FALLS CHURCH, Va. (PRWEB) April 24, 2018
The West Coast Symposium on Expanded Access
Building Expanded Access into the Clinical Development Process
**Presented by FDAnews**
May 10, 2018 – San Francisco, CA
http://www.fdanews.com/expandedaccess2018
The barriers to experimental treatments are breaking down. Are clinical trial operators ready for the opportunity?
Mark the calendar for FDAnews’ first-ever West Coast Symposium on Expanded Access an all-day event to show where future opportunities and pitfalls lie.
An all-star cast of presenters will probe expanded access from every angle including: regulatory, scientific, business, patient safety and legal liability. Attendees will go home with a real-world understanding of the current and future regulatory landscape, ready to take full advantage of new laws, including state right to try laws and the 21st Century Cures Act.
Here’s just a sampling of what will be covered:
- Government Actions: President Trump showed his support for “right to try” legislation in his State of the Union message. Discover how this may affect Expanded Access.
- What’s Happening Now: Case studies of work under way in real time at drug, device and diagnostics firms.
- Real World Evidence/Real World Data: RWE and RWD are transforming data collection at FDA-regulated companies, nowhere more than in Expanded Access data collection and its application to clinical processes.
- Best Practices: Better management of planning and operational concerns posed by Expanded Access programs, including implementing best practices.
- Debunking Myths: Pre-approval access is not well understood. Here’s where to get the real story.
- Getting Started: How to implement well-designed Expanded Access programs; understanding particular label and peripheral indications to identify covariates of treatment response and generate valuable RWE.
- And much More!
Meet the Conference Leader
Jess Rabourn is co-founder of the National Board of Early Access Medicine, the longest-standing U.S. organization focused on pre-first-approval access. Producer of the Expanded Access Summit, which establishes best industry practices for integrating EAPs into the drug development process. Industry consultant and founder of WideTrial, a specialty platform for third-party sponsorship of EAPs. Frequent speaker at medical conferences.
Who Will Benefit
Drug/biologics and device/diagnostics makers, clinical trial sponsors, disease foundations, indeed, all organizations involved in investigational therapeutics or diagnostics to address unsolved health conditions are potential attendees.
- Executive suite
- New product strategists
- Clinical trials/clinical development
- CRO/strategic planning/business development
- CMO/medical affairs
- Regulatory/compliance
- Project management
- Risk management
- Quality control/GMP/cGMP
- GC/legal affairs/outside counsel
- Physicians
- Consultants
Conference Details:
The West Coast Symposium on Expanded Access:
Building Expanded Access into the Clinical Development Process
**Presented by FDAnews**
May 10, 2018 – San Francisco, CA
http://www.fdanews.com/expandedaccess2018
Tuition: $897
Significant team discounts are available.
Easy Ways to Register:
Online: http://www.fdanews.com/expandedaccess2018
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
