2-Day Virtual Training (August 10-11, 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 can be a complex and costly endeavor for developers. These first-in-man and pilot clinical trials, usually conducted with a small number of healthy participants, are primarily aimed at establishing safety. Therefore, they do not require a significant amount of investigational material. Recognizing this, the US FDA allows developers to test early-stage investigational products under relaxed GMP requirements.
 
During our comprehensive workshop, we will delve into the current regulations, guidance documents, and regulatory strategies that are available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. This training will equip you with valuable insights on how to ensure the quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing.
 
By participating in this training, you will gain a deep understanding of the FDA's GMP expectations for Phase I and First-in-Man Clinical Trials. You will learn practical strategies that will enable you to navigate the regulatory landscape more effectively, ensuring FDA compliance while optimizing your resources.
​Why should you attend:
  • ​​Understanding the manufacturing requirements for early-stage clinical trials.
  • Exploring logistical challenges and supply management for early-stage investigational products.
  • Requirements for stability testing, storage, shipping, labeling, and documentation
  • Examining case studies to provide perspectives for different classes of products.
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