We think you have liked this presentation. If you wish to download it, please recommend it to your friends in any social system. Share buttons are a little bit lower. Thank you!
Presentation is loading. Please wait.
Published byDiego Weaver
Modified over 5 years ago
© Hogan & Hartson LLP. All rights reserved. Pharmaceutical Compliance Forum Clinical Trials Case Study Stephen J. Immelt Thursday, November 8, 2007
© Hogan & Hartson LLP. All rights reserved. 2 FDA FDA as enforcer Form 483 process and expectations Timing False statement potential Warning letter potential Living with the record Broad regulatory powers beyond the particular trial
© Hogan & Hartson LLP. All rights reserved. 3 State Law Enforcement Highly unusual Could be promoted in connection with personal injury actions Subject to local considerations
© Hogan & Hartson LLP. All rights reserved. 4 OIG/DOJ Not classic false claims act situation, but can be motivated to find a hook Aggressive theories could focus on the approval process Numerous points of exposure for false statements Involvement of federal funding at investigator level Subject injury a material, aggravating factor
© Hogan & Hartson LLP. All rights reserved. 5 University Process Typical response for situations involving potential reputational harm No clear process or guidelines Participation or not? Risks Benefits? IRB issues
© Hogan & Hartson LLP. All rights reserved. 6 Congressional Action Intense interest in research related topics Process Privilege Working with staff Dealing with hearings
© Hogan & Hartson LLP. All rights reserved. 7 SEC/FCPA Growing interest in health care arena Heavy government presence in the delivery of health care in many countries creates broad potential exposure Importance of financial controls and oversight Heightened ambivalence about clinical research
© Hogan & Hartson LLP. All rights reserved. 8 Personal Injury Litigation Variety of exposures beyond direct injury Central importance of the study documents – not only consent but also investigator agreement and protocol Importance of rigorous oversight Access issues
© Hogan & Hartson LLP. All rights reserved. 9 Managing the Big Picture Importance of understanding the full range of issues Importance of regulatory process Importance of speed Impact of press scrutiny Dealing with what went wrong
© Hogan & Hartson LLP. All rights reserved. 10 Baltimore Beijing Berlin Boulder Brussels Caracas Colorado Springs Denver Geneva Hong Kong London Los Angeles Miami Moscow Munich New York Northern Virginia Paris Shanghai Tokyo Warsaw Washington, DC www.hhlaw.com For more information on Hogan & Hartson, please visit us at
© Hogan & Hartson LLP. All rights reserved. Second CIS Local Counsel Forum Park Inn Azerbaijan Hotel, Baku, Azerbaijan Tomasz Dobrowolski, Partner
© Hogan & Hartson LLP. All rights reserved. How We Get to Where We Want to Be – Managing GCP Inspections Pre-Approval Robert F. Church, Partner Hogan &
19 April 2012 The Office Agents Society Changes of Use from Commercial To Residential Michael Gallimore Hogan Lovells International LLP.
© 2009 Hogan & Hartson LLP. All rights reserved. Rebecca Armour April 2009 UK Rules on Corporate Expatriations Washington DC.
Art. 6 – 8 of the draft Unitary Patent Regulation Prof. Dr. Winfried Tilmann.
February 12, 2014 Life Sciences Enforcement Year in Review: Examining Hot Button Areas for FDA & Related Government Enforcement Peter Spivack, Hogan Lovells.
Legal Considerations When Doing Business in Australia Lisa Butler Admitted in Western Australia. Not Admitted in Texas. AACC Energy Conference 6 February.
Conflicts of Interest in Biomedical Research (A Brief History) PRIM&R Conference Boston, MA May 3, 2004 Barbara Mishkin Hogan & Hartson, L.L.P. 555 Thirteenth.
BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. What.
© Hogan & Hartson LLP. All rights reserved. NACD Capital Area Chapter Washington, DC September 9, 2008 Activist Hedge Funds in the Board Room: What Public.
Wireless Access Code: Download the agenda PDF at:
Subcommittee on Harmonization Mark Barnes David Forster.
16 July 2011 The Business Case for Mediation (for “ICC Arbitration & Amicable Dispute Resolution – Focus on India”) Jonathan Leach, partner, Hogan Lovells.
© Hogan & Hartson L.L.P. All rights reserved. JI and GIS: ERUs vs. Greened AAUs? A Legal Perspective Presentation at Project SKPI Workshop “Opportunities.
© 2013 Dechert LLP Defense Litigation Checklist September 26, 2013.
April 8, 2013 NPE litigation in Japan Activities and impact of FRAND commitments Eiichiro Kubota, Hogan Lovells Tokyo.
Understanding the GRAS Process Martin J. Hahn Hogan Lovells US LLP Date: July 16, 2013 Food and Agriculture Group.
January 2012 Workshop on competition law aspects International Legal Expert Meeting, January 2012 Leiden University, The Netherlands Jacques Derenne.
Recent developments in aviation liability & insurance: The 1973 Hague Convention on the law applicable to products liability: choice of law issues in aviation.
"The Role of Arbitration in the Dispensal of Justice" Does Arbitration Maintain the Advantages it Traditionally Enjoyed? Nathan Searle, Senior Associate.
© 2019 SlidePlayer.com Inc. All rights reserved.