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  • Join us next week! - March 8, 2022 at 12 noon EST - A Gaffney on FDA Legislative Update

    Hold the Date - March 8, 2022 - 12 noon EST - RI WG Monthly Meeting - A Gaffney on FDA Legislative Update

    DIA Regulatory Affairs Community Regulatory Intelligence Working Group Monthly Meeting

    When: March 8, 2022 – 12 Noon EST

    Topic:

    FDA Legislative Update

    2022 is likely to be the busiest, most impactful year for FDA-related legislation in decades – and perhaps ever. Life sciences companies are facing the prospect of regulatory reforms from user fee legislation, pandemic legislation, drug pricing legislation, targeted reform legislation, and more. Already, Congress’ ambitions have taken shape in two distinct areas: User fee reform legislation and pandemic reform legislation. We’ll discuss specific legislative proposals, their prospects for passage, the problems they aim to solve, and how they might benefit (or challenge) life sciences companies.

    Speaker:

    Alexander Gaffney, MS, RAC – Executive Director, AgencyIQ

    Alexander Gaffney is the Executive Director of Life Sciences at POLITICO’s AgencyIQ, where he leads the team’s research and analysis of life sciences regulatory issues affecting the Food and Drug Administration. He also leads the team’s business development activities.

    Alexander previously worked at PricewaterhouseCoopers where he led the firm’s analysis of life sciences regulatory issues as part of its Health Research Institute. Before joining PwC, he was Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also was Managing Editor of the company’s flagship publication, Regulatory Focus. Alexander has a master’s degree in Regulatory Science from the University of Maryland and has held his Regulatory Affairs Certification (RAC) in US regulation since 2013. He also has a degree in Political Science from Providence College. He currently lives in the Washington, DC area with his wife and two dogs.

    This meeting will NOT be recorded.

    RARegIntell WG is inviting you to a scheduled Zoom meeting.

    Time: Mar 8, 2022 12:00 PM Eastern Time (US and Canada)

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