Enrol Before | 19 September to Save £400 | 19 October To Save £200
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,595 and live online is £1,395.
£1,195.00 – £1,395.00
The price is for 2-days | Register for Module 1-Free
Learn to navigate the regulatory and quality landscape for CGTs/ATMPs.
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,595 and live online is £1,395.
Cell and Gene Therapies (CGT) or ATMPs provide cutting edge treatments for diseases that were once impossible to overcome. Due to their complexity, the quality and regulatory requirements are difficult to interpret and follow. Regulatory agencies require specific quality data for clinical approval and full market approval making the role of regulatory professional a difficult one.
This training course will provide you with a complete understanding of the regulatory and quality requirements for cell and gene therapies in the EU and US. Once completed, you will know the regulatory requirements and quality data required in clinical applications and the Common Technical Document (CTD). With a complete understanding of the regulatory routes to market in the EMA and FDA, you will have the confidence to devise a regulatory strategy for your CGT product.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver both online and classroom training courses. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.
We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.
There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
* | • The training course is delivered either online or in a classroom. Please check which course format you have booked. |
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NHS Blood Transplant –
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NHS Blood Transplant –
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Takeda –
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Celonic –
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Individual Booking (verified owner) –
Very interesting course, high quality and with a very experienced trainer. I have learned a lot!
Boehringer Ingelheim (verified owner) –
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Sangamo Therapeutics France –
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MaxCyte (verified owner) –
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Micregen (verified owner) –
Andrews expertise is excellent, hes a great presenter and I have learnt more than I expected. Thank you
Universita di Trento (verified owner) –
It was a really good course.
Acorn Regulatory –
Excellent course with a small group, meaning very personalized training for individuals with different experience levels with ATMPs and regulatory affairs
Saudi Food and Drug Authority (SFDA) –
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