2-day In-person Seminar: Preparing IND Submissions for Conventional and Orphan Products (Pharmaceuticals)
|Event Date/Time: Oct 11, 2012||End Date/Time: Oct 12, 2012|
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, investigatorâ€™s brochure and other relevant information. For special situation such as orphan products additional considerations might apply regarding all aspects of the IND from protocol design to the background preclinical data and details of manufacturing information. 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.
Attending this workshop is a good step toward making sure that your next IND meets FDA requirements and gets a â€œSafe to Proceedâ€ letter from the FDA within 30 days from submission. Also discussed will be special situations such as INDs for orphan drugs and botanical drugs. The session topics are arranged in a logical chronology to ease the understanding of complex issues and possible solutions. This workshop contains a collection of practical tips from the trainerâ€™s extensive IND submission experience.
Who will Benefit:
- Sponsors of INDs
- Orphan drug developers
- Supervisors, and lead workers in Regulatory Affairs
- Project management personnel
- Senior management executives (CEO, COO, CFO, etc)
- Manufacturing managers, supervisors & personnel
- Clinical and preclinical laboratory managers
- People investing in FDA-regulated product development projects