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Plenary Session 2: Stakeholder Perspective

Plenary Session

Day & Time:
October 29, 11:00AM - 12:30PM


Plenary Session 2: Stakeholder Perspective

Chanez-Narimene Kebache
Manager, Pharmacovigilance
Mallinckrodt Pharmaceutical, Canada

Matthew Ryan
Senior Advisor, Director General's Office, Therapeutic Products's Directorate
Health Canada, Canada

In today’s reality, companies are doing business internationally. While they are seeking to bring their products to global markets with unified research and development approach, they are facing national laws and diversified regulations and requirements in both the R&D phase as well as in the post approval surveillance and commercialization phase. After the regulator’s perspective, this plenary session will give an opportunity to industry representatives from different businesses to brief the audience on the involvement of stakeholders in the regulatory harmonization process, what are the challenges to face, the opportunities to focus on and how it may impact their future.

Presentation(s) & Speaker(s):
Regulatory Harmonisation – Industry Perspective
Peter K. Honig, MD,MPH
Vice President and Head, Global Regulatory Affairs and Patient Safety
AstraZeneca Pharmaceuticals LP, United States

International Regulatory Cooperation: Trends and Impacts for Academic SponsorsRegulart
Alison Urton
Investigational New Drug Program and Audit and Monitoring Group
NCIC Clinical Trials Group, Canada

A Survivor's Story
Norma Beauchamp
Breast and Thyroid Cancer Patient Experience Advocate
Patient Advocate, Canada

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