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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand recording from December 2022.
What will the FDA do in 2023? In this timely, lively and informative event, regulatory analysts from POLITICO's AgencyIQ will explain what regulatory professionals should anticipate in the year ahead based on emerging trends, known issues, regulations and guidance documents and more.
Attendees of this session will come away with a better understanding of what FDA is working on, why they're working on it, and the potential impact that future actions may have on their business.
All regulatory topics discussed during this event will be about or directly related to the pharmaceutical, biopharmaceutical, biotechnology, medical device, diagnostic and dietary supplement sectors.
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.
Regulatory intelligence and policy professionals; Regulatory strategy professionals; Regulatory professionals interested in being proactive in anticipating regulatory actions.
Speakers:
Alexander Gaffney
Executive Director, Life Sciences
POLITICO'S 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. 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 publication, Regulatory Focus. Alexander has maintained his Regulatory Affairs Certification (RAC) in US regulation since 2013, and also received his master’s degree in regulatory science from the University of Maryland.
Laura DiAngeloSenior Manager, POLITICO’s AgencyIQ
Laura DiAngelo is a Senior Research Manager on the AgencyIQ team. She contributes to the research and development of content for Agency IQ. 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 a MPH in health care policy from the George Washington University’s Milken School of Public Health, as well as a BA from Binghamton University. Laura lives in Washington DC, and enjoys the work of the Washington National Opera and the Washington Capitals.
Kari OakesPOLITICO's AgencyIQ