Regulatory update from both sides of the pond
November 18, 2019In 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!
Watch Regulatory Event Recording
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
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
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Past Alerts
November 2020: OIG issues Special Fraud Alert on Speaker Programs
November 23, 2020
September 2020: FDA resumes domestic inspections. Are you ready?
September 29, 2020
August 2020: GDPR update: Why did a European court recently invalidate the EU-US Privacy Shield?
August 25, 2020
July 2020: Are you promoting products virtually in the COVID era?
July 30, 2020
