Diving deep on global regulatory strategy at the newest RAPS event
Global regulatory strategy is a vital competency for regulatory professionals. This week at the first-ever RAPS Global Regulatory Strategy Conference, regulatory professionals gathered for an in-depth, interactive experience where attendees deepened their knowledge of multifaceted global regulatory requirements.
This conference, part of the newly launched RAPS Conference Series, provided mid- and senior-level regulatory professionals with the opportunity to learn from and with each other in an engaged and interactive setting.
Held in Baltimore, MD, attendees experienced an interactive, educational event featuring regulatory strategy presentations from industry experts and regulatory agency representatives.
“Global regulatory strategy is at the very heart of the regulatory affairs profession,” said Jethro Ekuta, vice president, regulatory affairs at Alexion Pharmaceuticals and president of the RAPS Board of Directors. “This conference enabled us to facilitate much-needed discussion on regulatory strategy to give attendees insights they can bring back to their employers.”
How — and why — RAPS created the Global Regulatory Strategy Conference
Mastering global regulatory strategy allows for smoother international market access, efficient product development, and competitive advantages. That’s why regulatory strategy is a crucial regulatory competency, and why RAPS created a conference where experienced regulatory professionals could focus on deepening their knowledge.
RAPS worked with regulatory professionals who possess extensive knowledge in global regulatory strategy to develop this event. The RAPS Education Committee curated the conference agenda to cater to mid- to senior-level regulatory affairs professionals.
An opening plenary provided ways to make regulatory affairs a strategic partner at your organization
Regulatory professionals worldwide have heard it all before.
Why should I invest in regulatory? It won’t make us any money.
Regulatory is just something we do once our product is ready to go to market.
At the conference’s opening plenary, regulatory experts imparted wisdom on strategies attendees can use to overcome these roadblocks and get buy-in for regulatory from their organizations.
A focused setting with educational sessions
The RAPS Global Regulatory Strategy conference agenda provided attendees with select sessions on regulatory strategy across two tracks: medical devices/in vitro diagnostics (IVDs) and pharma/biologics.
“I liked it. It seemed more personal, and it was easier to connect with people,” said Yelena Vaydman, senior regulatory affairs manager at Biologics Consulting.
“The gathering allowed for more personable conversations and discussions on cutting-edge topics,” said Joga Gobburu, professor at the University of Maryland. “Interacting with the speakers has been phenomenal."
Attendees who registered for “Project Management in Global Regulatory Affairs for Product Lifecycle Maintenance,” a workshop taking place the day before the conference, learned about the tools and mindset needed to conduct mid to large-scale projects in regulatory and achieve a global impact.
A closing plenary on AI and cybersecurity
At the closing session, MedSec CEO Michelle Jump, RAC, and Veeva Systems Senior Director, Global Government Affairs Amra Racic delivered advice on ways regulatory professionals can factor in two in-demand subjects: cybersecurity and artificial intelligence (AI), to their regulatory strategy plans.
At “How Cybersecurity and AI Have Changed the Regulatory Strategy Environment,” they gave advice on how cybersecurity and AI have changed approaches to regulatory submission strategy and expectations.
What’s next in the RAPS Conference Series
RAPS will return to Baltimore for the RAPS Regulatory Intelligence Conference on 6-7 June, with a preconference workshop on 5 June, where attendees will explore key regulatory intelligence topics more in-depth, within a collaborative environment promoting engaging education and professional development.
