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Regulatory Focus – What to expect at Convergence 2022

Regulatory Focus – What to expect at Convergence 2022

Convergence 2022 is back in person in Phoenix, AZ, with updates from US regulators and health authorities around the globe, career transitions and professional development sessions, and wellness breaks.

Members of the RAPS Convergence Planning Committee said they wanted to provide a variety of options for attendees, with content that tackles the regulatory challenges beyond the COVID-19 pandemic.

“We’ve talked about the pandemic, and we’ve talked about the lessons learned,” said Megha Deviprasad Iyer, RAC, of Thermo Fisher Scientific, and co-chair of the RAPS Convergence Planning Committee. “What is the common theme? It’s science.”

“We’ve got to continue to advance science in all the other areas, even beyond COVID,” she said.

With that in mind, the conference features sessions on utilization of real-world evidence, the future of vaccine regulatory pathways, the role of artificial intelligence in medical devices, developing decentralized clinical trials and moving forward with innovative manufacturing.

RAPS Convergence will be held at the Phoenix Convention Center from 11-13 September 2022.

Engaging regulators

Attendees looking to hear directly from regulators should check out the Health Authority Forums, said Kimberly Belsky, FRAPS, of Mallinckrodt Pharmaceuticals, and co-chair of the RAPS Convergence Planning Committee. “That is where you get to hear from them what is on their minds.”

The conference features five of these forums, with presentations from regulators from the European Medicine Agency (EMA), the Austrian Agency for Health & Food Safety (AGES), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and Drug Administration (FDA).

Convergence 2022 also includes a session on how to resolve disagreements with the FDA during pre-market review. The session, called “With All Due Respect, We Disagree with FDA’s Assessment,” includes speakers from the agency’s ombudsman programs. Iyer, who is moderating the session, said FDA officials proposed the topic. “They want to educate us on the routes that are available to people to lodge that disagreement in a constructive manner.”

Focus on patients

This year’s Convergence also includes sessions dedicated to patient-focused drug development.

One session, on Monday, 12 September, examines how the IMI-PREFER recommendations and CHMP methods qualification opinion will impact patient-centric drug development. Another, on Tuesday, 13 September, examines the future of patient experience data in global drug development. The plenary session on 13 September will celebrate Friends of Cancer Research, which is the recipient of the 2022 Patient-Centered Health Award.

Belsky said she is excited about the focus on patient-centered drug development at this year’s committee. “Why do we do this? It’s all about the patient and understanding where regulators and industry are going and need to go is key,” she said.

Building skills

Belsky said the Convergence agenda also features opportunities for attendees to gain some professional development during Skill Building sessions (color coded in yellow on the program). These sessions include tips for improving public speaking skills, best practices for identifying relevant regulatory intelligence and even a session on working for the FDA.

The 12 September Plenary session will focus on career transitions, with a panel of regulatory professionals at various career stages discussing their journeys.

With acquisitions and job changes, careers are not often linear in regulatory affairs, Belsky said, so Convergence offers a chance to sample a variety of content that might be outside a professional’s typical responsibilities. “One of the things that I always encourage people to do is to step outside their comfort zone. Go to some session that they normally wouldn’t and learn something new,” she said.

Building a network

With Convergence coming back in person, the conference is also a chance to make connections and rekindle professional relationships that have been virtual for the last two years.

Erin Oliver, RAC, FRAPS, of Haleon, and a member of the planning committee, said one of the big draws of Convergence is the chance to create and cultivate a network of trusted experts. And while that was possible to do virtually, it was more difficult. “It is just so much easier in person to make those initial connections and then to continue to build them offline. That’s why I’m really excited to be back in person to continue to build those bridges, to make those connections in ways that you just can’t do virtually.”

Bassil Akra, PhD, CEO of Akra Team GmbH, who also serves on the planning committee, said he has participated in several conferences and trainings virtually but that the experience falls short of being in person. He said he is looking forward to those informal moments that can’t be replicated online.

“The benefit of conferences are not just the presentations,” he said. “The most important piece is not when you give a speech but after that speech, people coming to you and saying, ‘Can I have five minutes of your time because I have a challenging point?’ They would not do it in a virtual world.”