Convergence 2024 to explore AI, workplace challenges, unmet medical needs

This year’s RAPS Convergence conference focuses on leveraging artificial intelligence (AI) and other digital technologies by recognizing the essential role of humans in the successful implementation of these tools.

The theme, “Human in the Lead,” was chosen to highlight AI as a tool for efficiency that cannot fully replace human intelligence and knowledge, explained Megha Deviprasad Iyer, RAC, FRAPS, Director of Global Strategic Regulatory Affairs at Thermo Fisher Scientific and Chair of the RAPS Convergence Planning Committee.

“We really wanted to empower our regulatory community to look at AI as an important tool for collaboration,” Iyer said. “We don’t want people to feel scared of AI.”

The opening plenary session, to be held on 17 September, will feature experts from across industry and government who have successfully integrated AI solutions. Additional sessions throughout the conference will touch on ensuring data quality and privacy in AI-enabled medical devices, monitoring of AI devices, and precision medicine involving AI and machine learning (ML) modeling.

The goal is for attendees to come away from Convergence with some ideas on how AI can add value to their work in regulatory affairs, said Jethro Ekuta, RAC, FRAPS, Vice President of Regulatory Affairs at Alexion, AstraZeneca Rare Disease and President of the RAPS Board of Directors. “Everybody wants to really see how they can apply AI into their day-to-day work processes,” he said.

RAPS Convergence will be held at the Long Beach Convention & Entertainment Center in Long Beach, CA., from 17-19 September. The conference features session tracks on biopharmaceuticals, devices, health authority sessions, broad interest and skill building, and Solution Circles.

Session highlights

The plenary session on 18 September will focus on challenges in developing medical technologies for unmet medical needs across therapeutic areas. The session will include successful case studies as well as tips for navigating global regulations and post-market surveillance.

“We’re talking more about unmet medical needs because that is truly what drives a lot of regulatory affairs professionals,” Iyer said.

She pointed to a session on addressing menopause, to be held on 19 September, as one example of an unmet medical need that is starting to get more attention. The menopause session will highlight the growing global population of menopausal and postmenopausal women – estimated to hit 1.2 billion by 2030 – and gaps in both understanding and treatment options. It will also explore some of the strategies and challenges of “femtech” startups working in this area.

Other hot topics that are being explored at this year’s Convergence include real-world evidence (RWE), drug shortages, the challenges for startups and spinoffs, as well as the latest guidance from the US Food and Drug Administration (FDA) on predetermined change control plans, and structured dialogues for in vitro diagnostic medical devices in Europe.

Evolving workplace challenges

The closing plenary session, to be held on 19 September, will focus on modern challenges and opportunities within the workspace. The expert panel, which includes both early and mid-career professionals, will share firsthand experiences on how they have navigated remote and hybrid work environments.

Iyer said the plenary will explore how early-career professionals can gain insights from more senior colleagues even when they aren’t in the office together. “Those things that you could learn through osmosis, that’s just not there,” she said. “Those watercooler conversations don’t look the same everywhere.”

This year’s Convergence features other career-focused sessions including “Progress Towards Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs” on 18 September and “Finding a Job in Regulatory Affairs or Regulatory Compliance: Skills for Success” on 19 September.

Regulator engagement

The participation of regulators from the US and across the globe is one of the unique aspects of Convergence and the 2024 conference continues that tradition. This year’s conference features an International Harmonization Forum on Thursday, 19 September with representatives from Botswana and Kenya, countries that have traditionally not been represented at Convergence.

Ekuta urged attendees to check out the “Conversations that Matter” sessions for both biopharmaceuticals and devices, which feature representatives from FDA, the European Medicines Agency (EMA), and other health authorities.

“Those are sessions that give the audience an opportunity to interact with representatives of regulatory authorities from many different agencies around the world in a very informal setting where people can ask pretty much any questions on their mind and know that they will get responses,” Ekuta said. “Those responses do not represent the official positions of the agencies they represent because this is an informal interaction but it’s usually a very good avenue to exchange information with regulators.”

Networking

To make the most of Convergence 2024, Iyer advised attendees to plan ahead by taking a look at the agenda and identifying sessions that will be relevant to work priorities over the next year and then adding a few sessions that may not be immediately relevant but that spark curiosity. She also suggested attending the plenary sessions and trying to make a couple of new friends at the conference. “That’s a good equation for a successful Convergence,” she said.

Susan Speicher, RAC, Director of Regulatory Affairs and Quality Compliance at Wolters Kluwer and a member of Convergence Planning Committee, said the program is designed to let attendees do a lot of things at once, whether that’s learning or networking. She pointed to Solutions Circles as one type of session where attendees can get a deep perspective on an issue while connecting with others interested in the topic.

Dine Arounds are another opportunity for attendees to form connections in an informal setting, Speicher said. “Network and find your people,” she advised.

Bassil Akra, CEO and Owner of AKRA TEAM, a globally acting consultancy company, and a member of the Convergence Planning Committee, advised attendees to take notes in every session and to connect with their neighbors during sessions by asking about their challenges and opinions. “It’s all about connection,” he said.

Convergence 2024 Agenda

Convergence 2024 to explore AI, workplace challenges, unmet medical needs

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