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Starting 23-24 November 2021
2 Day LIVE Online Course 2-5pm GMT
Starting 23-24 November 2021

2 Day LIVE Online Course 2-5pm GMT

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

Course Overview

This course will provide you with a practical understanding of regulatory challenges, manufacturing concerns ATMPs. 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 lifesciences-training@informa.com.

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.

Clinical trials

Optimise your preparations for clinical trials.

Who is this course for?

This course is designed for professionals interested in the area of ATMPs, or already working in it. The following departments may have a particular interest:

  • Regulatory affairs
  • Quality assurance
  • Quality control
  • Manufacturing
  • Bioprocessing
  • Clinical development

CPD Certified

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.