Barriers to experimental treatments seem poised to fall.
Are you ready for the regulatory changes and are you developing Expanded Access best practices?
Mark your calendar for Thursday, May 10, when FDAnews presents the first-ever West Coast Symposium on Expanded Access (EAP), an all-day event for the drug, device, diagnostics and clinical trial communities.
An all-star cast of presenters will probe EAP from every angle — regulatory, scientific, business, patient safety and liability. You’ll go home ready to take full advantage of new laws and rules ranging from the 21st Century Cures Act to right-to-try state and federal legislation.
Here’s just a sampling of what you’ll hear about:
- 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 you get the real story.
- Getting Your Feet Wet: How to implement well-designed Expanded Access programs in your organization; understanding particular label and peripheral indications to identify covariates of treatment response and generate valuable RWE.
- And MUCH More!
Here’s where you and fellow attendees put the day in perspective ... where you learn what you’ve learned.
The setting is the Kimpton Sir Francis Drake Hotel in San Francisco’s storied Union Square. You’re surrounded by restaurants, shopping, museums and cultural attractions, the best the Golden Gate has to offer. Special conference room rates are historic too — historically low.
Every FDA-regulated firm involved in investigational products to treat now incurable-conditions is watching every move. This Symposium is where you discover the state of play, and hone strategies to beat the competition.