IN VITRO DIAGNOSTICS

Expand your scope and knowledge of the in vitro diagnostics field. Our sessions will explore global trends in both emerging and developed markets, agency guidance changes and other topics that impact the regulatory professional throughout the product lifecycle including clinical, quality and compliance.

TUESDAY, 12 SEPTEMBER
8:30­­–10:00 am

EU IVDR: Classifications/Performance Evaluation

The new IVD regulations in Europe, the counterpart to the medical device regulations, will see a vast increase in the number of manufacturers needing a Notified Body. This session will include strategies and expectations from both industry and Notified Body on how to deal with the legacy products situations.

Stefan Burde, PhD, IVD product expert, BSI
Connie Del Buono, founder, director regulatory and compliance, Synoptyx Inc.
Ian Purdy, PhD, senior vice president quality and regulatory affairs, Haemonetics
Sue Spencer, head of global medicine device services, UL


10:30 am–12:00 pm

IVDs in China: Navigation of Type Testing and Clinical Evidence Expectations

As the Chinese regulations evolve around both Devices and Diagnostics, the pathway becomes less clear for those in the international market. This session aims to bring local experts directly from China and the Asia Pacific to provide first-hand experience in gaining approvals for IVDs in China. The presentation will include the testing requirements, what’s expected of a clinical trial, clinical evidence and most importantly, how to get the product approved.


Grant Bennett, CEO and senior consultant, Brandwood Biomedical
Arthur Brandwood, PhD, FRAPS, founder and principal consultant, Brandwood Biomedical
Carole Ledford, international regulatory affairs manager, BD


1:15–2:45 pm

Current State: In Vitro Diagnostic Device Studies Using Leftover Human Specimens

The use of collected human specimens is essential to biomedical research and the development of new in vitro diagnostics. Join our discussion for an update on the requirements for informed consent for use of specimens in FDA-regulated IVD studies. Plus, after rounds of negotiation and revision, we’ll discuss the industry impact of the impending regulatory requirements for EU IVDR. 

Connie Del Buono, founder, director regulatory and compliance, Synoptyx Inc.
Chitra Edwin, PhD, RAC, senior vice president of regulatory affairs and compliance, Spotlight Innovation Inc.
Erik Vollebregt, LLM, partner, Axon Lawyers

4:00–5:30 pm

US Regulatory Landscape for Laboratory Developed Tests (LDTs)

Do you wonder what is happening with the regulation of Laboratory Developed Tests in the US since the FDA draft guidances were published in 2014, a public workshop was held in 2015 and a discussion paper was issued in early 2017? Diagnostic industry and clinical laboratory experts will share their insight on the current status of this area and future prospects for how the regulatory landscape is taking shape.

Shirley Furesz, PhD, RAC (Canada), associate director, medical devices, Mapi Group
Mark DuVal, JD, FRAPS president, DuVal & Associates PA 
Steven Gutman, MD, MBA, strategic advisor, Myraqa, Illumina, Inc.
Thomas Sparkman, vice president, government relations, ACLA