Develop Compliant Strategies to Manage Global Patient Access to Investigational Drugs
- Philadelphia, Pennsylvania
CBI’s Expanded Access Programs (EAP) Conference is the leading source of information on Early Access, Compassionate Use and Named Patient Programs.
In October 2010, our 3rd Annual Event convened industry thought-leaders, regulatory officials and patient advocates to share lessons learned and develop best practices for providing access to investigational drugs for patients in critical need.
Increasingly, drug developers will find themselves on the receiving end of requests for access to drugs in the pipeline. Publicity generated by the release of new FDA regulations in 2009 has created greater awareness of these programs. At the same time, the increased transparency of clinical research and accessibly of powerful social media tools have led to a more informed and vocal population of patients.
In light of this intensifying demand and the benefits enabled by these programs, companies are more actively considering pre-approval or pre-launch access as part of their drug development plan in therapeutic areas with critical or unmet patient needs. These access programs can be leveraged in a number of ways, in a number of circumstances, in a single country, regionally, or worldwide.
Don’t miss the only event that helps sponsors understand the best approaches to providing access to these potentially lifesaving treatments, global regulations that govern these programs and how to partner with advocacy groups and healthcare providers to ensure success.
For more information or to register, please contact CBI toll free by phone at 1-800-817-8601 or via e-mail at firstname.lastname@example.org.