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32676 Conferences

IND Applications for the US FDA - Webinar By ComplianceOnline

Added by Referral on 2011-07-01

Conference Dates:

Start Date Start Date: 2011-07-27
Last Date Last Day: 2011-07-27

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

All sponsors of clinical trials in the US for drug and biologics have to first file an Investigational New Drug (IND) application with the FDA containing extensive information in support of the proposed clinical trial. Each year hundreds of new INDs are submitted to the FDA, about half of which are not cleared to proceed with the planned clinical trial within the 30 day review period mostly due to deficiencies in the information provided in the IND. Failure to submit a satisfactory IND could lead to FDA imposing a clinical hold on the clinical trial in turn adding additional expense and delay to a clinical trial.

Attend this full day virtual workshop to understand how to make sure, your next IND meets FDA requirements and gets a “Safe to Proceed” letter from the FDA within 30 days from submission. This virtual workshop contains a collection of practical tips from the trainer's extensive IND submission experience.

How It Works :

The virtual work shop has a series of modules and our speaker, Dr. Mukesh Kumar , will deliver the modules using PowerPoint slides. At the end of each module, there is an interactive portion where participants can ask questions and clarify information. These modules may include multiple-choice questions to help participants assure they understand the material. Some of the modules contain exercises for participants that help illustrate the points covered and further increase learning. The interactive portion includes a discussion of the questions and exercises.
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