EU Network Training Centre - April 2024 Newsletter
Read the online version | ISSN 2812-0809
  April 2024  

EU Network Training Centre Newsletter

Training by the Network for the Network

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This newsletter, targeting EMA and NCA staff, provides the latest news on the EU Network Training Centre, a joint initiative set up by EMA and HMA with the aim of ensuring the exchange of good scientific and regulatory practices across the EU Regulatory Network. Visit the EU NTC portal to learn more.

Highlights

Quote Welcome to the April 2024 EU NTC Newsletter. As you will see, we have refreshed the look and feel of our newsletter to make it more user-friendly, easy to navigate and appealing to you, our subscribers.

Lars Bo Nielsen and Zaide Frias,
co-chairs of EU NTC Training Steering Group

 

Picture1_a7dfKOJSFzNYzHD02iAVZ829Zqo_104179.png

Click on the image above to watch the brand-new EU NTC promotional video

Open registrations

NETWORK PORTFOLIO, SUBSTANCE MANAGEMENT

Introduction to the EU Structured Substances Database (EU-SRS) and presentation of practical use cases

EMA is facilitating a webinar on the EU Substance Registration System (EU-SRS), organised by the HMA Substance Validation Group (SVG).

Date
date 24/04/2024
Venue
venue Webinar, 10:00 – 11:30 (CEST)
Registration
Registration Link for NCAs
SeeAlso
See also Link for EMA
 
more
 
REGULATORY

Regulators Dialogue Programme: A brief insight into the tasks of a medical assessor

This is the fifth webinar in the training series developed by regulatory colleagues in the Department of Medical Assessment, Austrian Agency for Health and Food Safety (AGES).

Date
date 30/04/2024
Venue
venue Webinar, 10:30 – 12:00 (CEST)
Registration
Registration Link for NCAs
SeeAlso
See also Link for EMA
 
more
 
REGULATORY, METHODOLOGY

Introduction to the new HTA Regulation and future collaboration at the regulatory/HTA interface

New operations under the HTA Regulation will enable technical cooperation between medicines regulators and HTAs.

Date
date 02/05/2024
Venue
venue Webinar, 10:00 – 11:30 (CEST)
Registration
Registration Link for NCAs
SeeAlso
See also Link for EMA
 
more
 
ENVIRONMENTAL RISK ASSESSMENT, NON-CLINICAL

Training on the guideline on the environmental risk assessment of medicinal products for human use

This face-to-face training has been developed by the Environmental Risk Assessment drafting group in liaison with the Non-clinical Working Party (NcWP).

Date
date 23/05/2024 - 24/05/2024
Venue
venue Face-to-Face & Webinar, Day 1: 13:00 - 19:30 (CEST) and Day 2: 09:00 - 14:00 (CEST)
 
more
 
VETERINARY

Training on the guideline on quality, safety and efficacy of bacteriophages as veterinary medicines

This webinar has been developed in liaison with the CVMP Novel Therapies and Technologies Working Party (NTWP).

Date
date 30/05/2024
Venue
venue Webinar, 10:00 – 13:00 (CEST)
Registration
Registration Link for NCAs
SeeAlso
See also Link for EMA
 
more
 
BIOLOGICAL QUALITY, ATMPS

BWP-CAT training on AAV based gene therapy

This training has been developed by the Biologics Working Party (BWP) in collaboration with the Committee for Advanced Therapies (CAT).

Date
date 31/05/2024
Venue
venue Face-to-Face & Webinar, 09:00 - 16:00 (CEST)
 
more
 
QUALITY, ATMPS

Quality assessor’s experiences with the assessment of nanomedicines and technical aspects on particle size characterisation of nanomedicinal products

This webinar has been developed jointly by BfArM and the EU Commission Joint Research Centre (JRC).

Date
date 13/06/2024
Venue
venue Webinar, 10:00 – 11:30 (CEST)
Registration
Registration Link for NCAs
SeeAlso
See also Link for EMA
 
more
 
REGULATORY

Regulators Dialogue Programme: DCP - assessment step 1: tasks of the regulators

This is the sixth webinar in the training series developed by regulatory colleagues in the Department of Medical Assessment, Austrian Agency for Health and Food Safety (AGES).

Date
date 20/06/2024
Venue
venue Webinar, 10:00 – 11:30 (CEST)
Registration
Registration Link for NCAs
SeeAlso
See also Link for EMA
 
more
 

New eLearning courses

DIGITAL

Digital Academy intro module and collection on Process Mining

In this new Digital Academy 45-minute interactive e-learning module and accompanying learning resources collection, you will learn more about Process Mining.

 
more
 
PHARMACOVIGILANCE

Training for pharmacovigilance assessors on updates to the product information (following PSUSA) and overview of MedDRA terms

This training on updates to the product information (following PSUSA) and overview of MedDRA terms was organised by the PRAC secretariat and the Pharmacovigilance office at the EMA, with PRAC sponsorship. The training consists of a recording of a webinar given on 8 March 2024.
 
more
 
REGULATORY, CLINICAL

Training series on the basics of dermatology

The series has been developed in response to an identified need for training on clinical aspects of immunological diseases.

 
more
 
HAEMATOLOGY

Challenges in drug development, regulation and clinical practice in Haemophilia

The training was developed by the Haematology European Specialised Expert Community (ESEC). This is a recording of a webinar that took place on 1 March 2024, with the participation of representatives of the Haematology ESEC as well as external experts, CHMP representatives and the Haematology Working party chair.
 
more
 
VETERINARY, ANTIMICROBIAL SALES AND USE

Training module on Antimicrobials Sales and Use (ASU) reporting protocols

This is a new recording on Power BI application training for NCAs.

 
more
 
INSPECTIONS

Joint Audit Programme (JAP) and Joint Re-assessment Programme (JRP) audit training

This is a recording of a training for JAP and JRP auditors held on 5 - 6 October 2023 on the Joint Audit Programme (JAP) for EU/EEA GMP inspectorates and the Joint Re-assessment Programme for PIC/S Inspectorates.
 
more
 

Other events of interest

New lecture in series dedicated to Jordi Llinares: Gene editing and its relevance for innovative treatments

This is one of a series of lectures dedicated to Jordi Llinares and given by eminent experts on a broad variety of topics. This lecture (and other lectures is this series) are intended to bring an individual perspective by the presenters.

Date
date 18/04/2024
Venue
venue Webinar, 15:00 - 16:00 (CEST)
 
more
 

AI Masterclass on the use of Large Language Models (LLMs)

The vision on AI is for a regulatory system harnessing the capabilities of AI for personal productivity, process automation and systems efficiency, increased insights into data and strengthened decision-support for the benefit of public and animal health.

Date
date 26/04/2024
Venue
venue Webinar, 10:00 – 13:00 (CEST)
 
more
 

Regulation of faecal microbiota transplants (FMT) and FMT-derived medicinal products in the EU

The webinar is co-organised by the Borderline Classification Group of the EU Innovation Network (EU-IN BLCG) and by the Substances of Human Origin (SoHO) team of DG Sante at the European Commission.

Date
date 28/05/2024
Venue
venue Webinar, 09:00 – 12:45 (CEST)
 
more
 

EU NTC 10-year anniversary event

Join us as we celebrate a decade of building scientific and regulatory capability and capacity building through the EU Network Training Centre. In-person participation is by invitation only. Further details will be included in the May newsletter.

Date
date 30/05/2024
Venue
venue Face-to-Face, Webinar & Broadcast, 09:00 - 16:30 (CEST)
 
more
 

Accessing EU NTC training

Visit the EU NTC portal to browse the EU NTC training offers. You can follow the direct links in the portal to access the courses in the EU NTC LMS. New EU NTC LMS users can also find more information about creating an account.

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ISSN: 2812-0809 | Catalogue Number: TC-AQ-24-001-EN-Q