Regulatory update from both sides of the pond

November 18, 2019

In November 2019, we held programs on MDR, GDPR, US/EU health care compliance, and social media.

See below to get the slides and hear about our event!

General Data Protection Regulation (GDPR)

Topics include: controller/processor concept, subject access requests, data breaches, international data transfers, clinical trials, enforcement trends.

Speaker: Oliver Süme, Partner, Technology, Outsourcing and Privacy, Fieldfisher

Download GDPR Presentation

EU Medical Device Regulation (MDR)

Topics include: New obligations, responsible person(s), notified body concerns, MDD vs. MDR.

Speakers: Dr. Cord Willhöft, LL.M., Partner, Life Sciences, Fieldfisher and
Jim Murray, M.Sc., Consultant, Gardner Law Download MDR Presentation Download Quality Presentation

EU Health Care Compliance

Topics include: MedTech Europe Code of Ethical Business Practice, health care compliance in the EU and Germany, transparency.

Speaker: Dr. Cord Willhöft, LL.M., Partner, Life Sciences, Fieldfisher

Download EU Healthcare Compliance Presentation

US Health Care Compliance

Topics include: 2020 AdvaMed revisions, transparency reporting changes, compliance program auditing and monitoring, recent cases.

Speakers: Mark Gardner, M.B.A., J.D., Managing Attorney, Gardner Law and
Amanda Johnston, J.D., R.A.C. Sr. Attorney, Gardner Law Download U.S. Healthcare Compliance Presentation

← October 2019: How to avoid “going viral” with the FDA January 2020: Did you miss these important 2019 FDA medical device guidance documents? →