Topic:  RAPS ROUNDUP_Highlights from the Annual Convergence

Confirmed Panelists: Kirsten Messmer (KM Intel LLC) and Sheila Plant (Allucent)

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

Kirsten Messmer, PhD, RAC is the owner of KM Intel LLC which supports companies with actionable intelligence to inform their policy and regulatory strategy. She was previously a Senior Research Analyst and contributed to the research for AgencyIQ on regulatory issues affecting the bio-/pharmaceutical industry in the US and Europe. Before that, Kirsten was a Principal Regulatory Affairs Specialist at PPD providing global regulatory intelligence to support efficient, compliant and successful clinical research and drug development for biopharmaceuticals and advanced therapies. Kirsten has held additional positions in university and biotechnology research and has 14+ years' experience in regulatory affairs with a particular focus on regulatory intelligence. Kirsten received her PhD in Neuroscience from the University of Sheffield (Sheffield, UK), a Biology Diploma from the Eberhard-Karls University (Tübingen, Germany) and holds a Regulatory Affairs Certification (RAC) in US regulation.

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.

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.

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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.

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