Event Detail
2-day In-person Seminar: FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
February 7 - 8, 2013 - San Diego CA US
ComplianceOnline
referral@compliacneonline.com
Phone: +1-650-620-3915
Course Description: Phase 1 clinical trials are conducted in very small number of healthy participants with lower doses basically to establish safety and hence do not need a significant amount of investigational material. Manufacturing an investigational product for the initial pilot clinical trials would give a considerable logistical and financial challenge to manufacturers. USFDA allows the manufacturers to test such an early stage investigational product under relaxed Good Manufacturing Practices (GMP) requirements. This course will help to understand regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Course Objective: The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. The two day interactive seminar will focus on the current regulation, guidance documents and regulatory strategies available for manufacturing of an early development stage product for Phase I clinical trials. The instructor will also discuss about the logistical issues with the supply of an early stage investigational product. Attendees will get an understanding on the requirements for stability testing, storage, shipping, labeling and documentation of an early stage investigational product. Following important contents will be covered in the two day seminar: • Perspectives for different classes of early stage investigational products • Good manufacturing practices for different products: drugs to medical devices • Moving a Product out of R&D o Issues with research grade material used for laboratory and non-clinical testing • Planning the Chemistry, Manufacturing & Controls (CMC) for a potential Investigational New Drug (IND) • Raw Material Management issues with the early stage products • Clinical Trials with Early Stage Products o Institutional review board (IRB) issues with early stage and first-in-man clinical trials o Informed consent requirements for early stage INDs • Outsourcing Early Stage Manufacturing o Pilot scale manufacturing requirements o Logistics of using contract manufacturing organizations for early stage products