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Ottawa Marriott Hotel

Oct 18, 2016 8:00 AM - Oct 19, 2016 4:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting 2016

Explore how innovation can support new initiatives, regulatory processes, research, transparency, engagement, personalized medicine, and use of real-world data in Canada.

Session 6 Track A: Policy Development and Direction

Session Chair(s)

Deirdre  Cozier

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)

Jane  Mitchell

Health Policy Initiatives: Ideas Becoming Official Policy and Beyond

Jane Mitchell

Mapi Life Sciences Canada Inc, Canada

Associate Director, Regulatory Affairs

Keith  McIntosh

Stakeholder Involvement in Guidance Development

Keith McIntosh

Innovative Medicines Canada, Canada

Executive Director, Scientific & Regulatory Affairs

Linda  Bowen, MSc, RAC

Speaker

Linda Bowen, MSc, RAC

Temple University Pharmacy School, United States

Assistant Adjunct Temple University

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