Clinical and regulatory experts will share their experience on June 6th to help you understand the evolving regulatory requirements and to better prepare for a successful FDA submission. The panel discussion will be followed by a networking session with food and drinks. Click here for event details.

How can clinical trial professionals overcome the increased complexity and cost of clinical trials?

Which best practices help adapt to the new trends and FDA requirements?

What are the do’s and don’ts for a successful FDA submission?
 

Abstract: FDA review is the final and most important step the in clinical trial process. In the last decade, the number of approvals per 1,000 US-based clinical trials has declined from 7.5 in 2004 to 3.1 in 2010. Simultaneously, industry experts are facing increased complexity and cost when managing clinical trials. A 2010 PhArma report argues that between 2000 and 2007, the median number of procedures per clinical trial increased by 49%. To give you the best understanding of FDA new rules, our top-tier industry experts will address the following topics:

• Compliance. Industry professionals need to stay on top of the latest FDA regulations to avoid out of compliance submissions.
• Safety. FDA regular warnings make clinical data safety a stumbling point of any clinical trial.
• Standardization. To date, 60% of FDA submissions are done with CDISC standards. As FDA is becoming more and more involved in CDISC standards, adopting clinical standards increases the speed of FDA review.
• Risk assessment. One of the FDA’s growing concern is to ensure that high-risk drugs and medical devices generate clinically significant results. This makes clinical data accuracy more important than ever before.
• Communication. Our experts will share best practices for a smooth collaboration with all divisions of the FDA.

Speakers:

Dr. Urte Gayko ​Nodality     VP, Regulatory and Clinical Affairs   Read bio

Dr. Christine Conroy Affymax     VP, Regulatory Affairs and GCP Compliance   Read bio

Dr.Sandra Nino-Siddens ​Geron Corporation     Executive Director, Regulatory Affairs   Read bio

Dr. Anne-Marie Duliege Affymax     Chief Medical Officer Moderator   Read bio

Event details:

• Wednesday, June 6th - 6.00pm - 8.00pm PST
• 4000 Shoreline Court, Suite 210, South San Francisco, CA 94080
• Registration is free of charge before May 26^th included and $20 after this date.

Contact information: Sophie McCallum, Marketing Manager at Clinovo, sophie.mccallum@clinovo.com

An event sponsored by: