For modern Regenerative Medicine Therapies (RMTs) and Advanced Therapy Medicinal Products (ATMPs), the regulatory pathways and regulations continue to evolve in catch-up mode as manufacturing advances at rate much faster than the governance. This complex compliance situation is further challenged by differences between regulators and regulations. While this is an exciting time for the industry around Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps), it is difficult but critical that Quality and Production personnel understand the relevant requirements. This training course is designed to help, specifically for early-stage manufacturing for phase 1 clinical trials in the USA and Australia.
Content
This course will address FDA and TGA GMP requirements for Phase I Clinical Trials including:
- Pathway to Product Approval: USA versus Australia
- CMC – the touchpoint between product development and GMP manufacturing
- Minimum GMP Requirements for Phase I cell-based products
- Quality Assurance and Quality Control
- Sterility Assurance
- Qualification and Validation requirements
- Key differences between manufacturing allogenic and autologous products
with reference to the following regulations and guidelines:
- 21CFR part 210 / 211 (CGMPs)
- FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs
- FDA Guidelines for Human Somatic Cell and Gene Therapies
- TGA Biologicals regulations
- TGA Clinical Trial Handbook
- PIC/S Annex 2A (Manufacture of advanced therapy medicinal products for human use)
- PIC/S Annex 2B (Manufacture of biological medicinal substances and products for human use)
Participants
Personnel involved in projects, clinical trials, quality or operations for manufacturing cell-based therapies will all benefit from this training by establishing a solid understanding of the regulatory framework governing their business processes and the differences between the USA and Australia.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training is delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.
An online quiz assessment will be issued by SeerPharma on e-mail after delivery of the course is complete.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Sessions
Participants will attend both half-day sessions:
| Sessions | Dates | Times |
| Day 1 | To Be Advised | 9:00am-12:30pm |
| Day 2 | To Be Advised | 9:00am-12:30pm |
Times are based on Melbourne, Australia.
Fee and Discount
- AUD $700 (excluding GST) per participant
- A 10% discount applies for 3 or more participants from the same company
Contact us to discuss your interest in a public or private delivery of this course.
