With RAPS’ Regulatory Convergence now less than six weeks away, it’s a good time to take a look at the conference agenda and start planning. We selected 10 sessions—aside from the plenaries—that we think are likely to be popular this year, based on current hot topics or popular areas within regulatory affairs. Last week, in part one of this two-part series, we highlighted the first five. In part two below, we take a look at five more.
Bear in mind this list is by no means complete. Of the more than 100 individual sessions, featuring more than 250 speakers, there are many that will be highly informative and well worth attending. Your needs and interests are highly individual, and I recommend you have a look at the full agenda to learn more about all the Convergence sessions. Also note the sessions highlighted here are presented in no particular order.
6. EU Medical Device Regulation and In Vitro Diagnostic Regulations
Several months ago when the EU reached an agreement on updates to its regulations governing medical devices and in vitro diagnostics, it was the culmination of years of negotiation. The Medical Device Directives had not been updated since the 1990s. The new rules could be adopted by the end of this year and would go into effect three years later for devices and five years later for IVDs. This session, Monday, 19 September, 4:00–5:30 pm, will examine implementation of the new rules and best practices for regulated companies. Confirmed speakers include a representative from the Dutch Ministry of Health, Welfare and Sport.
7. Zika and Clinical Trials in Latin America
The outbreak of the Zika virus has undoubtedly been one of the most tragic news stories of the year so far. With its severe effects on newborn babies and the lack of a vaccine or any effective treatments, the World Health Organization has declared it a global public health emergency. Latin America has seen the most reported cases. This session, Tuesday, 20 September, 3:30–4:45 pm, will specifically focus on Puerto Rico and the latest initiatives in clinical research for the development of new diagnostics and treatments as well as regulatory access for pandemic/emergencies throughout the Americas.
8. CDRH Strategic Update: Initiatives/Priorities
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has established several priority areas it will pursue over the next few years, including the creation of a national device evaluation system, engaging patients in the regulatory process and strengthening its organizational culture. In this session, Monday, 19 September, 10:00–11:15 am, CDRH Director Jeff Shuren, MD, JD, will present an update on the center’s progress and future plans via video conference.
9. Real-World Evidence: Registry, Observational and Clinical Studies
Calls to use more real-world evidence to inform regulatory decisions have been gaining steam. New FDA Commissioner Robert Califf has called it a "top programmatic priority" for the agency, and FDA has proposed increasing its use of real-world evidence as part of the reauthorization of the Medical Device User Fee Act. A bipartisan think tank recently released a report outlining what it sees as opportunities for FDA to modernize the drug approval process using real-world evidence. This session, Tuesday, 20 September, 1:00–2:30 pm, will examine several ways of gathering real-world evidence, as well as the strengths and weaknesses of each one.
10. The Changing Landscape of Off-Label Promotion
Earlier this year, FDA and Amarin reached a settlement that allows the drugmaker to use truthful information about unapproved uses for its prescription fish oil pill in marketing materials. The court case and several others revolving around off-label promotion have caused some controversy, but how much they ultimately will impact drug and device promotion remains unclear. This session, Monday, 19 September, 1:30–3:00 pm, will examine lessons learned from these cases as well as their implications for future marketing efforts.
For more information or to register for the 2016 Regulatory Convergence, visit RAPS.org/Convergence.
10 Can't Miss Regulatory Convergence Sessions: 1-5