Internal Investigations for the Pharmaceutical & Medical Device Industries

Thursday, April 27, 2006

About

Learn the Art of Conducting an Effective and Thorough Internal Investigation

The art of conducting an effective internal investigation is now a critical competency for drug and device makers. Recommendations under the Federal Sentencing Guidelines and OIG Guidance - and the PhRMA and AdvaMed Codes for routine audits, hotline call centers, and whistleblower protections have acted as a catalyst for the development of corporate guidelines for internal investigations. Most drug and device makers have adopted certain protocols for the conduct of internal investigations. However, the true test for the effectiveness of such protocols only occurs in such instances as when a discrepancy is identified in an audit or when a hotline call is placed. You need to ensure your client has the capability to discover the truth of the matter and determine whether prohibited conduct has occurred. You must be able to identify the problem, preserve the company's rights, and institute appropriate remedial measures - before the government investigators appear at the doorstep. And, even more importantly, when the government investigators do come knocking, you must have procedures in place that will guarantee a seamless and appropriate response.

This American Conference Institute publication on Internal Investigations for the Pharmaceutical and Medical Device Industries will provide you with a step-by-step guide for every phase of an internal investigation, tailored to the unique concerns of the drug and device industries. An outstanding faculty of leading in-house counsel and expert attorneys many of whom are former government prosecutors will lead you through the intricacies of the investigatory process and provide insights on:
  • How recent trends in government investigations of drug and device makers can help identify new areas of concern and shape the course of internal investigations
  • How to determine whether a reported matter truly is a referable compliance incident
  • How to negotiate a thorough confidentiality agreement when the waiver of attorney-client and/or work-product privilege cannot be avoided employees about self-incrimination in the interview process
  • Under which circumstances are you obligated to call the government?
  • What protocols should be established for when a government investigation commences, and how can such protocols be incorporated into existing compliance programs
  • When it's necessary to try to identify a whistleblower
  • How to develop corrective action plans that work and how to negotiate a CIA that you can live with

Contents & Contributors

About

Learn the Art of Conducting an Effective and Thorough Internal Investigation

The art of conducting an effective internal investigation is now a critical competency for drug and device makers. Recommendations under the Federal Sentencing Guidelines and OIG Guidance - and the PhRMA and AdvaMed Codes for routine audits, hotline call centers, and whistleblower protections have acted as a catalyst for the development of corporate guidelines for internal investigations. Most drug and device makers have adopted certain protocols for the conduct of internal investigations. However, the true test for the effectiveness of such protocols only occurs in such instances as when a discrepancy is identified in an audit or when a hotline call is placed. You need to ensure your client has the capability to discover the truth of the matter and determine whether prohibited conduct has occurred. You must be able to identify the problem, preserve the company's rights, and institute appropriate remedial measures - before the government investigators appear at the doorstep. And, even more importantly, when the government investigators do come knocking, you must have procedures in place that will guarantee a seamless and appropriate response.

This American Conference Institute publication on Internal Investigations for the Pharmaceutical and Medical Device Industries will provide you with a step-by-step guide for every phase of an internal investigation, tailored to the unique concerns of the drug and device industries. An outstanding faculty of leading in-house counsel and expert attorneys many of whom are former government prosecutors will lead you through the intricacies of the investigatory process and provide insights on:
  • How recent trends in government investigations of drug and device makers can help identify new areas of concern and shape the course of internal investigations
  • How to determine whether a reported matter truly is a referable compliance incident
  • How to negotiate a thorough confidentiality agreement when the waiver of attorney-client and/or work-product privilege cannot be avoided employees about self-incrimination in the interview process
  • Under which circumstances are you obligated to call the government?
  • What protocols should be established for when a government investigation commences, and how can such protocols be incorporated into existing compliance programs
  • When it's necessary to try to identify a whistleblower
  • How to develop corrective action plans that work and how to negotiate a CIA that you can live with

Contents & Contributors


TRIGGERING EVENTS: SOURCES, ANALYSIS, AND DISPOSITION
Alison Duncan, Porter Wright Morris & Arthur, LLP
Winifred M. Weitsen, Porter, Wright, Morris & Arthur, LLP

STRUCTURING THE INVESTIGATION AND CHOOSING YOUR STRATEGY: PRELIMINARY DETERMINATIONS AND PARTICULARS
Gary Giampetruzzi, Pfizer

WHEN SHOULD YOU CALL THE GOVERNMENT? THE RISKS AND BENEFITS OF VOLUNTARY DISCLOSURES TO GOVERNMENT REGULATORS
Nicholas Theodorou, Foley Hoag

PREPARE FOR AND RESPOND TO GOVERNMENT INQUIRIES
Eric A. Dubelier, Reed Smith

CORPORATE RESPONSE GUIDELINES FOR GOVERNMENT INSPECTIONS, SUBPOENAS AND SEARCH WARRANTS
Kathleen McDermott, Blank Rome LLP

WHISTLEBLOWER INVESTIGATION/CASES
Raymond A. Bonner, Esq., Sidley Austin Brown & Wood

INTEGRATING INVESTIGATION PREPAREDNESS INTO CORPORATE COMPLIANCE PROGRAMS & OTHER INITIATIVES
Wendy C. Goldstein, Esq., Epstein Becker & Green P.C.

THE DEFRAUD PRONG OF THE FEDERAL CONSPIRACY STATUTE: AN IMPORTANT ARROW IN THE GOVERNMENT'S QUIVER AGAINST HEALTH CARE FRAUD
Brien T. O'Connor, Ropes & Gray
Heather S. Crall, Ropes & Gray

THE EARLY ROUND KNOCK-OUT PUNCH TO A QUI TAM ACTION: RULE 9 (b) CHALLENGES TO RELATORS' SPECULATIVE ALLEGATIONS
Michael G. Scheininger, McKenna Long & Aldridge LLP
Mark R. Troy, McKenna Long & Aldridge LLP

GOVERNMENT INVESTIGATIONS: A VIEW FROM THE GxP SIDE
Rebecca G. Walker, Alcon Laboratories

REMEDIAL AND CORRECTIVE ACTIONS: SELF-INITIATED AND GOVERNMENT-MANDATED
Dara A. Corrigan, Arnold & Porter LLP

PRESERVING PRIVILEGE DURING AN INTERNAL INVESTIGATION
Thomas M. Gallagher, Pepper Hamilton LLP
Kathleen McDermott, Blank Rome LLP



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0