Thank you for your interest in our Clinical Discussion Forum Dinner. Please see details below and complete the form to register for our event.
Clinical Discussion Forum
So You Want a TQT Waiver? Highlights from the April 2016 FDA CSRC Meeting
Elliot Offman MSc, Senior Director, Clinical Pharmacology
Lorraine Rusch PhD, Vice President, Commercial Development
Translating the recent ICHE14 exposure response analysis proposals into
- Design considerations for the alternative to a TQT.
- Statistical PK PD analysis in a dose-escalation study to support an alternative to the TQT.
Specific regulatory questions under consideration for exposure response analysis designs:
- When is a positive control required in an alternative design cardiovascular safety assessment study?
- What potential alternatives to moxifloxacin could be considered in these alternate study designs?
- New emerging ECG biomarkers under development to characterize arrhythmia liability.
Celerion’s Clinical Discussion Forum dinner will be held at the following time and location:
Aug 2, 2016
5:30pm-6:00pm Networking, drinks and appetizers
6:15pm-8:00pm Presentation and dinner
Hotel La Jolla
7955 La Jolla Shores Dr.
La Jolla, CA 92037
Complimentary Valet Parking
RSVP by July 29