2020 Regulatory Update from Both Sides of the Pond

December 03, 2020

Complimentary 4-part webinar series tailored to pharmaceutical and medtech companies.

Topics:

  • Privacy
  • Regulatory
  • Health Care Compliance
  • Due Diligence for Buyers and Sellers

Attendees include legal, compliance, regulatory, quality, and privacy professionals.

CLE credits - Application pending in various jurisdictions

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


Webinar 1: Privacy Update

Topics:

CCPA, HIPAA, GDPR, Clinical trial privacy. Case studies.

Speakers:

  • Heather Potter, J.D.,CIPP/E, Associate Attorney, Gardner Law
  • Oliver Süme, Partner, Technology, Outsourcing and Privacy, Fieldfisher

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Webinar 2: Regulatory Update

Topics:

FDA Emergency Use Authorization (EUA) and MDR. Case studies.

Speakers:

Download EUA Presentation

Download MDR Presentation

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Webinar 3: Health Care Compliance Update

Topics:

Virtual detailing, recent fraud & abuse case review, Sunshine (transparency) updates.

Speakers:

Download US Presentation

Download EU Presentation

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Webinar 4: Regulatory Compliance Due Diligence - U.S. and Germany

Topics:

Performing and preparing for US health care compliance diligence. How to design and implement an effective US health care compliance program. Typical due diligence questions/topics and deal structures. How to structure, negotiate and implement the acquisition of German health care companies. Typical German due diligence questions, topics and deal structures. Case studies.

Speakers:

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