7-17 July 2020
LIVE Online Academy,
8 sessions delivered across 2 weeks
Regulatory, Developmental and Manufacturing Challenges for Cell & Gene Therapies
New LIVE Online Academy!
Acquire a practical understanding of the regulatory challenges, manufacturing concerns and clinical trial preparation for CGTs/ATMPs
Live Online Academies
In light of the uncertain times we’re facing at the moment, gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.
All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.
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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.
What will you learn?
Global regulatory requirements
Consider the current regulation in Europe and globally and investigate new developments. You will evaluate possible regulatory avenues for your product.
Build on your understanding of quality control for Cell and Gene Therapies, including testing, oversight of materials and release.
GMP manufacturing standards
Confirm GMP manufacturing standards for Cell and Gene Therapies and make practical preparations for inspections.
Reflect on common preservation and shipping issues for Cell and Gene Therapies and discuss using case studies.
Investigational Medicinal Product Dossier
Gain guidance on the Investigational Medicinal Product Dossier for a Cell and Gene Therapy and what should be included.
Optimise your preparations for clinical trials.
Who is this course for?
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
- Clinical development
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
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