ComplianceOnline, OnlineEvent
2012-10-19
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. Agenda:(PDT) - 10.00am PDT to 11.30am (Session 1)
- 11:30am - 12.00 Noon (Break)
- 12.00pm to 1.30pm (Session 2)
Areas Covered in the Seminar: Session 1: What you must know about an IND: Content and Format of IND sections Session 2: Practical Issues and Potential Solutions for an IND for FIM and Phase I Clinical Trials 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
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