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ACI : Conference-Papers : 2006 : Internal Investigations for the Pharmaceutical & Medical Device Industries
Internal Investigations for the Pharmaceutical & Medical Device IndustriesThursday, April 27, 2006
AboutLearn the Art of Conducting an Effective and Thorough Internal InvestigationThe 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:
Contents & ContributorsAboutLearn the Art of Conducting an Effective and Thorough Internal InvestigationThe 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:
Contents & ContributorsTRIGGERING 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 |
Date: Thu, Apr 27, 2006 Location:
New York, NY Pricing:
Option 1: Bundle Package
Binder & CD-ROM Save 299 - Best Value! Total: $699 + $9.95 (shipping & handling) + applicable taxes Option 2: CD-ROM
CD-ROM of program proceedings Total: $499 + $9.95 (shipping & handling) + applicable taxes Option 3: Binder
Printed copy of program proceedings Total: $499 + $9.95 (shipping & handling) |
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