2024 QWP training for quality assessors

Topics:

• Medical devices and quality assessment: basics, integral and co-packaged devices, borderline cases, electronic/digital components and interpretation of Notified Body opinions.
• Sterilisation methods.
• GMP matters and quality assessment: GMP certificates, QP declaration and mutual recognition agreements.
• ICH M9, Biopharmaceutics classification system based biowaivers.
• Nanomedicines & liposomal formulations.

Target audience: Quality assessors (competent and advanced level) involved in the assessment of applications for human or veterinary medicinal products. 

Reimbursed seats:

There is 1 reimbursed seat available per agency. 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 proper approval from NCA management to take up this space (with the approver in cc of the email). 

3. Please set up an EMA account if you don't have one already by following the link below. An EMA account is needed to receive the reimbursed invitation: https://register.ema.europa.eu/identityiq/home.html 

4. When the reimbursed invitation has been received, book travel and hotel via the EMA travel agent by 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.

Here are 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 to register for the reimbursed session: 15 August 2024

Link for NCAs (reimbursed)

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. 

Deadline to register for the non-reimbursed session: 28 August 2024

Link for NCAs (non-reimbursed)

Link for EMA (non-reimbursed)

Webinar participation:

This session can also be followed via webinar organised by EMA. Participants registered to the webinar in the LMS will receive the connection information in their inbox closer to the date of the webinar. 

Deadline to register for the webinar: 13 September 2024

Link for NCAs (webinar)

Link for EMA (webinar)

For more information on the EU NTC, please see EU NTC portal