An International Society for Medical Publication Professionals Forum on New Federal Legislation will be held on January 17, 2008.
The International Society for Medical Publication Professionals (ISMPP) is hosting a one-day forum, “New Federal Legislation for Clinical Trial Registration and Results Disclosure: Implications for Publication Planning Professionals & Biomedical Publications,” on Thursday, January 17, 2008 at the Ronald Reagan Building and International Trade Center in Washington, D.C.
In September, President George W. Bush signed into law the Food and Drug Amendments Act (also known as the Food and Drug Revitalization Act), which includes the renewal of the Prescription Drug User Fee Act.
New in this bill is the section known as Title VIII—Clinical Trials Databases—which includes regulations that directly affect research investigators, sponsors, medical journals, and medical publication professionals, specifically regarding clinical trial registration and public disclosure of clinical trial results.
Passage of this recent legislation brings many significant changes. Until now, pharmaceutical companies registered information on “clinically directive” controlled trials online at http://www.ClinicalTrials.gov , largely in response to major medical journal editors’ policy. Federal legislation only required registering trials that assessed efficacy of an intervention in serious or life-threatening diseases.
Now, not only must (nearly all) trials be registered, but their results must be disclosed publicly and within a timeframe that is dictated by the new legislation. Noncompliance may result in significant penalties.
To help its membership be prepared for the changes, ISMPP has assembled expert speakers who will share their insights on this crucial new legislation.
The speakers for the ISMPP forum include:
- Alan Goldhammer, PhD, Associate VP, Regulatory Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA);
- Trish Groves, MBBS, MRCPsych, Deputy Editor, British Medical Journal (BMJ);
- Kenneth A. Jamerson, MD, Professor, Department of Internal Medicine, University of Michigan Health System
- Scott M. Lassman, Esq., Partner, WilmerHale (former legal counsel to PhRMA);
- Donald A.B. Lindberg, MD, Director, National Library of Medicine;
- Amy Muhlberg, PhD (representing U.S. Senator Mike Enzi, R-Wyoming);
- Frank W. Rockhold, PhD, SVP, Biomedical Data Sciences, GlaxoSmithKline, and
- Theresa A. Toigo, RPh, Director, FDA Office of Special Health Issues
The expert faculty will address key areas of importance for ISMPP members, including
- How will the law affect abstract submissions to clinical congresses and manuscript submissions to peer-reviewed journals?
- How will peer-reviewed journals respond?
- Changes in day-to-day publication planning and development?
- Roles of the NIH and FDA in implementation of the legislation.
Registration for the forum is $495, and includes all meals and breaks that day. In order to register, participants must be a member of ISMPP (2008 member dues are $195). Registration is available online at http://www.ismpp.org , and by phone at 1-888-252-7904.
About ISMPP:
The International Society for Medical Publication Professionals (ISMPP) is an independent, non-profit professional association with over 600 members from the pharmaceutical, medical device, and biotechnology industries; publication planning and medical communications companies; medical writers; academia; and medical journal staff, including editors and publishers. The association’s goals are to support the education needs of publication professionals and to develop best practices that ensure the rigorous maintenance of all ethical standards for reporting the results of medical research.
Additional information about ISMPP is available at http://www.ismpp.org.
