ATMPs Quality by Design From Bench to Clinic

Introduction to Advanced Therapeutic Medicinal Products and Regulatory Requirements

Advanced Therapeutic Medicinal Products (ATMP)s are medicines are based on genes, tissues or cells and represent a growing number of therapeutics entering clinical development and Market Authorisation Application (MAA).  

 

Due to their cutting-edge status, ATMPs sit within an evolving area of legislation which manufacturers need to keep abreast of.  

 

This one-day training course is designed to introduce you and build your confidence on ATMPs, allowing you to become familiar with their categories as well as the key regulatory requirements for ATMP development. To provide a full picture, the course will also consider important factors within the process development journey including Good Manufacturing Practices (GMP), the preparation and submission of Investigative Medicinal Product Dossiers (IMPD) and Investigator Brochures (IB) as well as quality, potency and stability assessment of your product. 

 

Interested in ATMPs training for your team? Contact us today. 

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Duration
1 day
CPD Hours
7 hrs
Locations
  • Online

Who Should Attend

The course is suitable for any research and development staff working within ATMP process development. This would include, but not be limited to, persons with responsibility for: 

  • QPs looking to development their knowledge in AMTPs 
  • Trainee QPs keen to learn more about  R&D development and the technical transfer to GMP production of ATMPs 
  • Quality aspects of ATMP development and manufacturing e.g Quality Assurance and Quality Control persons 
  • Manufacturing of ATMPS, e.g. GMP managers and GMP production persons 
  • Analytical and microbiological testing of ATMPs (QC laboratory persons) 
  • Process engineering developments for ATMPs 

 

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Key topics

 This course covers the following topics:

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    Introduction to ATMPs and legal definition 

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    Borderline products – discussion and evaluation 

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    Relevant legislation and guidance - including ICH guidelines and FDA compliance  

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    Research and development 

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    Plasmids, vectors and process development 

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    Analytical method and microbiologic assay development 

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    Good manufacturing and distribution practices of ATMPs 

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    Facility design – Annex I etc considerations 

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    Moving your product from manufacturing to clinic 

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    Preparation of regulatory documentation 

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    Interacting and working with local and international competent authorities 

Learning Outcomes

By completing this training you will understand:  

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    The basics of ATMPs and their categories 

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    The key factors to consider with your process development from bench to clinic 

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    GMP preparation and submission of IMPD 

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    Investigator Brochures,, and the quality, potency and stability assessments of your product 

Meet your expert tutors

Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Rebecca Rutter (1)

Rebecca Rutter

Rebecca is a Qualified Person and Responsible Person with expertise in biotechnology products and the provision of support for Advanced Therapy Medicinal Products (ATMPs). She has held director positions at several prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.
Frequently asked questions

If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.

Yes, the ATMP Quality by Design course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details. 

Places will be available for you to book unless it states ‘Full’ next to your chosen ATMP Quality by Design course date. When this occurs, we operate a waiting list service. 

Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems. 

You will need to first register yourself on our booking system by selecting the ATMP Quality by Design course date that you wish to book your colleagues onto, then:

  • Add the number of people you wish to book onto the course
  • Register yourself as the booker and complete the fields accordingly
  • Add the details of those you wish to book for
  • Complete your order. 

You will receive an automated email confirming your booking details for the ATMP Quality by Design course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included.

Usually, this 1-day ATMP Quality by Design course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000.

Our online ATMP Quality by Design course begins at 09:00am, although we request that you login at 08:30am to ensure any technical glitches can be resolved before the start time. Please review your course confirmation email to double check the exact start time of your specific course.

 

Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system. 

Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. 

Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address. 

Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email. 

As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
Please see our 'minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test. 

Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.

All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Insightful and Resourceful

Insightful and full of information and resources. Content and delivery both were appropriate to me as a QP
Prerna Suri
MSD UK Ltd - Qualified Person

Book Your Place

ATMPs Quality by Design From Bench to Clinic
15 Jan 2025
-
Online
£ excl VAT
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Bespoke Training

We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Why choose RSSL?

As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community