Expanded Access Programs for New Therapies
3rd October 2012 — 4th October 2012
Providing Patients Access to Drugs Prior to Approval While Obtaining Broad Exposure and Safety Data
key conference topics:
- Gain an understanding of Expanded Access Programs and their future in the pharmaceutical and biotechnology industry
- Investigate the life saving benefits Expanded Access Programs have on patients worldwide
- Execute Expanded Access Programs while minimizing risks and financial implications
- Understand regulations that must be implemented when running Expanded Access Programs both in the United States and globally
- Prepare for challenges that arise when implementing Expanded Access Programs
Around the world, many patients with terminal illnesses are unable to access the medicines they need. They may have exhausted all available commercial therapies, not have access to a clinical trial, or live in an area where a drug will not be made available through commercial routes. Expanded Access Programs serve as a vital and life saving option for these patients. Expanded Access Programs allow these patients to safely have access to drugs that are outside of the clinical trial setting; however, several concerns and challenges have arisen when utilizing them at pharmaceutical and biotechnology companies.
There are currently three different types of requests for Expanded Access Programs: Individual, Intermediate-Size, and Treatment INDs. Each type comes with a firm set of regulations and guidelines. The global understanding of these regulations and liabilities is crucial for the success of each program.
The marcus evans Expanded Access Programs for New Therapies Conference will ensure that all aspects of Expanded Access Programs are discussed in depth and will provide solutions to the challenges that Expanded Access Programs present.
Attending This Conference Will Enable You To:
1. Conduct Expanded Access Programs globally
2. Assess the utilization of Expanded Access Programs
3. Understand the impacts of third parties on Expanded Access Programs
4. Recognize considerations when operating Expanded Access Programs
5. Review financial implications and risks of Expanded Access Programs
Industry leaders attending this event will benefit from a dynamic presentation format consisting of workshops, panel discussions and case studies. Attendees will experience highly interactive conference sessions, 10-15 minutes of Q&A time after each presentation, 4+ hours of networking, and exclusive online access to materials post-event.
Expected Number of Attendees
View Conference Website: Expanded Access Programs for New Therapies
Price of Attendance