2-Day Virtual Training (February 16-17, 2023)
(Attend LIVE or Access Recording)

FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials

Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. 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. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Learning Objectives:
  • Learn about FDA's regulations and Guidance Documents for Phase I clinical trials
  • Key elements of GMP for Phase I clinical trials
  • Best Practices for manufacturing drugs and biologics for early clinical trials
  • Components for the CMC information for INDs
  • Raw material management
  • Risk management for manufacturing early clinical stage material
  • Outsourcing early stage manufacturing
Who Will Benefit:
  • Directors
  • Managers
  • Supervisors, and lead workers in Regulatory Affairs
  • Quality Assurance and Quality Control
  • Workers who will prepare GMP documents for early phase products as well as those who will review these documents
  • Regulatory affairs workers who will need to deal with submissions covering early phase products

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com