Sponsored Webcast: FDA Forecast 2021: What changes are in store for FDA and industry in the new year?

1.5
RAC Credits
Virtual Programs Virtual Programs
Tuesday, 15 December 2020 (12:00 PM) - Tuesday, 15 December 2020 (1:30 PM) Eastern Time (US & Canada)

The FDA and life sciences industry have been tested like never before by the coronavirus pandemic. The FDA faces a significant number of regulatory challenges, disruptions, changes and opportunities as it looks ahead to 2021 with a new presidential administration. 

In this 90-minute webcast, AgencyIQ’s research team will guide participants through their FDA Forecast – The 10 FDA Regulatory Topics Slated to Have the Most Significant Impact on Regulated Industry in the New Year. Join researchers Alexander Gaffney, MS, RAC, Kedest Tadesse, MS, RAC and Laura DiAngelo, MPH as they explain each issue and its potential implications. This webcast will help attendees plan their regulatory strategy for the next 12 months and provide insight into what a new year and new leadership might mean for the FDA.


Audience Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


Learning Objectives:

Upon the conclusion of the program you will be able to:

  • Understand the FDA’s regulatory priorities for the coming calendar year
  • Identify potential impacts of these priorities on a wide range of regulatory functions
  • Identify strategic opportunities and threats from the range of potential regulatory outcomes


Who Should Attend:

  • Regulatory policy and intelligence professionals
  • Regulatory professionals interested in pharmaceuticals, biologics, medical devices, diagnostic products, non-prescription products, generics, biosimilars and dietary supplements.


Speakers:

Alexander Gaffney is the Head of Research at POLITICO’s AgencyIQ, where he leads the team’s research and analysis of life sciences regulatory issues affecting the Food and Drug Administration. 

Alexander previously worked at PricewaterhouseCoopers where he led analysis of life sciences regulatory issues for the firm’s prestigious Health Research Institute. Before joining PwC, he was the Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also was Managing Editor of the company’s flagship online publication, Regulatory Focus. Alexander earned Masters Degree in Regulatory Science from the University of Maryland and his Regulatory Affairs Certification (RAC) in 2013.

Laura DiAngelo is a senior research manager on the AgencyIQ team where contributes to the research and development of content for AgencyIQ. Before joining POLITICO, Laura consulted on policy and regulatory issues for life sciences and health plan clients with Avalere Health, and managed content for the Avalere Policy and State Reform 360® business intelligence research products. She holds an MPH in health care policy from the George Washington University’s Milken School of Public Health, as well as a Bachelor’s of Arts from Binghamton University.

  • Kedest Tadesse, MS, RAC, senior research manager, AgencyIQ

Kedest Tadesse is a senior research manager and contributes to the research and development of content for AgencyIQ. Prior to joining POLITICO, Kedest worked on issues related to the development, regulation, and litigation of foods, drugs, and medical devices, coordinating and compiling regulatory submissions to the FDA. Kedest also provided support in responding to various legislative challenges to consumer and industrial products. Kedest holds a Regulatory Affairs Certification (RAC), a Bachelor’s of Science in Biochemistry and Cell Biology from Jacobs University (Bremen, Germany) and a Master’s of Science in Biotechnology from Georgetown University (Washington, DC).


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