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EU Network Training Centre - April 2024 Newsletter
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
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
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).
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
23/05/2024 - 24/05/2024
venue
Face-to-Face & Webinar, Day 1: 13:00 - 19:30 (CEST) and Day 2: 09:00 - 14:00 (CEST)
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).
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.
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.
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.
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.
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.
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.
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.
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.
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