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3-hr Virtual Seminar: IND Applications for Phase I Studies
Friday, October 19, 2012 from 10:00 AM to 1:00 PM (PDT)
Palo Alto, CA
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.
- 10.00am PDT to 11.30am (Session 1)
- 11:30am - 12.00 Noon (Break)
- 12.00pm to 1.30pm (Session 2)
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.