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3-hr Virtual Seminar: IND Applications for Phase I Studies

Date: 19-Oct-12 to 19-Oct-12
Location: Online Event / California / United States
Category: Education Healthcare & Pharmaceuticals Conferences & Trade Fairs

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.

Visitors

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.

Exhibitors

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues.

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