This 3-hr virtual seminar will review FDA’s IND requirements for Phase I and First-in-Man (FIM) clinical trials. It will cover the structure of an IND document and discuss granular and sectional IND creation strategies and practical approaches for an IND submission.
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. The IND application contains all available preclinical and clinical testing information, and all manufacturing information for the investigational product, along with clinical protocol, informed consent template, investigator’s brochure and other relevant information. These requirements are particularly tough for sponsors of Phase I and First-in-Man (FIM) clinical trials since these trials are usually planned early on in the development phase with limited preclinical information and may use a preliminary formulation of the investigational product.
This 3-hr virtual seminar would discuss general and specific issues to be considered for IND containing Phase I and FIM trials. This seminar is a must for those writing their first IND application, particularly those moving a new product from R&D phase into clinical phase of development. Attending this workshop is a good step toward making sure that your next IND meets FDA requirements and gets a “Safe to Proceed” letter from the FDA within 30 days from submission. This workshop contains a collection of practical tips from the trainer’s extensive IND submission experience.
Who Will Benefit:
This Webinar will provide invaluable assistance to the following personnel in the pharmaceutical and biotechnology industry planning to conduct clinical trials under a US IND:
- Study sponsors
- Regulatory affairs
- Project management
- Principal investigators and sub investigators
- Clinical research scientists
- Manufacturing personnel
- Clinical trial personnel
- IRB personnel
- Preclinical study personnel
Added by complianceonlinecom on June 1, 2012