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November 2021
Course Not Running in 2022

Acquire a practical understanding of the regulatory challenges, manufacturing concerns and clinical trial preparation for CGTs/ATMPs

Regulatory, Developmental and Manufacturing Challenges for Cell & Gene Therapies has been postpended. Please see our next course Potency & Comparability for ATMPs

Course Not Running in 2022

Please check out all upcoming courses at the link above.

Thank You!

Course Overview

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.

Live Online Academies

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.

Over 2 days students will learn through:

  • Live interactive sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

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.

Quality control

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.

Common challenges

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.

Clinical trials

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
  • Manufacturing
  • Bioprocessing
  • Clinical development

Product Development


Xintela AB

Good practical examples with experienced course leader. The course material was excellent to use as a reference back at work.

Delegates of our live online academies said...


would attend another live online academy


found the course beneficial to their day to day role


would recommend the course to others