FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
Date: April 24-25, 2025
Duration: 2 Days
Time: Starts at 9 AM EST
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.
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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Day One (9:00 AM - 4:00PM) EST
9:00 – 11:00 AM: Lecture 1: Moving a Product out of R&D
- Issues with research grade material used for laboratory and non-clinical testing
- Optimizing manufacturing processes
- Raw material requirements and process development
- Assessing scalability of manufacturing
- Planning the CMC for a potential IND
11:00 PM – 12:30 PM: Lecture 2: CMC Requirements for an IND Study
- Essential elements of the CMC section of an IND
- Characterization of the active ingredient and finished product
- Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices
- Manufacturing facility, personnel and equipment requirements
12:30 – 1.00 PM: Break
1:00 – 2:45 PM: Lecture 3: GMPs for Phase 1 IND Products
- The scope of the FDA guidance document
- Acceptable practices and practical tips
- GMP requirements for exploratory clinical studies
- Specific requirements for drugs, biologics and combination products
- Core principles of GMP
2:45 – 3.00 PM: Break
3:00 – 4:00 PM: Lecture 4: Raw Material Management
- Planning for the early stage with an eye towards large scale manufacturing
- Vendor management
- Raw material handling issues for early stage products
- Manufacturing step development
Day Two (9:00 AM - 4:00PM) EST
9:00 – 11:00 AM: Lecture 5: Process Validation in Early Stage GMP
- Basic principles of process validation and process verification for Phase 1 GMP
- What needs to be validated and when
- Strategies for different processes
- Documentation and training expectations for Phase 1 products
11:00 AM – 12:30 PM: Lecture 6: GMPs for Early Stage Medical Devices: QSR and GMP
- Devices for pilot testing
- Design control and documentation requirements.
- Up-scaling device manufacturing
- Specific issues with IDE and non-IDE clinical studies
12:30 – 1.00 PM: Break
1:00 – 2:45 PM: Lecture 7: Clinical Trials with Early Stage Products
- IRB issues with early stage and first-in-man clinical trials
- Informed consent requirements for early stage INDs
- Investigator’s brochure
- Investigational product management: supply, shipping and accountability
2:45 – 3.00 PM: Break
3:00 – 4:00 PM: Lecture 8: Outsourcing Early Stage Manufacturing
- Logistics of using contract manufacturing organizations for early stage products
- Pilot scale manufacturing requirements
- GMP-grade and non-GMP grade manufacturing
- Benefits and challenges with using local and international vendors
Register Online (By clicking on the links below)
Prices are in US Dollars.
The registration fee includes the workshop and all related course materials.
Terms & Conditions to register for the Workshop
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this seminar, please email us at info@fdamap.com
Payment:
We accept credit card, debit card, and PayPal.
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 20 working days prior to the start date of the event will receive a refund — less a $200 administration fee per person. No cancellations will be accepted — nor refunds issued — within 20 working days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future FDA Map event and a credit note will be issued.
