What are the biggest regulatory affairs trends in 2024?
Regulatory affairs is a field that has never stopped changing, but 2024 has thrown many curveballs our way.
From AI and the continued EU MDR and IVDR transitions to increased utilization of accelerated pathways and much more, it’s been a year full of challenges.
We asked a few of our RAPS Convergence 2024 presenters what they think is the biggest trend in regulatory affairs this year. Here’s what they said.
“Collaboration, collaboration, collaboration! Global convergence and collaboration are words I hear at every conference, and with good reason as we adjust to a post-COVID world. We are all at a turning point with the unique opportunity to work together to accelerate access to therapies worldwide through regulatory convergence, collaboration and technology, and I am so grateful to be a part of it.”
Ashley Jones-Mitchell
Director, Regulatory Innovation Strategy and Policy at Accumulus Synergy
Ashley is moderating FDA Forecast: What the FDA has Planned in 2025 for Pharmaceuticals and Biotechnology Products, a panel at RAPS Convergence 2024 on 18 September.
“There are still a lot of challenges around EU MDR, and as a small company interested in expanding our product line into Europe, I am very excited to attend a few sessions at RAPS around MDR challenges and to hear what solutions other attendees recommend for compliance. Cybersecurity also continues to be a hot topic of conversation with recent FDA guidance and eSTAR updates.”
Crew Weunski
Regulatory Affairs Lead at MediView XR Inc.
Crew is presenting Navigating Regulatory Pathways: When to Submit a Special 510(k) vs. Internal Letter-to-File for Device Changes, a session on 19 September.
“Considering my experience is focused on Brazil, I've noticed huge efforts of strengthening regulatory trust mechanisms and collaborative work between ANVISA and other regulatory agencies. Also, following the updates not only from Brazil, but also from other countries, we can see a general contribution to global regulatory harmonization.”
Patricia Luchiari Verrone
Regulatory Affairs Manager at Vera Rosas Group
Patricia is hosting a Solutions Circle, Submission of Implantable Medical Devices in Brazil: ANVISA's Class III and IV Requirements, on 19 September at RAPS Convergence.
“One major trend is the increased utilization of accelerated regulatory pathways for advanced technologies and gene therapies — along with a dramatic increase in collaboration between sponsors and regulatory agencies to maximize the efficiency of these accelerated pathways.”
Angela W. Corona, PhD
Senior Scientific Director, BOLDSCIENCE
Angela is presenting at Maximizing Opportunities to Engage with the FDA, a RAPS Convergence preconference workshop on 17 September.
“International regulatory harmonization, i.e. regulatory authorities in different regions aligning their technical requirements for drug development and evaluation as much as possible within national and regional legal frameworks, has definitely gained everyone's attention. Additionally, the use of artificial intelligence (AI) in regulatory affairs is gaining serious traction.”
Vidya Narayanaswamy
Program Manager, Integrated Project Management
Vidya is a moderator at Dive Deep: Navigating the Regulatory Maze of Concurrent Regulatory Submissions, a RAPS Convergence session on 18 September.
“The use of artificial intelligence in supporting all facets of regulatory affairs. AI has definitely come to stay, and we will all do well to learn how to leverage this powerful technology to simplify the work we do.”
Jethro Ekuta
Vice President, Regulatory Affairs at Alexion Pharmaceuticals
Jethro is speaking at Progress Towards Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs, a RAPS Convergence 2024 session on 18 September.
“Many new FDA initiatives.”
Michelle Pernice
Operating Partner at Fairmount Funds Management
Michelle is presenting at Using Innovative Regulatory Strategies to Streamline Drug Development – Real World Evidence, Platform Trials and Seamless Designs, a RAPS Convergence 2024 session on 18 September.
“In 2024, a significant trend in regulatory affairs is the increased emphasis on digital transformation and the integration of advanced technologies, such as artificial intelligence and machine learning, in regulatory processes. This shift is streamlining compliance, enhancing data analysis, and improving the overall efficiency of regulatory submissions and approvals.”
Parminder Kalle
Senior Director, Strategic Solutions at elemed
Parminder is speaking at Progress Towards Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs, a RAPS Convergence 2024 session on 18 September.
“Delays in submission due to budget cuts and delays of transitional provision period.”
Bassil Akra
CEO and President of AKRA TEAM
Bassil is presenting at Notified Body Forum: State of Play EU MDR and EU IVDR, a RAPS Convergence 2024 session on 18 September 2024.
“The intent to understand and regulate the contribution of AI on medical device and pharmaceuticals.”
Hagit Marchaim
Owner and Principal Consultant, HMC-regulation
Hagit is hosting Maximizing the Potential of Meetings with the FDA, a Solutions Circle session at RAPS Convergence 2024 on 18 September.
“Use of AI to save up resources.”
Andrea Biasiucci
CEO at confinis ag
Andrea is speaking at Addressing Menopause: From Unspoken Reality to Innovation Battlefield, a RAPS Convergence 2024 session on 19 September.
“I've noticed more questions from clients and FDA about cybersecurity, AI/ML, and interoperability of medical devices. I'm excited to swap notes with other regulatory folks to see what trends they've noticed this past year.”
Allison Komiyama, PhD, RAC, FRAPS
Vice President, MedTech Innovations at RQM+
Allison is speaking at Survivor: The FDA 510(k) Program Edition, a RAPS Convergence preconference workshop on 16-17 September.
“Because Philips has a long history of innovation in artificial intelligence, I am excited about how artificial intelligence-based tools could improve the efficiency of the regulatory professional.”
Josh Silverstein
Director of Regulatory Science and Policy, Philips
Josh is speaking at Basics of Regulatory Strategy for the US & EU, a RAPS Convergence 2024 preconference workshop on 17 September.
“Developing global industry standards and harmonization of regulations provide the clarity and stability to accelerate innovation. At a time when the delivery of healthcare is changing faster than ever before, there is a real opportunity to support the harmonization of global regulatory requirements.”
Lee Evans
Head of Global Regulatory Affairs, Philips
“Enhanced data analytics and AI integration: regulatory bodies and companies are increasingly using advanced data analytics and artificial intelligence to streamline regulatory processes, improve compliance, and predict potential issues. AI-driven tools are being used for everything from regulatory submissions to monitoring and reporting compliance. As I lead the head of regulatory operations forum that our company puts up, this has also been the key topic of discussion and on C-suite agenda.”
Megha Sinha
Managing Partner, Kamet Consulting Group
Megha is speaking at Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed Tests, a RAPS Convergence 2024 session on 19 September.
Connect and learn with the regulatory community at RAPS Convergence
The past few years have presented new challenges like the rise of AI at a time when regulatory professionals collaborate in person less often than before.
At RAPS Convergence 2024, we’ll gather to share knowledge and collaborate on solutions using the best resources we have — each other. This conference is where we can cut through the noise and confusion and learn face-to-face with experts and peers.
Don’t miss the biggest regulatory event of the year. Join us in Long Beach.