Review of the Regulatory Affairs Professionals Society (RAPS) Global Regulatory Strategy Conference

Held in Baltimore, MD on March 6-7, 2024

The Regulatory Affairs Professionals Society (RAPS) is an organization that serves the needs of regulatory professionals in the pharmaceutical, biologics and medical device fields.  Every year, RAPS hosts a large conference (RAPS Convergence) that attracts thousands of regulatory professionals.   RAPS also administers the Regulatory Affairs Certification (RAC) program that allows regulatory professionals to become certified in a particular market (e.g. US), globally, or for a particular product type (e.g. RAC device).

This year, based on member feedback, RAPS organized, for the first time, a small, intimate Global Regulatory Strategy Conference.  There were approximately 100 attendees, split evenly between pharma/biologics and medical device professionals.  The conference was held outside of Baltimore, MD on March 6-7, 2024.  As with RAPS Convergence, the conference had parallel pharma/biologics and medical device tracks. RAPS plans a Regulatory Intelligence conference at the same location in June.

Since I was a speaker at the conference and the conference was local for me, I attended it.  The intimate nature of the conference allowed for effective and personal networking.   I stuck to the medical device side.  Since I typically work with small and medium sized companies in my consulting practice, it was fascinating for me to talk with professionals from large medical device companies and learn about their challenges.  

Representatives from FDA and the notified body TUV SUD were also in attendance. 

One challenge that I and other speakers had at this conference was injecting the “Global” into our presentations.  My presentation, on IVDs, focused primarily on the US and EU.  Other presentations were very US focused, although we did hear talks about the Canadian and EU regulations.  There was very little discussion about Asia-Pacific.  We did hear about a broad range of topics, however, including cybersecurity, standards, and modeling of real-world evidence as well as general strategies for communication with internal and external stakeholders. 

A couple of ways I think the conference could be improved:  1) it could be a little bit larger.  My IVD talk was sparsely attended (there were really only 2-3 IVD-focused professionals at the meeting).  The cost of the meeting was significant, which limits attendance from small-company RA professionals.  2) The location was not ideal– it was close to the airport but far from downtown Baltimore.  Having the meeting in the downtown Baltimore area could be more of a draw for attendees – we are very proud of our downtown and our playoff-caliber Orioles and Ravens (although this would likely make the conference more expensive, which would detract from trying to lower the cost of the meeting).  

I would definitely consider attending a small RAPS conference in the future - frankly being a speaker is a great way to defray the cost of the registration.  The conference had quite a different feel from Convergence and I’d like to see where RAPS goes with this new program.