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Keeping Up with FDA and DOH Regulations


Level: Advanced
Runtime: 60 minutes
Recorded Date: September 25, 2019
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Agenda


  • Guidance Documents
  • Medical Device Development Tools (MDDT)
  • Digital Health Initiative
  • 21st Century Cures
  • Smart Regulation Principles for Digital Health Tech
Runtime: 1 hour
Recorded: September 25, 2019

Description

Pharmaceutical and biotechnology companies are heavily regulated to ensure compliance with federal safety laws for use and consumption. The US FDA oversees regulatory activity across the globe, forcing pharma & life sciences companies to identify quality issues before they impact the production. The FDA also has the authority to inspect manufacturers and facilities that are registered, including compound pharmacies, to ensure compliance with safety ordinances. Additionally, life science corporations must also comply with state-regulated laws implemented by each respective state’s DOH. So with all of these laws and regulations in effect, how does one ensure compliance across the board?

This panel will explore what GCs need to know to effectively advise their organizations on operations standards and compliance risks.

This program was recorded as part of ALM & Corporate Counsel's Annual General Counsel Conference on September 25th, 2019.

Provided By

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Panelists

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Gina Mazzariello

Vice President
Boehringer Ingelheim Pharmaceuticals, Inc.

Gina Mazzariello is the Vice President of US Human Pharma Business Law at Boehringer Ingelheim Pharmaceuticals, Inc.

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Shawn Gibbs

Associate General Counsel
Seqirus

Shawn Gibbs is the Associate General Counsel at Seqirus.


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