Contact
Tracy Erickson
Gardner Law, PLLC
651-430-7150
terickson@gardner.law
Learn about new laws and regulations from European and US regulatory lawyers.
Topics include: MDR, Transparency, GDPR, Compliance and more.
Agenda:
8:00 a.m. – 8:30 a.m.
Registration – Breakfast provided.
8:30 a.m. – 9:30 a.m.
General Data Protection Regulation (GDPR).
Topics include: controller/processor concept, subject access requests, data breaches, international data transfers, clinical trials, enforcement trends.
9:30 a.m. – 10:15 a.m.
EU Medical Device Regulation (MDR).
Topics include: New obligations, responsible person(s), notified body concerns, MDD vs. MDR.
10:15 a.m. – 10:30 a.m.
Break
10:30 a.m. – 11:00 a.m.
EU Health Care Compliance.
Topics include: MedTech Europe Code of Ethical Business Practice, health care compliance in the EU and Germany, transparency.
11:00 a.m. – 12:00 p.m.
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., President, Gardner Law and
12:00 p.m. – 1:00 p.m.
Panel Discussion – Lunch provided.
Speakers from the morning convene for a moderated panel discussion with audience participation. Come equipped with your questions.
Moderated by Heather Potter, J.D., Associate Attorney, Gardner Law