Clinical Data Disclosure Summit

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.

It is now ExL Pharma’s 5th year of providing the industry with an interactive forum where professionals can evaluate the current issues and discuss best approaches for overcoming the challenges in this changing regulatory environment. At the 5th Clinical Data Disclosure Summit, professionals will be able to ascertain variances in the guidances and provide best practices and expertise to successfully handle the evolution of clinical transparency.

We hope you can join us for this valuable educational and networking opportunity.

Lauren Packer                         
Conference Producer                
ExL Pharma

Kristen Hunter
Team Leader, Production
ExL Pharma