6-hr Virtual Seminar: FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

This Course covers FDA’s statutory and regulatory requirements governing the development and use of investigational drug products for first-in-human clinical trials. It will provide a comprehensive look at the Current Good Manufacturing Practices (cGMPs) applicable to early stage human clinical testing from beginning to end. Several general categories will be covered including amongst others, Preclinical Testing Considerations, cGMPs for Phase I Investigational Drugs, the Regulation of Biologics for Investigational Use, and Human Clinical Trial Considerations. Attention will also be given to the specific rules applicable to each of these categories. Finally, the presenter will offer strategies for compliance with applicable Phase I Clinical Testing obligations and for mitigating the risk of Agency enforcement action. A time for participant questions will be provided.

Attendees will leave the Course clearly understanding the Processes and cGMP Requirements for parties sponsoring and conducting “first-in-human” Phase I Clinical Trials. The webinar is intended to provide participants with an understanding of:

• How early stage human clinical trials are regulated in the United States.
• FDA’s requirements governing the development and use of investigational drug products and biologics for Phase I / First-In-Human Clinical Trials
• How to design and implement a Manufacturing Plan and Quality Controls to ensure the safety of subjects while complying with FDA’s regulatory requirements
• Reliance on preclinical testing as the building block for future human testing
• Special considerations for Sterile Products/Aseptically Processed Products 
• Agency’s current focus on Pharmacovigilance
• Recent FDA enforcement action in the space and how to mitigate the risk of being the subject of such action

• Statutory and Regulatory Overview
• Investigational New Drugs vs. Approved Drug Product
• Preclinical & Clinical Trial Phases
• General IND Regulations (21 CFR Part 50)

• Good Laboratory Practices (“GLP”)
• Nonclinical Studies
• Protocol Design 
• Pharmacology Studies
• Toxicology Studies
• Other Studies  

• Personnel 
• QC Function  
• Facility and Equipment 
• Control of Components, and Containers and Closures 
• Manufacturing and Records 
• Laboratory Controls 
• Testing 
• Stability 
• Packaging, Labeling and Distributing 
• Recordkeeping

• Overview
• Composition, Quality, and Safety
• Product Characterization
• Personnel
• Facility and Equipment
• Manufacturing Process
• Quality Controls
• Safety-Related Functions / Purposes
• Testing 
• Recordkeeping
• Product Modifications 

• Human Subject Protection (21 CFR Part 50)
• General Overview
• Informed Consent
• Financial Disclosures (21 CFR Part 54)
• Institutional Review Boards (21 CFR Part 56)
• Clinical Investigators 
• Additional IND Requirements
• Clinical Trial Design
• Conducting Trials in Humans
• Pharmacovigilance 

• Facility Inspections 
• Enforcement Action Types
• Recent Enforcement Action Case Studies
• Compliance Strategies for Mitigating Risk