The 2005

Drug Safety Congress

The Premier Legal & Regulatory Drug Safety Event

Thursday, September 29, 2005

About

The Drug Safety Bill has been introduced in the Senate.
The Drug Safety Oversight Board has been formed.
The FDA "Drug Watch" website will soon launch.
Is your company prepared for the impact of these proposed legislative changes and regulatory reforms and those which are yet to follow?


The pharmaceutical industry is facing severe public and political scrutiny over the safety of several well-known blockbuster drugs. Congress is taking the industry and the FDA to task - questioning the closeness of their relationship - as it seeks answers to whether a true conflict of interest exists with respect to drug approvals and safety monitoring.

Lawmakers from both parties are questioning the current structure of the FDA's safety oversight. Can the Office of Drug Safety's powers be adequately enhanced through the creation of an independent safety review board? Is the creation of a new Center for Postmarket Drug Evaluation and Research the only way to minimize - if not solve - the problem of product withdrawals and seemingly endless black box warnings?

Meanwhile, the FDA is looking inward, examining its own safety initiatives. The agency recently released its Final Risk Minimization Guidance, and has announced the membership of the new Drug Safety Oversight Board. The FDA also has released new information about postings on its Drug Watch Website, which will launch soon.

As legislators and regulators try to find a balance between safety and efficacy, the industry has its own concerns. If R&D is subject to unreasonable restraints, getting new products approved will be all the more difficult, if not impossible. Moreover, the steady increase in product liability suits since the beginning of the current imbroglio means the industry must be prepared for time-consuming and expensive litigation.

What course of action should your company take in this dynamic atmosphere of legal, regulatory and political change?

In this unsettled, high-risk and high-stakes environment, counsel, executives and safety officers for the pharmaceutical industry must have an in-depth and complete understanding of the latest legal, regulatory, legislative and political developments affecting drug safety today. The 2005 Drug Safety Congress publication will give you the latest information from your colleagues who are on the forefront of the current safety protocol controversy, as well as the reform movement.

Contents & Contributors

About

The Drug Safety Bill has been introduced in the Senate.
The Drug Safety Oversight Board has been formed.
The FDA "Drug Watch" website will soon launch.
Is your company prepared for the impact of these proposed legislative changes and regulatory reforms and those which are yet to follow?


The pharmaceutical industry is facing severe public and political scrutiny over the safety of several well-known blockbuster drugs. Congress is taking the industry and the FDA to task - questioning the closeness of their relationship - as it seeks answers to whether a true conflict of interest exists with respect to drug approvals and safety monitoring.

Lawmakers from both parties are questioning the current structure of the FDA's safety oversight. Can the Office of Drug Safety's powers be adequately enhanced through the creation of an independent safety review board? Is the creation of a new Center for Postmarket Drug Evaluation and Research the only way to minimize - if not solve - the problem of product withdrawals and seemingly endless black box warnings?

Meanwhile, the FDA is looking inward, examining its own safety initiatives. The agency recently released its Final Risk Minimization Guidance, and has announced the membership of the new Drug Safety Oversight Board. The FDA also has released new information about postings on its Drug Watch Website, which will launch soon.

As legislators and regulators try to find a balance between safety and efficacy, the industry has its own concerns. If R&D is subject to unreasonable restraints, getting new products approved will be all the more difficult, if not impossible. Moreover, the steady increase in product liability suits since the beginning of the current imbroglio means the industry must be prepared for time-consuming and expensive litigation.

What course of action should your company take in this dynamic atmosphere of legal, regulatory and political change?

In this unsettled, high-risk and high-stakes environment, counsel, executives and safety officers for the pharmaceutical industry must have an in-depth and complete understanding of the latest legal, regulatory, legislative and political developments affecting drug safety today. The 2005 Drug Safety Congress publication will give you the latest information from your colleagues who are on the forefront of the current safety protocol controversy, as well as the reform movement.

Contents & Contributors


DRUG SAFETY AFTER VIOXX
Daniel E. Troy, Sidley Austin Brown & Wood LLP

DRUG SAFETY CONCERNS IN CLINICAL TRIALS
Douglas B. Farquar, Hyman, Phelps & McNamara

ADDRESSING SAFETY IN NDA AND BLA SUBMISSIONS
Edward B. Berg, Cephalon, Inc.

BUILDING SAFETY INTO THE NDA: THOUGHTS ON FDA'S RISK MANAGEMENT TOOLS
Peter O. Safir, Covington & Burling

ENSURING A PROPER RISK-BENEFIT RATIO AFTER APPROVAL: POST-MARKETING REGULATION
Christina M. Markus, King & Spalding LLP

OVERVIEW OF FDA'S 2005 RISK MANAGMENET GUIDANCE
Mark S. Brown, King & Spalding LLP

SAFETY ISSUES FOR BIOTECHNOLOGY THERAPIES
W. Charles Lucas, Biotechnology Industry Organization

USE OF CLINICAL TRIALS DATA TO COUNTER POTENTIAL POST-MARKETING CLAIMS
Joseph Hetrick, Dechert LLP
Ken Baum, M.D., J.D., Wiggin and Dana LLP

DRUG SAFETY AND PRODUCT LIABILITY
David V. Ceryak, Eli Lilly and Company

DRUG SAFETY AND PRODUCT LIABILITY
Michael J. Harrington, Eli Lilly and Company

DRUG SAFETY HARMONIZATION
David I. Goldsmith, MD, FISPE, Goldsmith Pharmacovigilance & Systems



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0