Convergence 2023 to focus on the future of the regulatory professional

The last few years have seen unprecedented change in regulatory affairs through the impacts of the COVID-19 pandemic, a transforming regulatory environment, anticipated and unanticipated delays, and other changes. This year’s RAPS Convergence will focus on taking what regulators have learned from these changes to prepare for the future of the profession.

“It reflects a culmination of prior years,” Kimberly Belsky, MS, FRAPS, chair of the RAPS Convergence Planning Committee, told Focus. The plenary sessions reflect this look to the future, with sessions on artificial intelligence (AI), psychedelics, and patient-centered health.

In particular, Belsky said the session on psychedelics highlights the RAPS focus on the future of the regulatory professional since psychedelics are Schedule I drugs for which the US Food and Drug Administration (FDA) has found no therapeutic benefit, yet are being discussed at the conference. “If we come into ideas with a closed mind, we're going to miss it,” Belsky said.

The conference will be held 3-5 October at the Palais des Congrès de Montréal in Montreal, Quebec, Canada.

Regulatory affairs can be a fast-changing world, said João Duarte, a RAPS Committee Member who is senior director of regulatory affairs at Alexion, AstraZeneca Rare Disease. That means regulatory professionals need to understand how the profession is being modernized and gain new skills to understand the impact of AI, digital health, and new systems and tools. Learning these skills will help make the work of both industry and regulators better, he said.

Another major theme for Convergence this year is regulating complexity, Duarte explained. “When we see new modalities such as mRNA or advanced therapies, drug-device combinations, digital health, there are more and more challenges popping up here and there,” he said.

Attendees can expect discussions on how well complexity is being regulated “in a pragmatic and hopefully consistent way so that we ensure that the role that we play as regulatory professionals is still seen as positive rather than creating hurdles and challenges for the future,” Duarte said.

The conference will also feature sessions on Prescription Drug User Fee Act (PDUFA VII), advancing health equity, orphan drug development, and clinical trial diversity, among other topics.

Sessions with regulators

As in previous years, RAPS Convergence 2023 attendees will have opportunities to engage with health authorities in a set of sessions titled “Conversations That Matter.” While this isn’t a forum to ask product-specific questions, it is a chance to get in front of a regulatory officials from the FDA, European Medicines Agency, Health Canada, and other health authorities to discuss drugs, biologics, combination products, medical devices, and in vitro diagnostic devices.

“[Y]ou never get too many opportunities to interact with regulators in this type of forum,” said Jethro Ekuta, DVM, PhD, RAC, FRAPS, president of the RAPS Board of Directors and vice president, head of regulatory affairs marketed products at Alexion, AstraZeneca Rare Disease. “This is just a unique forum that allows people to have that access to the best health authorities around the world and be able to interact with them and ask any questions they have.”

Duarte said sitting in on these sessions is a key aspect of attending a Convergence conference and an “amazing opportunity to learn from regulators.”

“When regulators come,” Duarte said, “regulatory professionals better listen, because they are outlining the priorities for the agencies, outlining new processes, outlining their new challenges that they want to solve collectively.”

Networking opportunities

All the RAPS Convergence Planning Committee Members interviewed said attendees should take the opportunity to meet with regulators and other attendees in person, whether that be sitting next to someone at a lunch table, attending a Solutions Circle or Conversation Starters session—or even stopping someone for a chat in a hallway.

“Convergence isn't just about attending a session, it’s really about leveraging those opportunities to speak to other people, listen—that includes exhibitors, that includes everybody that's there,” Belsky said.

Duarte said he finds it easy to network at the conference. “I've always found that RAPS Convergence is a very safe environment and a very exciting environment for any person or type of personality to engage with, because you find a lot of people doing a lot of the work that you do every day,” he said.

In Ekuta’s view, every interaction is an opportunity for networking at Convergence. “You never know what those networking opportunities can bring about in the future,” he said.

How can attendees make the most from the conference? Ekuta said it is all about making a plan ahead of time while still remaining flexible. Actively participating during sessions, whether that means asking questions or contributing knowledge, will go a long way toward helping attendees feel more connected to the conference.

“My hope is that they will feel inspired about the future of the regulatory profession, to see themselves as being very fortunate to be members of this profession, which is only continuing to grow and with a lot of great things ahead of it in terms of contributing to the public health,” he said.

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Convergence 2023 to focus on the future of the regulatory professional

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