Card image cap

Keeping Up with FDA and DOH Regulations

Level: Advanced
Runtime: 60 minutes
Recorded Date: September 25, 2019
Click here to share this program
Download PDF
Closed Caption


  • 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


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

General Counsel Conference
Card image cap


Card image cap

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.

Card image cap

Shawn Gibbs

Associate General Counsel

Shawn Gibbs is the Associate General Counsel at Seqirus.

Card image cap

Similar Courses

Card image cap
64 minutes
"I Am Not a Cat" Proceedings in a Virtual World
Besides becoming a pop-culture catchphrase, how has the shift to a virtual environment impacted proceedings over the last year, and what changes do you believe are here to stay? Our panel of experts will examine some of the greatest challenges, faux pas, and successes in virtual proceedings over the course of this transformative time.

Women, Influence & Power in Law Conference


Add to Cart
Card image cap
63 minutes
2021: The Year of the ELM
Panelists will clarify what constitutes an ELM platform, examine its unique and compelling capabilities, and discuss its strategic and tactical advantages, particularly those stemming from data-driven insights and machine-driven decision making. Attendees will gain a clear understanding of the significance of the emergence of ELM solutions, what firms and law departments can achieve with ELM platform, and practical and ethical considerations related to adopting an ELM solution.



Add to Cart
Card image cap
97 minutes
26 Words that Created the Internet - Basics of the Communications Decency Act Section 230 Safe Harbor
This program will examine the basics of CDA 230 and its day to day affect for those who advise internet businesses as well as those who litigate against them. It will give practical guidance as to what extend internet companies can or should edit or censor the information their users contribute to their sites and to what extent those users will actually be liable.

New Media Rights


Add to Cart
Card image cap
76 minutes
360-Degree of Investigation - A Roundtable Discussion Regarding Investigations of Debtors and Recovery of Assets
This panel of lawyers and insolvency professionals with bankruptcy expertise will lead a roundtable discussion regarding investigation of debtors and recovering assets to enhance the value of a bankruptcy estate.

American Bankruptcy Institute


Add to Cart
Previous Next