MULTIPLE THEMES

There are overarching themes that span the entire regulatory field. With so many disciplines, these valuable sessions provide key insights into multiple program tracks.

MONDAY, 11 SEPTEMBER
10:30 am-12:00 pm

Roundtable: What's New in Europe

The European regulatory landscape for medicines and medical devices is undergoing changes that need to be taken into account in the context of global regulatory strategies. Please join us for this interactive roundtable session to hear from representatives from European health authorities who will provide an update on key topics and discuss their impact on how medicines and medical devices will be regulated in the near future. Whether you have a global or a regional role, your input will be immensely valuable to understand in practice how these changes will affect your work.

Enrica Alteri, MD, head, Human Medicines Research and Development Support Division, EMA
João Duarte, associate director, Europe regulatory policy and intelligence, Takeda
Karl-Heinz Huemer, MD, PhD, Scientific Office, AGES, Austria
Walter Janssens, PhD, coordinator early phase development, FAMHP, Belgium
John Wilkinson, MBA, director of devices, Medicines and Healthcare products Regulatory Agency
Bettina Ziegele, MA, head, Innovation Office, Paul-Ehrlich-Institut


TUESDAY, 12 SEPTEMBER
8:30­­–10:00 am

Social Media Use in Regulated Industries

While social media began as a means of communication among individuals, there is now widespread use not only by institutions, but by media and even government agencies. Increasingly patients seek information not only on the internet but through multiple digital platforms. However, as a highly-regulated industry, pharma and biotech have unique challenges, leaving many to wonder how they can use digital platforms and remain compliant to FDA advertising and promotion rules. Join us to review how the industry is using social media today to promote products, services and brands. We’ll survey the tools evolving in social media, and teach you how to develop a sound social media compliance policy. Attendees will also be able to participate in a panel discussion of best practices and lessons learned.


Glenn Byrd, MBA, senior director, promotional regulatory affairs, Astrazeneca
Heidi Gertner, JD, partner, Hogan Lovells
Nicole Landreville, PEng, RAC, FRAPS, program manager, regulatory affairs, GE Healthcare
Margaret Mucha, MJ, CQA, RAC, FRAPS, senior leader RA and QA, IBM Watson
Nancy Parsons, counsel, Nancy M. Parsons Law
Mark Senak, JD, senior vice president and partner, FleishmanHillard
Alina Vargas, social media and communications specialist, Medtronic


10:30­­ am–12:00 pm                

Cybersecurity: Consideration for the Medical Device Industry

“Opportunity makes the thief” and with the internet opportunities are indefinite. Cybersecurity is the state of being protected against the criminal and unauthorized use of electronic data, or the measures taken to achieve this. What does cybersecurity mean to the medical device industry? What regulations are in place and how much affect does this have on the regulatory community? These are just some of the questions we will discuss in this session with FDA experts and major influencers in the industry. From the intrinsic safety of the embedded software and operation system in place to the end user in the hospital, the hospital network, the cloud and the internet itself, opportunity to protect our data are equally indefinite. Join us in understanding where we are in this space and how to safely move on to the next chapter. 

Bill Hagestad, senior principal cyber security engineer, R&D, Smiths Medical
Jos Kraus, PharmD, FRAPS, senior consultant medical technology, Academic Medical Centre of the University of Amsterdam
Matt Russo, senior director, product security, Medtronic
Suzanne Schwartz, MD, MBA, associate director for science and strategic partnerships, CDRH, FDA


4:00–5:30 pm

Recent Developments in Off-label Promotion

The area of off-label promotion has been heating up over the past few years with numerous court cases and new guidance issued by FDA. This session will focus on the developments over the past year in FDA guidance, new state laws, and updates in case law that have occurred in off-label promotion. This session will include a review of the recently issued FDA draft guidances and a memorandum offering its recommendations on appropriate medical product communications in different contexts, while also reminding industry that the agency will not remain silent if it objects to product messaging. We will also examine Arizona’s “The Free Speech in Medicine Act” allowing for off-label discussions. Plus, get an assessment on recent actions taken by FDA for off-label promotion and what we can learn from them.


Alan Minsk, partner, leader, food and drug practice team, Arnall Golden Gregory LLP

Margaret Mucha, MJ, CQA, RAC, FRAPS, senior leader RA and QA, IBM Watson
Elizabeth Mulkey, associate, food and drug law practice team, Arnall Golden Gregory LLP