Cell & Gene Therapy Products – CMC & Quality Requirements

Days
Hours
Minutes
Seconds
Online Live Stream

Cell & Gene Therapy Products – CMC & Quality Requirements

Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer

Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation
Fully online

All sessions of this unique course also online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

With the increasing complexity of new cell & gene therapies, as well as a rapid growth of these products in the development, unique challenges have emerged especially in the area of manufacturing and control. Leading biotech players are utilizing available regulatory pathways to accelerate the approval of ATMPs. However, the pathways to meeting CMC requirements are not as clearly defined. Novel approaches must be taken to ensure the identity, strength, quality, purity or potency of the product.

This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns.

Join us & achieve CMC readiness for your cell & gene therapy medicinal products.

meet the training leaders
Matthias Renner
Head of Section Quality of Coagulation Products and Gene Therapy Senior Scientific Assessor for quality aspects of ATMPs
Paul-Ehrlich-Institut (PEI), Germany
Dr. Robert E. Zoubek
Executive Consultant
Granzer Regulatory Consulting & Services, Germany
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Cell & Gene Therapy Products CMC & Quality Requirements online live training by Fleming_Agenda Cover
Cell & Gene Therapy Products CMC & Quality Requirements online live training by Fleming_Agenda Cover
Cell & Gene Therapy Products CMC & Quality Requirements online live training by Fleming_Agenda Cover
key training

Topics

The ATMP regulatory framework

Quality raw materials & starting materials criteria

Process development & manufacturing strategy

Process validation requirements

Method validation/qualification strategies

Release specifications for ATMPs

Analytical characterization & comparability

Data requirements for manufacture and control

Gene therapy product class specificities

Manufacturing process changes/ Change control

Benefits of attending

Testimonials

Registration

Training tickets

Delegate Fee
FROM
2396
Online Live Stream
FROM
1696

Venue

NH Danube City 

Wagramer Str. 21,
1220 Wien, Austria
Phone: +43 1 260200

NH Danube City

Contact us

Related events

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

Name
Job
Company
Bio
Name
Description