16 reasons we’re excited for RAPS Convergence 2024
RAPS Convergence 2024 is right around the corner, as the regulatory community gets ready to assemble in Long Beach for three days of connection, education and celebration.
We asked a few of our RAPS Convergence 2024 presenters what they’re most excited for at this conference. Here’s what they said.
“We are excited about presenting on how to navigate the changing world of LDTs, drawing upon our experience with the latest transition in the industry (MDR/IVDR), we hope that attendees can take a pragmatic and risk-based approach to this transition while being cost-effective.”
Megha Sinha
Managing Partner and CEO, 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.
“I look forward to showcasing the innovative work Philips is doing in regulatory affairs across our portfolio from diagnosis and minimally invasive treatment in the hospital to monitoring and after care at home.”
Lee Evans
Head of Global Regulatory Affairs, Philips
Lee is speaking at Manufacturer's Approach to Advancing Health Equity for Medical Devices, a RAPS Convergence 2024 session on 19 September.
“I look forward to my first Convergence since joining the MedTech industry from the US Food and Drug Administration. I plan to network with regulatory affairs colleagues and continue my lifelong learning journey.”
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.
“I'm looking forward to seeing old friends and making new ones! I know that many of my former FDA colleagues will be attending, and it will be great to catch up on what's new at the Agency.”
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.
“Networking, business development.”
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’m looking forward to the upcoming Convergence in Long Beach, California, where we will unite with RA colleagues from across the globe to exchange knowledge and experiences in this dynamic profession.”
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.
“Looking forward to meeting and exchanging ideas with subject matter experts about positive and negative experience in implementation of various requirements.”
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.
“I am excited to engage in discussions on enhancing entry-level opportunities in regulatory affairs, share insights on our panel, and network with industry leaders. The conference offers a unique platform to explore the latest trends, technologies, and best practices in the field, fostering professional growth and collaboration.”
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.
“I am looking forward to learning about the latest in new regulatory guidance and any lessons learned from the brave few who have already pursued the new opportunities afforded by these guidances.”
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.
“Networking with other regulatory professionals and learning about new and emerging trends in regulatory affairs.”
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.
"'Regulatory affairs' isn’t a single career. People come in with a diversity of backgrounds, and their career paths reflect that diversity. RA professionals may be STEM experts, legal experts, marketing experts, submissions experts, or management experts. I’m looking forward to Convergence, where all of these different types of professionals who make up 'regulatory affairs' come together and can learn from each other."
Jay Vaishnav
Director, Regulatory Affairs, Canon Medical Informatics
Jay is presenting at Finding a Job in Regulatory Affairs or Regulatory Compliance: Skills for Success, a RAPS Convergence 2024 session on 19 September.
“I'm excited to dive into the ever-changing world of regulations at RAPS Convergence! Hearing directly from experts about the latest updates for medical devices, pharmaceuticals, and beyond will be invaluable. But that's not all – I'm also eager to learn how new technologies are streamlining the entire process. Imagine the efficiency boost! And of course, reconnecting with colleagues and making new connections in the regulatory field is always a highlight. Can't wait to be there!”
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.
“We are in a time of unprecedented regulatory innovation — I am looking forward to collaborating with my colleagues to synthesize the latest advances in real-time.”
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.
“This year I am looking for updates related to the European and US regulations related to medical devices, as well as understanding the tendencies and upcoming requirements for this sector. Also, I am looking to improve my network and share information about regulatory affairs environment in Brazil.”
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.
“For me, RAPS Convergence is an excellent opportunity to connect and grow with peers to discuss challenges and ideas around regulatory affairs. The regulatory profession is exciting because it's constantly evolving and there is always more to learn, and attending RAPS is a great way to stay on top of evolving regulatory trends and challenges.”
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.
“RAPS Convergence 2024 will present a unique opportunity for my professional growth by allowing me the chance to network and learn from industry experts and peers. The great thing about regulatory affairs is it's constantly evolving, so there is always room to learn, grow, and make a difference.”
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.
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.