Day 2


11:00 AM 

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

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11:05 AM– 12:05 PM 

Biologics and Biosimilars
Christopher Gallo
, Associate, Axinn, Veltrop & Harkrider LLP

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12:05 – 1:05 PM 

Regulation of Over-the-Counter (OTC) Drugs
Deborah L. Livornese, Director, Hyman, Phelps & McNamara, PC

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1:05 – 1:15 PM


1:15 – 2:15 PM

Regulation of Drug Manufacturing
Peter V. Lindsay, Partner, Paul Hastings

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2:30 – 3:30 PM

Regulation of Drug Marketing
Heather Banuelos
, Counsel, King & Spalding LLP
Gillian M. Russell
, Counsel, King & Spalding LLP

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3:30 – 3:45 PM


3:45 – 5:00 PM

Violations and Enforcement
Tiffany Humphries, Senior Associate, BakerMcKenzie

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An access link will be provided to attendees via email upon registration.

If you are registering on behalf of someone else, the link to access the webinar will go to the email address provided at the point of registration.

Those registering on the day of the webinar will receive an access link via email upon successful payment.


We use Zoom to conduct webinars which works on most devices. You may participate in the webinar on a mobile device via the Zoom App or by dialing in. If you require the dial in information, please contact Maura Schatz at [email protected].

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Webinar recordings are sent via email as soon as we are able to process and verify the quality of the recording. This usually occurs within 3 business days of a webinar broadcast.

If multiple people at your organization wish to participate from separate devices, each will be required to purchase access.