Arnold & Porter is hosting a full-day, interactive program aimed at providing industry professionals with unique real world enforcement perspectives and best practices to prepare for and respond to FDA and European inspections and enforcement actions.
The program will take place at The Grand Summit Hotel, 570 Springfield Avenue, Summit, NJ 07901 on Thursday, April 30, 2015. There is no cost for participating.
Click here to RSVP.
Learn effective risk avoidance and management strategies from experienced regulatory and litigation lawyers, a former Assistant United States Attorney, a former FDA Associate Chief Counsel for Enforcement, a former senior official of the UK Regulatory Authority, and other attorneys with decades of experience in drug and medical device enforcement matters.
This boot camp will provide an overview of the authorities, theories, and trends in regulatory enforcement actions and walk a hypothetical company and product through an FDA inspection and enforcement action, and a European pharmacovigilance enforcement scenario.
- Understanding the scope of FDA and EU enforcement authorities
- Evaluating corporate and executive exposure in the US and EU
- Agency processes for enforcement decision making
- Best practices in handling inspection observations and letters
- Negotiating consent agreements and other settlement mechanisms
- Challenging regulatory authorities in court
- Anticipating and mitigating collateral consequences of regulatory enforcement
Arnold & Porter Speakers Featured at the Event:
Daniel Kracov, Partner and FDA/Healthcare Practice Co-Chair, Washington, DC
Ian Dodds-Smith, EU Life Sciences Partner and FDA/Healthcare Practice Co-Chair, London
Vernessa Pollard, FDA/Healthcare Partner, Washington, DC, Former Associate Chief Counsel for Enforcement, OCC, FDA
Lincoln Tsang, EU Life Sciences Partner, London, Former head of biologics of UK Regulatory Authority, Former Board Member, NIBSC, Former Advisor to EMA and European Commission
Adela Williams, EU Life Sciences Partner, London
Alison Brown, EU Life Sciences Partner, London
Daniel Pariser, Product Liability Partner, Washington, DC
Philip Desjardins, FDA/Healthcare Counsel, Washington, DC, Former Regulatory Counsel and Associate Center Director for Policy, CDRH, FDA
Marilyn May, FDA/Healthcare Counsel, Washington, DC, Former head of healthcare fraud enforcement for the United States Attorney's Office in the Eastern District of Pennsylvania