New
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Introduction to Advanced Therapy Medicinal Products Course & Certification
Intermediate
Watch Preview
4.7
★★★★★
96% Recommended
3 hours
122 active users
3 points
Watch Preview
Your Study Basket
Introduction to Advanced Therapy Medicinal Products
| Total | |
🎁 FREE Bonus Included
eBookWorth £29— Yours FREE when you purchase today.
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
Introduction to Advanced Therapy Medicinal Products (ATMPs) provides a foundational understanding of innovative therapies based on genes, cells, and tissues. The course explains key ATMP concepts, regulatory requirements, manufacturing principles, and quality considerations essential for developing safe and effective advanced therapies.
This Introduction to ATMP Training Course covers ATMP classifications, EU regulatory framework, cell and gene therapy principles, GMP requirements, starting and ancillary materials, chain of identity, aseptic processing, quality risk management, potency, comparability, and regulatory expectations. Upon successful completion, learners gain essential knowledge of ATMP development, manufacturing, and quality practices.
Who Should Enrol?
- Pharmaceutical and biotechnology professionals
- Cell and gene therapy researchers
- Quality Assurance and Quality Control professionals
- Manufacturing and process development teams
- Regulatory affairs professionals
- Clinical research and healthcare professionals
- Anyone seeking knowledge of advanced therapy medicinal products
What you will learn
Understand the fundamentals of Advanced Therapy Medicinal Products (ATMPs), including gene therapies, cell therapies, and tissue-engineered products.
Learn ATMP classification, regulatory frameworks, GMP principles, and key quality requirements for advanced therapies.
Develop knowledge of starting materials, ancillary materials, traceability, aseptic processing, potency, and comparability concepts.
Gain understanding of risk management, regulatory expectations, and quality considerations to support safe and effective ATMP development.
Course Syllabus
- What ATMPs are and why they are different from conventional medicines
- The four classes of ATMP
- Autologous versus allogeneic products
- How ATMPs differ from conventional medicines
- The ATMP landscape: modalities and examples
- The manufacturing challenge and the road ahead
- The EU framework: Regulation (EC) No 1394/2007 and the Committee for Advanced Therapies
- EU routes to market: MA, hospital exemption and PRIME
- The US framework: PHS Act, FDA and CBER
- US human cells and tissues and 21 CFR 1271
- Expedited and access pathways
- Comparing the EU and US frameworks
- The EU Part IV GMP guidelines
- The risk-based approach to ATMP GMP
- The US GMP framework: cGMP, biologics and CGTP
- The Pharmaceutical Quality System for ATMPs
- GMP fundamentals: people, documents and data
- Comparing EU and US GMP and getting started
- Facility design and layout for ATMPs
- Cleanroom grades and classification
- Segregation, containment and GMO handling
- Closed and functionally closed systems
- Critical utilities and their control
- Environmental monitoring for ATMP campaigns
- Applying Annex 1 and the CCS to ATMPs
- Closed and functionally closed aseptic processing
- Aseptic technique and interventions
- Aseptic process simulation for ATMPs
- Sterility testing and rapid methods
- The short-shelf-life problem and release
- Starting materials: cells, tissues and vectors
- Donor eligibility and sourcing
- Raw and ancillary materials qualification
- Single-use systems and supplier qualification
- Traceability and coding
- Managing the incoming supply chain
- The manufacturing process and batch definition
- In-process control and process validation
- Quality control: identity, purity, potency and safety
- Comparability across changes
- Batch release in the EU and US
- Deviations, OOS and short-shelf-life release
- The quality system in operation
- Chain of identity and custody
- Cold chain and logistics
- Pharmacovigilance and long-term follow-up
- Preparing for EU and FDA inspection
- Preparing for EU and FDA inspection
- 📘 Bonus: Introduction to Advanced Therapy Medicinal Products eBook (Free with purchase)
Course Benefits
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay current with the EU framework for ATMPs (Regulation (EC) No 1394/2007 and the EudraLex Volume 4 Part IV GMP guidelines) and the US framework (Public Health Service Act section 351, 21 CFR Parts 210/211 and 1271, and FDA/CBER expectations), together with the application of the revised EU GMP Annex 1 to aseptic processing and sterility assurance for cell and gene therapies.
Learn from Industry Experts
This course was developed by cell- and gene-therapy and GMP specialists with practical experience of ATMP process development, aseptic manufacturing, regulatory submission and inspection across the EU and US. Each module ties the requirements to real manufacturing decisions and inspection expectations.
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
