Course description
Regulatory, Developmental and Manufacturing Challenges for CGT
The Cell and Gene Therapy (CGT) sector has experienced a number of scientific and commercial successes and is set to grow considerably over the coming years. Through ground-breaking science and innovation, the industry is providing treatments and cures for diseases that were once impossible to overcome. Although promising, due to their nature CGTs are challenging to develop, manufacture and gain regulatory approval for.
This course will provide you with a practical understanding of regulatory challenges, manufacturing concerns and clinical trial preparation for CGTs. Using case studies and relevant examples, the course will improve your understanding of the regulatory landscape and provide you with approval routes for your product. In addition, you will gain a comprehensive understanding of the principal difficulties in delivery and shipping, applying GMP in manufacturing and getting ready for clinical trial.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
This course is designed for professionals interested in the area of CGTs/ATMPs, or already working in it. The following departments may have a particular interest:
- Regulatory affairs
- Quality assurance
- Quality control
- Manufacturing
- Bioprocessing
- Clinical development
Outcome / Qualification etc.
- Consider the current regulation in Europe and globally and investigate new developments. You will evaluate possible regulatory avenues for your product.
- Reflect on common preservation and shipping issues for Cell and Gene Therapies and discuss using case studies.
- Build on your understanding of quality control for Cell and Gene Therapies, including testing, oversight of materials and release.
- Gain guidance on the Investigational Medicinal Product Dossier for a Cell and Gene Therapy and what should be included.
- Confirm GMP manufacturing standards for Cell and Gene Therapies and make practical preparations for inspections.
- Optimise your preparations for clinical trials.
Training Course Content
- Introduction to ATMPs/Cell and Gene Therapies
- Regulatory Strategies
- Insight into Global Regulatory Expectations
- Clinical Trials
- Overcoming Quality Challenges ( Simplified Introduction)
- Practical Understanding the Risk Based Approach
- The CTD Quality Aspects
- Stem Cell – The technical Challenge (Exosome Model) Animal to Phase 1
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Good practical examples with experienced course leader. The course material was excellent to use as a reference back at work