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RAPS 2014 Austin

September 24, 2014

RAPS 2014 is in Austin next week, and I’m excited for the event. There’s a good slate of sessions and, given the venue, lots of opportunities for networking with colleagues. Although it’s hard to predict what the most valuable session will be beforehand, I wanted to share some of the sessions I’m looking forward to.

Enhancing Regulatory Efficiency Through Good Review Practices (GRevPs) and Good Submission Practices (GSP)

Monday 1:30–3:00 pm

  • Mike Ward, manager, international programs division, Bureau of Policy, Science and International Programs, Therapeutic Products directorate, Health Canada
  • Marilena Bassi, director, Office of Planning, Performance and Review Services, Therapeutic Products Directorate, Health Canada
  • Deborah Jansen, center quality manager, CBER, FDA
  • Li-Ling Liu, director, Division of Medicinal Products, Food and Drug Administration, Ministry of Health and Welfare, Taiwan
  • Toshihiko Tsunenari, Japan Pharmaceutical Manufacturers Association

Communicating Actionable Regulatory Intelligence

Monday 1:30–3:00 pm

  • Kimberly Belsky, executive director policy, labeling, and adpromo, regulatory affairs, Valeant Pharmaceuticals
  • João Duarte, regulatory intelligence and policy manager, H. Lundbeck A/S
  • Alexander Gaffney, RAC, manager, regulatory intelligence, Regulatory Affairs Professionals Society (RAPS)
  • Alan Minsk, JD, partner, Arnall Golden Gregory LLP

Medical Devices in Latin America

Monday 3:30–5:00 pm

  • Seth Goldenberg, PhD, senior principal scientist, NAMSA
  • Anne Blanchard, CEO and clinical operations manager, Blanchard & Asociados
  • Marisa Carcione, regulatory manager, IPRAT
  • Luciano Ferreira, RAC (Global), regulatory intelligence manager – Latin America, GE Healthcare
  • Lílian Garcia Orofino, senior regulatory and government affairs manager – Latin America, Boston Scientific

AdPromo: Implications of US/Global Noncompliance on Your Company, Processes and People

Monday 3:30–5:00 pm

  • Kimberly Belsky, executive director policy, labeling, and adpromo, regulatory affairs, Valeant Pharmaceuticals
  • Philomena McArthur, senior director, regulatory and health care compliance, Johnson & Johnson PRD LLC
  • Alan Minsk, JD, partner, Arnall Golden Gregory LLP

Regulatory as a Strategic Partner Within the Business

Monday 3:30–5:00 pm

  • Kathleen Wessberg, director regulatory affairs, regulatory operations, established pharmaceuticals division, Abbott
  • Liam C. Feely, PhD, vice president, manufacturing science & technology, AbbVie
  • Virginia Giddings, director strategic R&D, Abbott Nutrition
  • Ben Verwer, vice president strategic initiatives, BD Diagnostics

Impact of the New Proposed Regulations on Clinical Data Requirements in Europe

Tuesday, 8:30–10:00 am

  • Bassil Akra, PhD, director clinical affairs, TÜV SÜD Product Service GmbH
  • David Rutledge, PharmD, FCCP, FAHA, director, clinical research, Abbott
  • SengDao VanMany, senior clinical research scientist, global clinical operations, Hollister Incorporated
  • Daniel Whitter, clinical project leader, NAMSA Medvance

3D Printing: Crossing the Boundaries of Regulatory

Tuesday, 11:00 am–12:30 pm

  • Laura Bosworth-Bucher, CEO and co-founder, TeVido BioDevices
  • Jim Rosa, vice president, QA/QE consulting, Dohmen Life Science Services

Understanding the Challenges of Bringing a Mobile Medical App to the Market

Tuesday, 11:00 am–12:30 pm

  • Michael Swit, JD, special counsel, FDA law practice, Duane Morris LLP
  • Daniel Olivier, president, Certified Compliance Solutions Inc.
  • R. William Soller, PhD, principal, and faculty, University of California San Francisco

Implementing Social Media in a Regulated Landscape

Tuesday, 1:30–3:00 pm

  • Ilze Kurins Antons, senior director, US regulatory affairs, Lundbeck
  • Matthew Boyd, director digital and social media, global commercial excellence. EMD Serono Inc.
  • Suzanne (Sue) Niedrich, director, digital marketing, digital center of excellence, neurology, Lundbeck LLC
  • Stella Stergiopoulos, project manager, Tufts Center for the Study of Drug Development

Bringing Novel Devices to Market

Tuesday, 1:30–3:00 pm

  • Seth Goldenberg, PhD, senior principal scientist, NAMSA
  • Jennifer Bolton, manager, regulatory affairs, vascular surgery, Boston Scientific Corporation
  • Chris Mullin, MS, director, regulatory, biological safety, strategic consulting services, NAMSA
  • Ronald Rakos, MEng, PhD, MBA, team leader vascular, BSI Americas
  • Nicole Wolanski, Capt, USPHS, director, PMA Program, Program Operations Staff, ODE, CDRH, FDA

Ok, so much for my take on RAPS 2014–what about you all out there? What sessions are you planning to attend? What are you most looking forward to next week?

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