Topic:  RAPS ROUNDUP_Highlights from the Annual Convergence

Confirmed Panelists: Stefan Burde, Sathya Ganesan, Sheila Plant, Tyler Vandivort 

The Annual RAPS Convergence is the biggest conference for regulatory affairs professionals and draws international speakers from industry, non-profit organizations, FDA, and international regulatory authorities. Can’t go this year?  Sorry to hear that, but we have your back!

A panel of attendees will provide quickfire insights into the most interesting topics and sessions from this year’s RAPS Convergence. They intend to bring you to the Convergence, post event, so you can also get a feel of what has been rumbling in the regulatory community this year. The speakers will address some highlights and any surprises. They certainly can’t cover every session from the Convergence and will need to cherry pick the topics to talk about, but we will also take your questions. Join us for an evening of networking/food, and an immersion into RAPS Convergence’s most talked about topics!

Confirmed Panelists

Stefan Burde, PhD is the founder and principal consultant of IVDR Solutions, a regulatory consultancy focused exclusively on helping IVD manufacturers master the CE-marking process. Stefan holds a PhD in Pathology from the University of Rochester, and has over 13 years of experience in the in vitro diagnostic industry and over 10 years of Notified Body experience as an auditor, technical documentation reviewer, and strategic director.  He has spoken extensively at international conferences on topics related to IVDR implementation and compliance.

 Sathya Ganesan, PhD, RAC is a biopharma researcher with over 20 years of experience in oncology, bone health, and neurology. She received her PhD from the University of Rochester and moved to North Carolina for academic research at Duke University in Cancer Biology and Pharmacology. She started her regulatory career in 2014 after a US RAC certification and has worked at a CRO as well as small and large sponsor companies progressively building her strategic expertise. She is currently employed as US Regulatory Science lead for programs in neurology and oncology at UCB. Sathya has actively engaged in mentorship and support for career development through organizations such as Women in Bio, NCRAF and Health Care Businesswomen’s Association.

Sheila Plant, PhD, MHS, RAC is Vice President of Regulatory Affairs at Allucent. In this role, Dr. Plant is responsible for regulatory and clinical strategy and support for client’s innovative medical products. She has greater than 26 years of experience in biomedical science including 17+ years in regulatory affairs and clinical research. Sheila has extensive experience working with sponsors to author, compile, and submit initial INDs, IND amendments, NDAs, and NDA amendments. She has led marketing application projects leading to FDA approval for drug and drug-device combination products. Sheila received her PhD in Neurobiology from UNC-Chapel Hill and her Master’s in Health Science from the Duke University School of Medicine. She has been RAC certified since 2011.

 Tyler Vandivort is a board-certified toxicologist and regulatory affairs professional. He currently serves as a Regulatory Lead at UCB Biopharma where he focuses on the development of novel biologics for rare and/or autoinflammatory diseases. He has also held various roles in the start-up and CRO spaces, including as a GLP immunotoxicologist, and as a nonclinical regulatory consultant. Tyler holds elected roles on both the American College of Toxicology's Outreach Committee and the Regulatory Affairs Professionals Society's Convergence Planning Committee and has contributed to various articles, chapters, conference sessions, and workshops in both fields. He is also an active mentor with several organizations, including City Tutors NYC, and the Pathway for Patient Health micro-credential program in Quality. Tyler joined the University of Cincinnati's Masters of Science in Drug Development program as an Adjunct Assistant Professor in 2023.

EVENT LOGISTICS:

For in-person attendees, there is a networking reception from 5:30-6:30. 
The hybrid seminar presentation will be held from 6:30-8, including an open floor for audience questions. 

Thank you to ALLUCENT for generously providing the event space to support this educational forum! **PLEASE NOTE NEW LOCATION!!**

Register for this event below. The event is free for all NCRAF members (standard as well as student/post-doc/unemployed jobseeker); for non-members, registration is $20.

REGISTER for 2026-10-22 RAPS Roundup

Annual membership in NCRAF is currently $50 for standard membership; a reduced annual membership rate ($15) is available for students/post-docs/unemployed job-seekers.

Become an NCRAF member