New York / New Jersey & DC/ Baltimore Chapters: An FDA Review and What's Next for Regulatory Professionals in 2023

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Tuesday, 28 February 2023 (12:00 PM) - Tuesday, 28 February 2023 (1:30 PM) Eastern Time (US & Canada)

The FDA had a momentous 2022, with newly reauthorized user fee programs, a massive new package of legislative reforms, new and significant regulatory changes, and more. In this webinar, we will quickly review some of the biggest changes from 2022, and then identify which topics and trends regulatory professionals should be focused on in the year ahead. Key areas of focus will include:


January 25, 2023 — February 28, 2023 $0 Member | $25 NonMember

Learning Objectives

At the conclusion of this webcast, attendees should understand:

  • Changes happening in 2023 under the user fee reauthorization commitment letters. 
  • Recent legislative changes made under the Food and Drug Omnibus Reform Act (FDORA). 
  • FDA’s regulatory and guidance agenda for 2023 and key take-aways. 

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.

Who Should Attend?

Professionals working in regulatory affairs, regulatory compliance, quality assurance and quality compliance.


Mr. Alexander Gaffney

Mr. Alexander Gaffney

Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence at POLITICO’s AgencyIQ division where he leads the team’s research and analysis of regulatory issues affecting pharmaceutical, biotechnology, medical device and chemical companies. Alexander previously worked at the consulting company PricewaterhouseCoopers where he led analysis of life sciences regulatory issues for the firm’s Health Research Institute. Alexander was also the Manager of Regulatory Intelligence and Managing Editor at the Regulatory Affairs Professionals Society (RAPS) where he ran the company’s flagship publication, Regulatory Focus. Alexander is regularly asked to speak to executive audiences about regulatory policy developments and his work has been cited in Congress and by major media outlets and medical journals. He has a master’s degree in Regulatory Science and his Regulatory Affairs Certification(RAC) in US regulation


RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to  RAPS is unable to accept cancellations by phone.

To transfer a registration, email with the event title, name of the original registrant, and contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.



For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop

For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email

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