6 Hours Virtual Seminar: FDA's GMP Expectations for Phase 1 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.

Course Objective

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

Course Outline

10:00am – 12:00pm Session 1

I. Overview

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

II. Preclinical Trial Considerations

Good Laboratory Practices ("GLP")
Nonclinical Studies
Protocol Design
Pharmacology Studies
Toxicology Studies
Other Studies

12pm- 1pm Lunch

1pm - 2:30pm Session 2:

III. Recommended cGMP for Phase I Investigational Drugs

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

IV. Biological and Biotechnological Products

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

2:30pm - 2:45pm Break

2:45pm - 4pm Session 3:

V. Sterile Products/Aseptically Processed Products

VI. Human Clinical Trial Considerations

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

VII. Regulatory Compliance

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

VIII. Questions

Target Audience

Clinical Operations Staff
Project Team Members
Quality Assurance, Monitors, CRAs
Regulatory Affairs
Investigators & Site Study Staff
Clinical Trial Supply
CROs, Consultants, Insurer
Directors
Manager
Supervisors
Lead workers in Regulatory Affairs Quality Assurance and Quality Control
Workers who will prepare GMP documents for early phase products

Webinar Events

Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

$1299

Recorded video

Recorded video session

$1049

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Speaker: Karl M. Nobert,

Karl M. Nobert focuses his practice on the representation and counseling of clients in the food and drug industry including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine, medical devices, food and dietary supplements. Karl also assists clients with the preparation of FDA submissions including human and veterinary new drug and generic drug applications; 510(k) premarket notifications, premarket approval applications, recalls and market withdrawals, GRAS self-affirmations and notifications, and product listings and establishment registrations. He represents clients before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA) and Federal Trade Commission (FTC). Karl also represents clients in State food and drug law matters on various regulatory matters including wholesaler/distributor licensing and registration. Karl currently serves as Legal Advisor to the International Veterinary Regenerative Medicine Society (IVRMS) and is a member of the National Thoroughbred Racing Association�s (NTRA) Safety and Integrity Alliance Subcommittee on Aftercare. He is the author of numerous articles and frequently presents on various FDA regulatory topics.