IND Applications for the US FDA - Webinar By ComplianceOnline (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Jul 27, 2011||End Date/Time: Jul 27, 2011|
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 â€œSafe to Proceedâ€ 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.
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