FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
Date: November 21-22, 2019

Location: Washington DC

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 a 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. Key templates will be provided. Past attendees have a 100% success rate in using the training to file INDs with the FDA and initiate clinical trials.

Detailed Agenda
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Who will benefit:​​​

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

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
Agenda of the seminar:
Moving a Product out of R&D
CMC Requirements for an IND Study
GMPs for Phase 1 IND products
Raw Material Management
Process Validation in Early Stage GMP
GMPs for Early Stage Medical Devices: QSR and GMP
Clinical Trials with Early Stage Products
Outsourcing Early Stage Manufacturing

Speaker: Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and biotech products. He has been involved in more than 100 multi-national clinical trials, has made hundreds of submissions to the US FDA, EMA, and regulators in more than 40 countries. He has arranged a number of meetings with the US FDA. Read More

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