News
EXL 6TH CLINICAL DATA DISCLOSURE CONFERENCE
TBD
Beginning in 2007, the Food and Drug Administration Act (FDAAA) required drug and device companies to register their investigational studies in clinical trial databases. FDAAA stated that Clinicaltrials.gov was the repository that must be used and required the registration of new clinical studies and the disclosure of results for completed studies. The principle behind clinical trial reporting is to increase transparency into the drug and device development process, and by doing so, alleviate any doubts the public may have about the conduct of clinical trials, and safety of drug and device companies’ products.
In recent years, the industry has encouraged greater transparency in the drug and device development process. New laws and guidances from regulatory agencies and health organizations require that drug and device companies provide transparency into their clinical studies. Clinical disclosure is becoming increasingly crucial and is a necessity for companies to understand and comply.
We hope you can join us for this valuable educational and networking opportunity.
ISMPP 7th ANNUAL MEETING
TBD
The International Society for Medical Publication Professionals (ISMPP) is pleased to announce the opening of registration for its 6th annual meeting, “Delivering Value and Driving Advocacy in Medical Publications.” The meeting will run from April 19 to 21, 2010, in Arlington, VA, at the Crystal Gateway Marriott.
ISMPP has created an exciting program that focuses on two of the most critical factors that are relevant to all who work in medical publications — value and advocacy. Both are integral to ensuring that medical publication professionals can continue to contribute to the dissemination of the results of clinical trials with accuracy, transparency, and integrity.
To address these issues, this year’s plenary sessions will explore such topics as the impact of guidelines and regulations, including GPP-2; ISMPP’s advocacy activities; and insights of journal editors. Unique this year to the journal editors’ segment is the rollout of an authors’ tool kit that has been developed by editors of top-tier medical journals. As in the past, the meeting will also offer half-day pre- and post-conference workshops and original ISMPP member research presentations.
CBI’s 6th Forum on Clinical Trial Registries and Results Databases:
Best Practices for Clinical Data Disclosure within an Evolving Global Regulatory Framework
TBD
Over the last several years, the global regulatory framework for clinical trial transparency has evolved considerably. With rule-making expected domestically, the highly anticipated release of EudraCT Version 8 and the continued proliferation of national registries around the globe all planned for 2010, this trend is sure to continue.
In order to remain compliant, those charged with trial registration and results disclosure must capitalize on valuable opportunities to interact with likeminded professionals and develop best practices for a global compliance program.
As one of the industry’s most revered forums since 2006, CBI’s 5th Clinical Trial Registries and Results Databases Conference boasts the perfect mix of topics in 2010.
In addition to expert perspectives from U.S. and European based speakers, the program also features representatives from national registries such as Chile, India and the Netherlands. Register today and don’t miss your only opportunity to obtain essential information directly from the source!