatory Compliance & Enforcement Advisor

Rocelyn  DelCarmen

Vanessa's Law - Costs and Benefits of Implementation

Rocelyn DelCarmen

Astrazeneca Canada Inc., Canada

Director, Regulatory Affairs and Quality Assurance

Debra  Haltrecht

Vanessa’s Law – Update on Implementation

Debra Haltrecht

Health Canada, Canada

¿Tiene una cuenta?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.