BWP-CAT training on AAV based gene therapy
date: 31/05/2024
venue: Face-to-Face & Webinar, 09:00 - 16:00 (CEST)
Topics: The training will provide an introduction to AAV Gene therapy medicinal products for biologics assessors from the quality perspective and provide examples and case studies relevant to assessment of these types of products.
The training will cover: Introduction to AAV gene therapy; Overview of Guidelines and Ph. Eur. monographs relevant for AAVs; CQAs, characterisation, and release tests; Viral risk assessment of AAVs; New active substance status and orphan similarity issues for AAVs; Exemption from EU release testing on import; Case studies
Target audience: This training is aimed at biological quality assessors currently involved in the assessment of AAV-based gene therapies, and biological quality assessors wanting to increase their knowledge to allow them to expand into assessment of AAV-based gene therapies.
Reimbursement: There is 1 reimbursed seat available per NCA for a Biological Quality Assessor currently involved in the assessment of AAV-based gene therapies. To take up the reimbursed place for your NCA:
1. Register your participation to the reimbursed session in the EU NTC LMS.
2. Send an email to the EU NTC core team to confirm that you have the approval from your NCA's management to take up this space (with the approver in cc of the email).
3. After receiving the reimbursed invitation, book travel and hotel via the EMA travel agent using the online booking tool (Cytric). The link will be included in the invitation you receive from EMA.
Important note: In accordance with the EMA reimbursement rules, in case colleagues make travel bookings themselves, these cannot be reimbursed. Persons making their own hotel bookings (and in receipt of a reimbursed invitation) can retrospectively apply for an accommodation allowance of 100 EUR per night.
4. Please set up an EMA account if you do not have one already by following the link below. Please note that an EMA account is needed to receive the reimbursed invitation: https://register.ema.europa.eu/identityiq/home.html
Here are the step-by-step instructions on how to set up an EMA account: https://register.ema.europa.eu/identityiq/help/selfregister.html
5. Read reimbursement rules: Rules for reimbursement of expenses for delegates attending meetings
Deadline for registration: 30 April 2024 (reimbursed session)
Non-reimbursed seats: There are a limited number of non-reimbursed seats available for this course. Please note that no additional MMS-e invitation will be sent to the non-reimbursed participants.
Link for NCAs (non-reimbursed) Link for EMA (non-reimbursed)
Deadline for registration: 10 May 2024 (non-reimbursed session)
Webinar participation: This session can also be followed via webinar organised by EMA. Participants registered to the webinar will receive the connection information in their inbox closer to the date of the webinar.
Link for NCAs (webinar) Link for EMA (webinar)
Deadline for registration: 24 May 2024 (webinar session)
For more information on the EU NTC, please see EU NTC portal