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Health Policy Initiatives: Ideas Becoming Official Policy and Beyond

May 18, 2017 @ 10:00 - 11:00 UTC+0


Webinar Topic:

Health Policy Initiatives: Ideas Becoming Official Policy and Beyond

Webinar Date:

Thursday, May 18, 2017 @

10 - 11 AM EST (NYC, USA)

Webinar Host:

Jane Mitchell, PhD, RAC - Associate Director, Regulatory Affairs at Mapi Group (Mapi Life Sciences Canada Inc. / Dundas, Ontario, Canada)

* Connect with Jane on LinkedIn: https://www.linkedin.com/in/e-jane-mitchell-ph-d-rac-u-s-can-252b9862

Jane has broad experience, in biotech and consulting for 15+ years. Jane's expertise includes early drug development, regulatory affairs, project management and electronic regulatory information management (RIM). Jane has a PhD from the University of Toronto in Biochemistry and Cell Biology. Jane "postdoc'd" at the Laboratory of Molecular Biology (Cambridge, UK) and she worked at NRC's Biotechnology Research Institute (Montreal) for several years in the receptor group. Jane is a member of DIA, RAPS, CAPRA and CSPS and an author for the RAPs publication Fundamentals in Canadian Regulatory Affairs. Jane has a particular interest in policy and regulatory sciences.

Presentation Description:

Health policy initiatives, intended to maintain and improve the health of Canadians, take root in multiple ways. This session will explore how ideas for policy initiatives get started, what processes, formal/informal they typically go through, including whether they evolve slowly over time or quickly in response to something unexpected (e.g., Zika virus). An initiative may evolve considerably for many years before a Bill is finally passed in Parliament, e.g., Vanessa’s Law. Ideas can come from individuals, advocacy groups, media, industry, industry organizations, partisan policy processes, and government agencies, for example.

Other Departments may trigger policy initiatives, e.g., DND and EUNDS. Other levels of government or international initiatives may also trigger policy.As example, the proposed drug benefit changes impacts provincial formularies. Clarification of existing policy may be in order, e.g., the New Guidance in 2015, Drug Submissions relying on 3rd Party-Data, as a comparison to a foreign agency. Policy may be initiated through “petitions” and industry can indirectly influence policy during product reviews/transactions with HC. Industry groups, companies, and associations including DIA/CAPRA, often provide input during the process of finalization and perhaps this is the most visible input regulatory professionals play in response to HC consultation.

As the future unfolds, new policy ideas and development are needed as HC moves further into overseeing the development of novel products e.g., genomics, nanotechnologies, robotics. An understanding of effecting policy initiatives and policy development processes is increasingly important in order that key thought leaders, and key groups contribute knowledgeably and thoughtfully to policy development. Recent examples of policy initiatives, their development and updates on these will be presented and discussed.

Health policy initiatives take root in multiple sources and many triggers drive policy development. As HC moves to oversee innovative products, key thought leaders and groups are needed to engage knowledgeably and thoughtfully in policy processes. Learn more during this live webinar event.

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May 18, 2017
10:00 - 11:00
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