Program Registration

12:30 - 12:45 PM

Program Introduction

Speaker: Mark Webber

 12:45 – 1:15 PM

Session one: FDA Violations and the Park Doctrine Threat 

• Discuss application of Park Doctrine (strict and vicarious liability) to responsible corporate officers at drug and device companies resulting from FDA violations
• Discuss the recent call for the reinvigoration of Park Doctrine enforcement
• Cover recent FDA adulteration and misbranding cases (Alere, St. Jude, Avanos Medical)

Speaker: Amanda Johnston

1:15 – 1:45 PM

Session two: EU Healthcare Compliance Update

• Update EU Life Sciences Key Markets
• The Sun now also Shines in Italy (New Transparency Law)
• Direct Sponsoring in The Netherlands
• A new Medical Device Charta in France

Speaker: Cord Willhöeft

1:45 – 2:15 PM

Session three: Pre-Approval Communications and Trial Recruitment Do’s and Don’t’s

• Rules for communicating (not promoting) before FDA approval
• Scientific exchange and how it can be used lawfully
• How to recruit patients lawfully after the Covid slow down

Speaker: Mark Gardner

2:15-2:30 PM – Break

2:30 – 3:00 PM

Session four: International Data Transfers: How can international businesses ensure compliance?

• An overview on how to navigate international businesses through the compliance jungle of international data transfers under the GDPR
• The use of the new modules for Standard Contractual Clauses
• Upcoming EU-US Trans-Atlantic Data Privacy Framework

Speaker: Oliver Süme

3:00 – 3:30 PM

Session five: Cybersecurity

• FDA cybersecurity guidance
• US privacy update

Speaker: Paul Rothermel

3:30 – 4:00 PM

Session six: EU MDR update and UK/Swiss Market Entry 

• Update on the EU MDR Implementation by Manufacturers located in the US
• Placing medical devices on the UK and Swiss markets – current requirements

Speaker: Cord Willhöeft

4:00-4:30 PM

Session seven: Panel Discussion 

• Q&A with general counsel from industry on various regulatory topics

Panelists:

• Mike Pisetsky, General Counsel and Chief Administrative Officer, SI-Bone
• William Revelos, Vice President and General Counsel, CorVista Health
• Alaleh Azarkhish Nouri EVP, Chief Legal Officer & Corporate Secretary at PROCEPT BioRobotics

Moderator: Amanda Johnston

Register Here

Attendees include in-house general counsel, corporate attorneys, compliance officers, regulatory lawyers, executives, and allied non-lawyer professionals that work in the medical technology, pharmaceutical, biotechnology, and diagnostics industries.

CLE credits – Applied for in Minnesota and self report in other states.

Please contact Tracy Erickson at terickson@gardner.law with questions.