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Session 6 Track A: Policy Development and Direction
Session Chair(s)
Deirdre Cozier
Director, Global Regulatory Affairs
Pharmascience, Canada
Policy development allows regulators to communicate their interpretations of legislation and clarify expectations of the industry. It is also an opportunity for industry stakeholders to help shape the regulatory framework in which we operate. This session will overview the process of policy development at Health Canada, from conception to finalization. It will include presentations from industry on the engagement of stakeholders and thought leaders, such as patient groups and industry associations, and the different models used to interact with these groups. Additionally, we will discuss how individual companies (from small and medium sized firms to the large multinational enterprises) can contribute to policy development at the local and international level by implementing innovative regulatory intelligence processes and tools.
Learning Objective : 1. To identify examples of key HC policy initiatives from past 5-10 years and describe the main triggers/ ideas for these and their development. 2. To describe roles that Canadian regulatory professionals and other individuals and parties play in initiating, developing, and advocating HC policies now and in the foreseeable future.
Speaker(s)
Health Policy Initiatives: Ideas Becoming Official Policy and Beyond
Jane Mitchell
Mapi Life Sciences Canada Inc, Canada
Associate Director, Regulatory Affairs
Stakeholder Involvement in Guidance Development
Keith McIntosh
Innovative Medicines Canada, Canada
Executive Director, Scientific & Regulatory Affairs
Speaker
Linda Bowen, MSc, RAC
Temple University Pharmacy School, United States
Assistant Adjunct Temple University
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