An FDA Insider's Guide to Crisis Management
Order now for mission-critical strategies on pharma and medical device crisis management.
Pharmaceutical and medical device companies are subject to higher scrutiny by the FDA as well as the general public. Any negative occurrence can mushroom into a crisis — if it's mismanaged.
It's critical in today's world to have a crisis management plan ready. In this industry, crises happen daily and waiting until a problem occurs can be fatal. Just in the past couple of months …
- The DOJ subpoenaed Zimmer Holdings Inc. in an investigation of possible federal criminal violations involving the manufacture and sale of orthopedic implant devices
- A class action lawsuit was filed against NPS Pharmaceuticals claiming investors were misled about the prospects of NPs osteoporosis drug Preos
- Agents for the Federal Bureau of Investigation raided the office of Bristol-Myers Squibb's CEO Peter Dolan as part of a criminal antitrust probe
- Troubles continue for Neurocrine Biosciences in the wake of a regulatory delay of the insomnia drug Indiplon as the company announces it is eliminating its sales staff
- TeGenero filed for bankruptcy just months after its UK-based clinical trial for its immune-boosting drug TGN1412 caused severe adverse reactions in six healthy male volunteers
A mismanaged crisis can result in severe damage to your company's reputation, lost revenue, or jail time for anyone involved in a cover-up. Be prepared handle any crisis before it occurs.
In this 90-minute audio CD/transcript, internationally known consultant, author and former FDA Associate Commissioner Wayne Pines, and former HHS Deputy Assistant Secretary for Public Affairs William Pierce delivers nine key principles for developing and implementing a systematic and effective crisis management strategy specifically for FDA-regulated companies. He will demonstrate through case studies, what to do and what not to do in a crisis. In addition, Wayne will outline the best practices for establishing a case management committee, defining and defending communication channels. Plus you will discover how to coordinate with the FDA during a crisis.You will discover how to:
- Create an effective crisis management committee: how to staff the committee, day-to-day management basics, how to set and meet goals
- Establish a "media outreach" system: why it matters and how to execute a plan
- Target and prioritize audiences that need to hear from you during a crisis:
- Which message to communicate to each group
- The right person to deliver that message
- Determine strategies for selecting and soliciting outside experts to help in managing a crisis
- Interact with the FDA during a regulated company crisis
- Deal with concerns from international audiences
- Apply working tips and strategies for crisis management
- And more
Don't miss this great opportunity to get expert advice directly from an internationally known consultant and author on crisis management.
Wayne L. Pines is an internationally known consultant on crisis management — including regulatory and media strategies — involving pharmaceuticals, biological products and medical devices. Wayne formerly was Associate Commissioner for Public Affairs at the FDA, where he served as chief spokesperson. Today he helps companies seeking to navigate their products through the FDA approval process, and conducts training programs for companies on crisis management and on advertising/promotion regulations. He also conducts programs for corporate executives on how to deal with the media or with FDA-related issues.
Wayne is the author or editor of ten books about FDA regulatory processes, healthcare crisis management and the FDA itself. He is a frequent public speaker and has published dozens of articles in the professional press. He has chaired meetings for professional organizations on advertising issues, risk management, crisis management, and FDA processes. He is President of Regulatory Services and Healthcare at APCO Worldwide, an international consulting firm.
The next edition of Wayne Pines' book, Communicating in a Healthcare Crisis, is scheduled for release in December 2006 by FDAnews.
William Pierce, vice president of APCO Worldwide, specializes in providing strategic advice and counsel on health care policy development, Medicare and Medicaid policy, the FDA regulatory process, Bio-terrorism, public health and the CDC and Social Security reform. His work includes media relations, policy development, issues advocacy, message development, and crisis communications. Previously, Bill served as the Deputy Assistant Secretary for Public Affairs at the Department of Health and Human Services during President George W. Bush’s first term. Bill was a spokesman and key public affairs advisor for HHS on new stem cell policy, the 9/11 and anthrax attacks, Medicare and Medicaid reform, and the 2004 flu vaccine shortage, among other issues and events.
Prior to HHS, Bill worked as the Director of Public Affairs for Blue Cross/Blue Shield, Director of Communications for the National Taxpayers Union, and as press secretary for two members of Congress.
The strategies in this audio CD/transcript will benefit professionals working in drug, biotech, biologic, device and diagnostics companies, including:
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