The Pharmaceutical Industry's Guide to

Document Management and E-Discovery

Tuesday, April 19, 2005

About

Corporations today face an increasingly complex landscape with respect to creating document management programs, implementing those programs and ensuring that those programs are being adhered to. The risks associated with failing to meet your legal obligations to retain (and in case of litigation, produce) documents can be severe. Complying with these retention and discovery obligations are particularly great for the record intensive pharmaceutical industry which is under constant scrutiny not only from various government regulators, but also from actual and potential adversaries in high-stakes litigation.

Accordingly, pharmaceutical companies must be extra vigilant in managing all forms of records. This task continues to become increasingly difficult as a result of the ever increasing volume of communications, the continuing evolution of electronic and wireless communications, constant threat of litigation or investigation, and frequent changes in the (sometimes murky) law. Recent high profile cases have made it abundantly clear that the millions of e-mail messages and other corporate communications that flow through today's organizations can be ticking time-bombs. Because all it takes is one damaging document to cause great harm - both in terms of civil (and possibly criminal) penalties as well as negative publicity - anything less than complete compliance can be dangerous. And because most professionals working in this industry face many competing demands for their attention, it is common for record compliance issues to fall by the wayside.

To guide you through this challenging environment, American Conference Institute has developed this high-level publication focusing on the practical realities of understanding and complying with document retention and e-discovery obligations. It will provide you with valuable information and practical strategies on:

Monitoring and auditing your document management practices to ensure continuing compliance
Overcoming document management challenges created by the pharmaceutical regulatory landscape
Strategies for dealing with the increasing volume of electronic and wireless communications
How the proposed changes to the FRCP and recent cases affect your obligations
Best practices in issuing and managing litigation hold notices and effective litigation tactics

Contents & Contributors

About

Corporations today face an increasingly complex landscape with respect to creating document management programs, implementing those programs and ensuring that those programs are being adhered to. The risks associated with failing to meet your legal obligations to retain (and in case of litigation, produce) documents can be severe. Complying with these retention and discovery obligations are particularly great for the record intensive pharmaceutical industry which is under constant scrutiny not only from various government regulators, but also from actual and potential adversaries in high-stakes litigation.

Accordingly, pharmaceutical companies must be extra vigilant in managing all forms of records. This task continues to become increasingly difficult as a result of the ever increasing volume of communications, the continuing evolution of electronic and wireless communications, constant threat of litigation or investigation, and frequent changes in the (sometimes murky) law. Recent high profile cases have made it abundantly clear that the millions of e-mail messages and other corporate communications that flow through today's organizations can be ticking time-bombs. Because all it takes is one damaging document to cause great harm - both in terms of civil (and possibly criminal) penalties as well as negative publicity - anything less than complete compliance can be dangerous. And because most professionals working in this industry face many competing demands for their attention, it is common for record compliance issues to fall by the wayside.

To guide you through this challenging environment, American Conference Institute has developed this high-level publication focusing on the practical realities of understanding and complying with document retention and e-discovery obligations. It will provide you with valuable information and practical strategies on:

Monitoring and auditing your document management practices to ensure continuing compliance
Overcoming document management challenges created by the pharmaceutical regulatory landscape
Strategies for dealing with the increasing volume of electronic and wireless communications
How the proposed changes to the FRCP and recent cases affect your obligations
Best practices in issuing and managing litigation hold notices and effective litigation tactics

Contents & Contributors


THE DISCOVERABILITY OF COMPUTERIZED INFORMATION
Francis J. Burke, Jr., Steptoe & Johnson L.L.P.

RECORDS MANAGEMENT AND BEST PRACTICES IN E-DISCOVERY
Robert D. Owen, Fulbright & Jaworski L.L.P.
Charlene Allyson Brownlee, Fulbright & Jaworski L.L.P.

DEVELOPING AND IMPLEMENTING EFFECTIVE DOCUMENT RETENTION MANAGEMENT POLICIES
Charlene Allyson Brownlee, Fulbright & Jaworski L.L.P.

HANDLING DOCUMENT MANAGEMENT CHALLENGES UNDER THE PHARMACEUTICAL INDUSTRY REGULATORY STRUCTURE: SUMMARY OF STATUTES, REGULATIONS AND POLICIES
Harman Avery Grossman, Johnson & Johnson
John Fleder, Hyman, Phelps & McNamara, P.C.
Shawn M. Brown, Hyman, Phelps & McNamara, P.C.

BEYOND COST-SHIFTING: DEVELOPING, IMPLEMENTING AND DEFENDING YOUR COMPANY'S ELECTRONIC RECORDS RETENTION POLICY
Jeffrey S. Follett, Foley Hoag LLP
Brian C. Carroll, Foley Hoag LLP

USING E-DISCOVERY TO YOUR ADVANTAGE IN LITIGATION
Joan E. Feldman, Computer Forensics Inc.

SAFE COMMUNICATION: GUIDELINES FOR CREATING CORPORATE DOCUMENTS THAT DON'T BRING DOWN THE COMPANY
Joseph Falgiani, Sedgwick, Detert, Moran & Arnold

MANAGING AND DISCOVERING E-DATA ON AN INTERNATIONAL SCALE
Dorothy Dale Pollack, CRM, CA, GlaxoSmithKline

ELECTRONIC DISCOVERY: A SURVEY OF RELEVANT LAW AND RECENT DEVELOPMENTS
Paul M. Robertson, Bingham McCutchen LLP
Lawrence T. Stanley, Jr., Bingham McCutchen LLP

PROPOSED MODIFICATIONS TO THE FEDERAL RULES OF CIVIL PROCEDURE DESIGNED TO ADDRESS ELECTRONIC DISCOVERY
Adam I. Cohen, Weil Gotshal & Manges LLP

PRACTICAL CONSIDERATIONS IN DATA COLLECTION
Sean Flynn, LexisNexis Applied Discovery

BEST PRACTICES IN ISSUING AND MANAGING LITIGATION HOLD NOTICES
Robert D. Owen, Fulbright & Jaworski L.L.P.

USING E-DISCOVERY TO YOUR ADVANTAGE IN LITIGATION
Brian Coggio, Orrick, Herrington & Sutcliffe
Todd L. Krause, Orrick, Herrington & Sutcliffe

ELECTRONIC DISCOVERY AND THE UNIQUE CHALLENGES FACING PHARMACEUTICAL COMPANIES
Dean A. Gonsowski, Navigant Consulting, Inc.

DISCOVERY OF DIGITAL INFORMATION
Honorable Ronald J. Hedges, District of New Jersey

ETHICAL ISSUES IN ELECTRONIC DISCOVERY
Steven C. Bennett, Jones Day

SELECTING THIRD-PARTY SYSTEMS AND TECHNOLOGIES FOR DOCUMENT MANAGEMENT AND E-DISCOVERY: FINDING THE BEST FIT
Kevin Esposito, Pfizer Inc.
Rachelle DeGregory, Esq., LexisNexis Applied Discovery
Laura M. Kibbe, Pfizer Inc.
George J. Socha, Jr., Socha Consulting LLC

SUCCESSFULLY NAVIGATING GOVERNMENT INVESTIGATIONS
D. Jacques Smith, Arent Fox PLLC
John N. Nassikas, III, Arent Fox PLLC
Breckinridge L. Willcox, Arent Fox PLLC



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