General training session on IRIS Network Portal and SharePoint (08/05/2025)

This webinar will provide Network stakeholders with knowledge of key IRIS functionalities for regulatory procedure management.

It’s not over till it’s over: DCP - Assessment Step 2 and Article 29(1) CMD(h) - Referral (15/05/2025)

This webinar, organised by AGES (Austria), aims to take participants through the second assessment stage of the Decentralised Procedure (DCP) to give them a basic understanding of the steps leading to the finalisation of the procedure and the further discussion in the CMD(h), if applicable.

Environmental Risk Assessment (ERA) assessors meeting 2025 (15/05/2025)

This face-to-face training will take place in Vienna, Austria. Its purpose is to discuss experiences with the newly published ERA guideline and to provide further training input on the topics of the new guideline.

E-learning for European Medicines Regulatory Network (EMRN) topic experts (16/04/2025)

This module aims to provide subject matter experts with a high-level overview of e-learning development and instructional design processes, to support them in their roles as topic experts.

Viral safety training course for assessors (16/04/2025)

The goal of the course is to improve knowledge of the participants related to the way the viral safety aspects of a CMC dossier/Module 3 should be evaluated.

Maximum likelihood estimation basics: A PK modelling perspective (16/04/2025)

This is a recording of a webinar held on 20 November 2024 and organised by the Methodology Working Party and Modelling and Simulation Operational Expert Group. It forms part of the Biostatistics and Clinical Trial Methodology curriculum.

Data Science: Omics survey (16/04/2025)

A new module on Omics is currently being developed as part of the Data Science curriculum. In this context, the module coordinators are looking for assessors' feedback to inform the content of the module via a survey.

Welcome (19/03/2025)

We are pleased to inform you that EMA intends to launch an open call for tender for the provision of services to design, develop and deliver e-learning courses in the field of pharmaceutical quality assessment, clinical and non-clinical assessment, specifically targeted to strengthen the scientific and regulatory capacity of junior assessors on the African continent.

Virtual walk-in clinics for IRIS Network users on post-authorisation regulatory procedure management in IRIS (07/01/2025)

These walk-in clinics are being organised by the Regulatory Procedure Management team for Product Lifecycle Management (PLM) in IRIS to allow Network users, who are using IRIS for product lifecycle management procedures after the transition taking place in January 2025, to ask urgent questions.

Joint EMA/EC webinar on the European Regulation on substances of human origin, clinical safety, practice and use of transfusions (19/03/2025)

This is a recording of the 3rd webinar of the Haematology curriculum training and focusing on European Regulation on substances of human origin (SoHO), clinical safety, practice and use of transfusions.

Refresher training for PSUSAs and the process updates related to the removal of section 6 (Other considerations) (19/03/2025)

This is a recording of a webinar held on 3 February 2025 aimed at strengthening the competency of pharmacovigilance assessors to manage and assess PSURs.

Training for CAP samplers on the label check exercise and anti-tampering device verification (19/03/2025)

This is a recording of a course aimed at providing guidance and best practices to the EU samplers when performing the label check exercise and anti-tampering device verification in the context of the CAP Sampling and Testing Programme.

European Shortages Monitoring Platform (ESMP) training session for National Competent Authorities (NCAs) (19/03/2025)

This is a recording of a webinar held on 30 January 2025 aimed at providing Network stakeholders with an overview of their role in the ESMP ecosystem and details regarding how to gain and manage access to the platform.

ICH S1 B(R1) Testing for carcinogenicity: OEG Perspective (19/03/2025)

This is a recording of a presentation which provided a high-level overview of the assessment of the integrative weight of evidence approach to assess human carcinogenic potential of pharmaceuticals, as described in ICH S1 B(R1).

Q&A session for Network stakeholders regarding Regulation (EU) 2024/568 (19/03/2025)

This is a recording of a Q&A clinic held on 14 February 2025 to address urgent questions from Network stakeholders regarding Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency.

European Shortages Monitoring Platform (ESMP) API workshop (19/03/2025)

This is a recording of an EMA-hosted workshop on 17 February 2025 for NCAs focusing on the ESMP’s Application Programming Interface (API).

Nitrosamines safety risk assessment (19/03/2025)

This is a recording of a presentation providing a brief overview of the nitrosamine impurities safety issue to date and the current regulatory guidance and tools used to assess nitrosamine impurities and derive an acceptable intake limit.

Weight of evidence for enhanced pre- and postnatal study ePPND study waivers (19/03/2025)

This is a recording of a presentation which discussed developmental and reproductive toxicity (DART) animal studies in the context of the ICH S6 Guideline for Preclinical safety evaluation of biotechnology.

AAV GT host genome integrations compared to environmental, lifestyle and background genotoxicities (19/03/2025)

This is a recording of a course which covers the calculated absolute liver integration burdens after administration of two approved haemophilia AAV gene therapy products as well as absolute burdens of environmental, lifestyle and background genotoxicities.

Error-corrected Next Generation Sequencing (ecNGS) – Future method to measure mutation frequency and detect mutations in vivo (19/03/2025)

This is a recording of a presentation that provides an overview of currently used assays for in vivo mutagenicity testing, including TGR and Pig-a.

Non-interventional and external control arm studies: RWE reflection paper and experience from use cases - Real World Academy session 5 (19/03/2025)

This is a recording of a webinar held on 7 March 2025 focused on the reflection paper on use of real-world data in non-interventional studies to generate real-world evidence and use cases where external control arm was proposed.

Regulatory requirements for the clinical development of medicinal products for the treatment or prevention of diabetes mellitus (19/03/2025)

This is a recording of a webinar held on 5 March 2025. It covers the presentation of the guideline and where it can be found on the EMA website as well as developing and licensing medicinal products (except insulin products) for the treatment of type 2 diabetes mellitus.

Quality management for the national collection of antimicrobial sales and use data in animals – ISO standards and best-practices examples (19/03/2025)

This is a recording of a webinar held on 15 November 2024 aiming at enabling participants to apply the relevant ISO standards in the development of a data quality management plan for the national collection of antimicrobial sales and use data.

Introduction to the estimands framework from ICH E9 (R1) (19/03/2025)

This is recording of a webinar which took place on 27 February 2025 aiming at increasing the understanding of the estimand framework.

Welcome (12/02/2025)

Welcome to the February 2025 newsletter!

Q&A session for Network stakeholders regarding Regulation (EU) 2024/568 (14/02/2025)

This is a Q/A clinic to address urgent questions from Network stakeholders regarding Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency.

Q&A session on Power BI App IRIS NCA Dashboard (19/02/2025)

This is a short Q&A clinic to address specific questions from Network users who are using the IRIS NCA Dashboard.

Non-interventional and external control arm studies: RWE reflection paper and experience from use cases - Real World Academy session 5 (07/03/2025)

The 5th session of the Real World Academy focuses on the reflection paper on use of real-world data in non-interventional studies to generate real-world evidence and use cases where external control arm was proposed.

Training on the ICH M12 guideline on drug interaction studies (in vivo aspects) (12/02/2025)

This is a recording of a webinar organised by the Methodology Working Party and held on 26 November 2024 (in vivo aspects)

Walk-in Clinic on post-authorisation regulatory procedure management in IRIS (12/02/2025)

This is a recording of a webinar organised by the IRIS team and held on 2 December 2024.

Risk Minimisation Measures (RMMs): management, assessment and implementation (12/02/2025)

This is a recording of a webinar held on 4 December 2024 and organised by the PRAC secretariat and the Pharmacovigilance office at the EMA, with PRAC sponsorship.

Training session on the Power BI App IRIS NCA Dashboard (12/02/2025)

This a recording of a training session held on 6 December 2024 and aimed at providing NCAs with the necessary knowledge to be ready for the use of the IRIS NCA Dashboard in Power BI App.

Classification and data requirements for applications for VMPs intended for limited markets and eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (12/02/2025)

This is a recording of a training course held on 10 - 11 December 2024 and organised by the CVMP Limited Markets Oversight Group in collaboration with the Immunological Working Party, Safety Working Party and Efficacy Working Party.

Webinar on NCAs read-only access to Product Management Service (PMS) Application Programming Interface (API) (12/02/2025)

This is a recording of a webinar held on 15 January 2025, aimed at providing an overview of the PMS API, and showcasing the access and data read through the API.

Acne vulgaris - an overview (12/02/2025)

This training module has been developed by Dr Anna Cunney, Seconded National Expert at EMA and clinical specialist for immune and inflammatory diseases.

EMA Veterinary Innovation Day (13/03/2025)

EMA will be hosting the second edition of the Innovation Day for veterinary medicines on 13 – 14 March 2025. The hybrid event will include sessions on the EU legislative framework for veterinary medicinal products and the Agency’s support to innovation and veterinary medicines.

Welcome (15/01/2025)

Welcome to the first newsletter of 2025!

Introduction to the estimand framework and application to specific indications (22/01/2025)

This webinar has been organised by EMA in collaboration with BfArM and the EMA Methodology Working Party. Please note that it will be repeated on the 17 February 2025.

Viral safety training series for quality assessors (28/01/2025)

Viral safety assessors from ANSM, AGES, BfArM and PEI in liaison with the Biologics Working Party (BWP) have developed a viral safety training course for quality assessors. The training course is being held as a series of 6 webinars taking place in the period January – March 2025.

European Shortages Monitoring Platform (ESMP) training session for National Competent Authorities (NCAs) (30/01/2025)

This webinar will provide Network stakeholders with an overview of their role in the ESMP ecosystem and details regarding how to gain and manage access to the platform.

Refresher training for PSUSAs and the process updates related to the removal of section 6 (Other considerations) (03/02/2025)

This training has been developed by the PRAC secretariat and the Pharmacovigilance office at the EMA, with PRAC sponsorship.

Training session on the Power BI App IRIS NCA Dashboard (06/02/2025)

The goal of the module is to provide NCAs (specific Committees) with the necessary knowledge to be ready for the use of the Power BI App IRIS NCA Dashboard.

EU NTC LMS guide (20/01/2025)

In this concise and interactive e-learning, the users of EU NTC leaning platform will master the usage of the system

Training series on anti-infective agents, including antibacterial, anti-tuberculosis, antifungal, and antiviral agents (20/01/2025)

The CHMP Infectious Disease Working Party (IDWP) has organised a series of 6 webinars on anti-infective agents, including antibacterial, anti-tuberculosis, antifungal, and antiviral agents. The recordings of the first 5 webinars are now available

Challenges in drug development, regulation and clinical practice in bladder cancer (20/01/2025)

This is a recording of the 7th webinar of the Oncology curriculum training focusing on bladder cancer.

CHMP AR/Overview template training (20/01/2025)

This module gives an introduction to the new CHMP AR/Overview template, scheduled for release in January 2025.

Information session on FHIR for PLM portal web-based electronic application form (eAF) for NCAs (20/01/2025)

This is a recording of a webinar organised by the EMA Digital Business Transformation Task Force and held on 3 December 2024.

PIC/S training on ICH Q9(R1) - Quality Risk Management (QRM) (28/01/2025)

This 2-day training event is jointly organised by the PIC/S QRM Expert Circle and the European Medicines Agency. It will take place at the EMA premises in Amsterdam (with possibility of remote attendance for plenary sessions)

Clinical Trials Information System (CTIS): Walk-in clinic - January 2025 (29/01/2025)

This walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical information about the Clinical Trials Information System by asking questions to CTIS experts in real time.

EU NTC Welcome - December 2024 (17/12/2024)

Welcome to the December 2024 EU NTC newsletter!

Webinar on NCAs read-only access to Product Management Service (PMS) Application Programming Interface (API) (15/01/2025)

The event is organised by the Product Management Service (PMS) team in the EMA Information Division. It focuses on the PMS API access for NCAs managing human-only medicinal products.

Data Protection Impact Assessments and Artificial Intelligence (17/12/2024)

Discover when a DPIA is essential for AI applications, how to uphold data protection principles, and ensure robust security.

Training sessions given during visit of delegation of African Medicines Regulatory Harmonisation (AMRH) Evaluation of Medicinal Products Technical Committee (EMP-TC) (17/12/2024)

The listed training offers were recorded during a visit of the African Medicines Regulatory Harmonisation (AMRH) Evaluation of Medicinal Products Technical Committee (EMP-TC) to EMA on 24 – 27 June 2024. The event focused on various regulatory topics on human medicines such as quality, clinical and non-clinical assessments, benefit/risk assessments, and vaccines assessments.

Pharmacoepidemiology and Real-World Evidence Curriculum - Module 3: Study protocol and reporting (17/12/2024)

This is the third module of the Pharmacoepidemiology and Real-World Evidence Curriculum. The curriculum aims to provide participants with a good understanding of the pharmacoepidemiological and real-world evidence concepts and methods to develop, analyse and critically review protocols and reports of non-interventional studies.

Pharmacoepidemiology and Real-World Evidence Curriculum - Module 4: Statistical methods applied to RWE (17/12/2024)

This is the fourth module of the Pharmacoepidemiology and Real-World Evidence Curriculum. The curriculum aims to provide participants with a good understanding of the pharmacoepidemiological and real-world evidence concepts and methods to develop, analyse and critically review protocols and reports of non-interventional studies.

Veterinary aspects of antimicrobial resistance and the One Health Approach (17/12/2024)

This is a recording of an Instrument for Pre-accession Assistance (IPA) training on veterinary aspects of AMR and the One Health approach, which took place on 21 and 22 October 2024

QWP training for quality assessors 2024 (17/12/2024)

This training consists of recordings of presentations given during the QWP training for quality assessors 2024 (medium and advanced level) on 2 – 4 October 2024.

Challenges in drug development, regulation and clinical practice in breast cancer (17/12/2024)

This is a recording of the 6th webinar of the Oncology curriculum training, which took place on 27 September 2024. The training was designed by the Oncology European Specialised Expert Community (ESEC) and included representatives of the SAG Oncology experts as well as external experts, CHMP representatives and the Oncology Working Party chair.

Union Product Database (UPD) basic functionalities - Refresher webinar for EU network (17/12/2024)

This is a recording of a webinar organised by the EMA Veterinary Division which took place on 7 November 2024.

DARWIN EU® Training series: DARWIN EU® Autumn School (17/12/2024)

This is a recording of the DARWIN EU Autumn school which took place on 4 and 5 November 2024. It is the second part of the DARWIN EU training series and follows the Spring school conducted in June.

Training on web-based electronic Application form (eAF): human variations for NCAs (17/12/2024)

This is a recording of a webinar organised by EMA's Digital Business Transformation Task Force which took place on 7 November 2024

Risk Management Plans (RMPs): procedure management and assessment (17/12/2024)

This is a recording of a webinar held on 12 September 2024. The training was developed by the PRAC secretariat and the Pharmacovigilance office at the EMA, with PRAC sponsorship.

Training series on post-authorisation regulatory procedure management in IRIS (17/12/2024)

This series, organised by the EMA Regulatory Procedure Management for Product Lifecycle Management (PLM) team, aimed at providing Network stakeholders with the necessary knowledge to be ready for the transition of post-authorisation regulatory procedure management to IRIS.

New lecture in series dedicated to Jordi Llinares: State of the art and the perspectives of brain-computer interfaces (09/01/2025)

This session on the state of the art and the perspectives of brain-computer interfaces forms part of a series of lectures dedicated to Jordi Llinares, given by eminent experts on a broad variety of topics. You can obtain the connection link through your Training Champion.

Highlights (11/11/2024)

We are pleased to inform you of the launch of the new Oncology curriculum in the EU NTC catalogue. It encompasses all our Oncology training courses and is divided into a general Oncology sub-curriculum and a disease specific sub-curriculum. We hope you find them interesting and easy to navigate.

Oncology curriculum (18/11/2024)

The curriculum includes disease specific training which aims at obtaining knowledge on the challenges in the clinical development, regulation and clinical practice in specific diseases.

Maximum likelihood estimation basics: A PK modelling perspective (20/11/2024)

This webinar, which forms part of the Biostatistics and Clinical Trial Methodology Curriculum, is being organised by the Methodology Working Party, Modelling and Simulation Operational Expert Group.

Training on the ICH M12 guideline on drug interaction studies (21/11/2024)

This webinar is being organised by the Methodology Working Party.

Information session on FHIR for PLM portal web-based electronic application form (eAF) for NCA (03/12/2024)

This webinar is being organised by the EMA Digital Business Transformation Task Force.

Challenges in drug development, regulation and clinical practice in bladder cancer (06/12/2024)

This is the 7th webinar of the Oncology curriculum training, which has been designed by the Oncology European Specialised Expert Community (ESEC) and includes representatives of the SAG Oncology experts as well as external experts, CHMP representatives and the Oncology Working Party chair.

Classification and data requirements for applications for VMPs intended for limited markets and eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (10/12/2024)

Training for Veterinary Safety and efficacy assessors organised by the CVMP Limited Markets Oversight Group in collaboration with the Immunological Working Party, Safety Working Party and Efficacy Working Party.

Prompt Engineering - Digital Academy (17/11/2024)

Learn how to effectively and safely guide language models to deliver precise and reliable results in this new Digital Academy module.

Collaborating Digitally - Digital Academy (17/11/2024)

Explore a curated collection of resources on the most popular collaboration tools, including Microsoft Teams, SharePoint, and Webex, to enhance your digital teamwork.

Joint HTAb-regulatory workshop: understanding key evidence challenges, managing uncertainties and exploring potential solutions (18/11/2024)

This is a recording of a Joint HTAb-regulatory workshop which was organised by the EMA Scientific Evidence Generation Department and took place on 8 July 2024. This forms part of a series of webinars on the regulatory/HTA interface.

Implementation of the annex 2 of the guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water – technical aspects (18/11/2024)

This is a recording of a webinar which took place on 24 September 2024. The training was developed by the ANSM member of the Quality Working Party (QWP), in liaison with the QWP. The training forms part of the Quality curriculum.

RWD in support of regulatory work in paediatrics – example of the RWD extrapolation framework with a pilot study in dermatomyositis and polymyositis (18/11/2024)

This is a recording of a webinar session which took place on 4 October 2024. The training was developed by the EMA Data Analytics and Methods task Force, Real-World Evidence Workstream in liaison with the EMA Data Analytics and Methods task Force, Healthcare Data.

Problem of diversity in clinical trials and biomedical research (18/11/2024)

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.

IQ MPS Module 1: Introduction to complex in vitro models and microphysiological systems (18/11/2024)

This course has been developed by IQ Microphysiological Systems, a collaboration of pharmaceutical and biotechnology companies within the International Consortium for Innovation and Quality in Pharmaceutical Development to provide a venue for appropriate cross-pharma collaboration and data sharing to facilitate industry implementation and qualification of microphysiological models.

Training on H&V NCAs read-only access to Product Management Service (PMS) Application Programming Interface (API) (18/11/2024)

This is a recording of a webinar developed by the EMA Information Division which took place on 2 October 2024.

Training session on IRIS Network Portal and SharePoint use for post-authorisation regulatory procedure management (18/11/2024)

This is a recording of a webinar organised by the EMA Regulatory Procedure Management for Product Lifecycle Management (PLM) team which took place on 24 October 2024.

Microsoft Teams for NCA users (18/11/2024)

As part of EMA’s new working party model, EMA has introduced Microsoft Teams as a collaborative platform for the working parties’ meetings. This training provides practical support for common challenges, including logging into MS Teams as an external user, joining meetings from the Teams calendar, and general tips for effective collaboration using MS Teams features.

Advancing Regulatory Science Research (18/11/2024)

The event aims to stimulate interactions and collaborations to advance regulatory science research addressing key regulatory science needs. The event will combine presentations and moderated panel discussions. Virtual participation is open to all stakeholders.

Conversations on cancer – Paediatric Cancers: Navigating the Challenges Together (19/11/2024)

EMA in conjunction with FDA Oncology Center of Excellence (OCE) presents a one-hour Conversations on Cancer public panel discussion on November 19, 2024 to foster a better understanding of how decisions made by patients and their parents impact their day-to-day lives and how regulators approach difficult regulatory decisions.

Fifth HMA-EMA Big Data multi-stakeholder forum 2024 (28/11/2024)

The upcoming forum will share and discuss progress on big data and evidence generation, as well as the use and exchange of medicines data across the EU network. These discussions will inform the update of the HMA-EMA Big Data Steering Group workplan, strengthening collaboration with partners and stakeholders on the delivery of data activities included in the Network strategy.

2024 EDQM virtual training programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure (02/12/2024)

This training programme is offered by the European Directorate for the Quality of Medicines and Healthcare (EDQM).

Training series on post-authorisation regulatory procedure management in IRIS (24/10/2024)

The events are organised by the Regulatory Procedure Management for Product Lifecycle Management (PLM) team.

DARWIN EU Autumn School: Population-level disease epidemiology and patient-level characterisation (04/11/2024)

This is the second webinar in a series to increase the understanding of different types of analyses conducted through the DARWIN EU® Network.

Regulators Dialogues Programme: The clock off period from the case manager’s perspective (07/11/2024)

This webinar organised by AGES, Austria provides beginner regulatory staff with an overview of managing the clock off period, including how to handle draft responses as RMS and the management of procedure re-start.

Perseverance and Teamwork: The Key to Achieving Collective Success Through Knowledge Sharing in Science (22/10/2024)

This is a recording of a lecture given on 2 July 2024 as the first in a planned series of lectures promoting knowledge management.

Introduction of the vaccine antigen master file (VAMF) – scientific (technical) data requirements and procedural guidance for the certification process (22/10/2024)

This is a recording of a webinar which was organised by the Immunologicals Working Party (IWP) in close collaboration with PEI (DE) & IWP secretariat and which took place on 14 September 2023.

Introduction to the guideline on plasmid DNA vaccines for veterinary use (22/10/2024)

This Is a recording of a webinar organised by the Immunologicals Working Party (IWP) in close collaboration with the Health Products Regulatory Authority (HPRA, Ireland), the Paul-Ehrlich-Institut (PEI, Germany) and the IWP secretariat, and held on 25 June 2024.

Data reliability - DARWIN EU - From onboarding of data partners to study planning (22/10/2024)

This is a recording of a training webinar held on 9 September 2024 and developed by the EMA Data Analytics and Methods task Force, Real-World Evidence Workstream in liaison with EMA Data Analytics and Methods task Force, Healthcare Data.

EU Risk Management Plans (22/10/2024)

This is a recording of a webinar which was given on 29 April 2024, to African assessors in the context of the African Medicines Agency (AMA) collaboration project.

Second AI Masterclass - Hands on with the guiding principles on the use of LLMs (22/10/2024)

This second AI masterclass provides regulatory network staff with high-level recommendations and principles for the safe, responsible, and effective use of LLMs in regulatory science and activities. The session also features several use cases.

Good Manufacturing Practice (GMP) (22/10/2024)

A series of sessions given during the visit of the African Medicines Regulatory Harmonisation Good Manufacturing Practices Technical Committee to EMA in June 2024, to share knowledge and provide insights into EMA’s regulatory procedures and processes in the area of GMP.

Qualification of Non-Clinical and New Approach Methodologies – Experience from ICH S5(R3) (22/10/2024)

The training consists of a recording of a webinar given on 2 May 2024, to the Non-clinical and New Approach Methodologies European Specialised Expert Community (NC NAM ESEC). The training was developed by the EMA Translational Sciences Office.

New module in training series on the basics of dermatology: Ultraviolet radiation and human health (22/10/2024)

This is the fifth module in the Training Series on the Basics of Dermatology to increase the understanding of non-clinicians in the EU regulatory network in the area of dermatology, to apply this knowledge in the review of clinical sections of dossiers for protocol assistance, new medicines applications and clinical trial applications in this field.

Product Management Service (PMS) data mapping support for National Competent Authorities (NCAs) (22/10/2024)

This is a recording of a webinar developed by the EMA Information Division which took place on 19 September 2024.

POSTPONED - Regulators Dialogues Programme: DCP - Assessment Step 2 and Article 29(1) CMD(h)-Referral (22/10/2024)

This webinar has been postponed (date TBD). Colleagues who already registered for the webinar will be placed on a waitlist for automatic enrolment for the webinar once it has been re-scheduled and will receive a registration notification via e-mail.

HMA-EMA multi-stakeholder workshop on Artificial Intelligence (05/11/2024)

The workshop will feature keynote speakers providing updates on the latest in AI developments, and policy and legislative environment. There will be an opportunity to discuss next steps related to the AI reflection paper. Further discussions will cover AI use cases in the medicine lifecycle as well as the progress and possible updates to the HMA-EMA multi-annual AI workplan.

Reflection paper on the use of AI in the medicinal product lifecycle (01/10/2024)

Following a public consultation, the reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle has been published. It provides considerations on the use of AI in the lifecycle of medicinal products and describes the current experience of the EU medicines regulators while scientific knowledge on AI is fast evolving.

Reflection paper on establishing efficacy based on single arm trials submitted as pivotal evidence in a marketing authorisation application (08/10/2024)

This reflection paper outlines perspectives on single arm trials that are submitted as pivotal evidence for establishing efficacy in marketing authorisation applications.

September spotlight: elevate your data skills (16/09/2024)

This September we have a rich selection of data-focused training for you alongside our usual regulatory and scientific offerings. Our latest Digital Academy content helps you enhance your data literacy and data protection skills. Ready to dive deeper? Explore the first modules in the new Data Science curriculum or learn more about Real-World data.

Webinar on Product Management Service (PMS) data mapping support for National Competent Authorities (NCAs) (19/09/2024)

In this webinar we will explain how EMA will support NCAs in mapping their NAPs data in their own systems. In particular, the session will present the NCA data mapping template and provide detailed instructions to NCAs on how to populate this template effectively.

Challenges in drug development, regulation and clinical practice in breast cancer (27/09/2024)

This is the 6th webinar of the Oncology curriculum training, which has been designed by the Oncology European Specialised Expert Community (ESEC). It includes representatives of the SAG Oncology experts as well as external experts, CHMP representatives and the Oncology Working Party chair.

RWD in support of regulatory work in paediatrics – example of the RWD extrapolation framework with a pilot study in dermatomyositis and polymyositis - Real World Academy session 4 (04/10/2024)

This 4th session of the Real World Academy focuses on the use of RWD to inform and support regulatory work in paediatrics.

Digital Academy intro modules and collections on Data Literacy and Data Protection (16/09/2024)

Increase your data literacy and data protection skills with the new Digital Academy interactive e-learning modules and accompanying learning resource collections

First modules of the Data Science curriculum now available (16/09/2024)

The Data Science curriculum is a series of trainings on data science that have been specifically designed for the European Medicines Regulatory Network (EMRN) to enhance knowledge and develop skills in this field.

Assessors training on the environmental risk assessment for human medicinal products (16/09/2024)

This e-learning is based on the recording of a face-to-face training developed by the Environmental Risk Assessment Drafting Group, in liaison with the Non-Clinical Working Party (23 – 24 May 2024). This training forms part of the non-clinical curriculum.

Darwin EU Spring Session: Analyses conducted through the DARWIN EU Network (16/09/2024)

This is a recording of the first webinar series organised to increase the understanding of different types of analyses conducted through the DARWIN EU® Network. Registration for the Autumn Session is now open (see under 'open registrations')

Joint HMA/EMA Big Data Steering Group Workshop on RWE methods: Harnessing Real-World Data for Regulatory Use (13/09/2024)

The training consists of a recording of a one-day hybrid Big Data Steering Group (BDSG) workshop held on 14 June 2024. The programme was developed by the EMA Data Analytics and Methods Task Force, Real-World Evidence Workstream.

An Introduction to Estimands (16/09/2024)

The training consists of a recording of a webinar given on 8 September 2023. The training was developed by the EMA Data Analytics and Methods Task Force, Real-World Evidence Workstream.

Challenges and future role of artificial intelligence and machine learning in pharmacovigilance (16/09/2024)

This is a recording of a webinar held on 26 July 2024 on the challenges and future role of artificial intelligence and machine learning in pharmacovigilance. The webinar was delivered by Dr Dirk Mentzer, Head of Safety of Biomedicines and Diagnostics Division, Paul Ehrlich Institut.

New lecture in series dedicated to Jordi Llinares: Problem of diversity in clinical trials and biomedical research (23/09/2024)

This session on the problem of diversity in clinical trials and biomedical research forms part of a series of lectures dedicated to Jordi Llinares, given by eminent experts on a broad variety of topics. You can obtain the connection link through your Training Champion.

Joint HMA/EMA multi-stakeholder workshop on pharmacogenomics (23/09/2024)

The European Commission, the Heads of Medicines Agencies and the EMA are organising a multi-stakeholder hybrid workshop on Pharmacogenomics.

Joint HMA/EMA multi-stakeholder workshop on submission predictability (25/09/2024)

This workshop brings together representatives from the national competent authorities, industry, and EMA, to focus on submission predictability and how it can be improved.

Scientific Symposium on Advanced Therapy Medicinal Products - Contribution, evolution, revolution (10/10/2024)

This symposium will showcase how the work of CAT has contributed to the regulatory framework for ATMPs in Europe and to the approval of these innovative products.

Fourth veterinary big data stakeholder forum (14/10/2024)

The annual edition of the Veterinary big data stakeholder forum is part of the implementation of the EU veterinary big data strategy.

Small and medium-sized enterprises info day (18/10/2024)

The SME info day is a training event dedicated to small and medium-sized enterprises in the pharmaceutical sector.

EU NTC Welcome - August 2024 (13/08/2024)

Data reliability - DARWIN EU - From onboarding of data partners to study planning - Real World Academy session 3 (09/09/2024)

This 3rd session of the Real World Academy aims to increase the understanding of the level of quality of real-world data (RWD) held by DARWIN EU data partners so that attendees feel more confident in their use in RWD studies and regulatory decisions.

Risk Management Plans: procedure management and assessment (12/09/2024)

This training is organised by the PRAC secretariat and the Pharmacovigilance office at EMA, with PRAC sponsorship. Note that the timing has been updated, the webinar will take place from 10:00 to 12:00.

2024 QWP training for quality assessors (03/10/2024)

Training for competent and advanced quality assessors organised by the Quality Working Party (QWP) and hosted by the National Authority of Medicines and Health Products in Portugal (Infarmed).

Implementation of IncreaseNET On the Job Training Programme: Roles, responsibilities and process for involvement of Training Assessor, Shadow Assessor and iRapporteur /iCoRapporteur in Centralised procedures (13/08/2024)

This training has been developed within Work Package 6 of the Joint Action “Supporting the Increased Capacity and Competence Building of the EU Medicines Regulatory Network” (IncreaseNET) – please see the 'Highlights' section for further information on IncreaseNET.

Induction Program for Newly Recruited Assessors Focusing on Regulatory Aspects (13/08/2024)

This is a general induction course for newly recruited assessors, developed within Work Package 5 of the Joint Action “Supporting the Increased Capacity and Competence Building of the EU Medicines Regulatory Network” (IncreaseNET) – please see the 'Highlights' section for further information on IncreaseNET.

Training on the guideline on quality, safety and efficacy of bacteriophages as veterinary medicines (13/08/2024)

This is a recording of a webinar held on 30 May 2024. This training has been developed in liaison with the CVMP Novel Therapies Working Party (NTWP).

Training on Clear Writing (13/08/2024)

This is a recording of a training given by the EMA Medical and Health Information office at EMA on 4 June 2024.

Quality assessor’s experiences with the assessment of nanomedicines and technical aspects on particle size characterisation of nanomedicinal products (13/08/2024)

This is a recording of a training developed jointly by BfArM and the EU Commission Joint Research Centre (JRC) and held on 13 June 2024.

Non-clinical evaluation of biosimilar medicinal products (13/08/2024)

This is a recording of a webinar held on 13 June 2024. The course was developed in liaison with the Nonclinical Working Party (formerly Safety Working Party) as part of the non-clinical curriculum.

Changes foreseen by the new fee regulation and the Working Arrangements between EMA and the Network (13/08/2024)

This is a recording of a webinar held on 15 July 2024. The course was developed by the EMA Finance Department.

Consolidated advice pilots: information and training webinar for Assessors and Regulators (13/08/2024)

This is a recording of an information and training webinar session held on 15 July 2024, following the launch of two advice pilots (SAWP-CTCG and pre-CTA advice) aimed at improving the quality of applications for clinical trials, ACT EU.

Ethical considerations in international clinical trial site selection (13/08/2024)

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.

Talk on the African Medicines Agency and the EU Network (13/08/2024)

This is a recording of a talk held on 27 June 2024. The talk aimed to raise awareness for the EU Network about the African Medicines Agency (AMA) and regulatory systems strengthening in Africa.

Multi-stakeholder workshop on Pharmacogenomics (24/09/2024)

The European Commission, the Heads of Medicines Agencies and the EMA are organising a multi-stakeholder hybrid workshop on Pharmacogenomics at EMA.

Training on workbook for assessors on streamlining the list of questions (clinical aspects) (12/07/2024)

The workbook for assessors on streamlining the list of questions was developed to create focused questions and help assessors determine the true value of concerns during assessments and decide which merit inclusion in the Overview or Assessment Report.

BWP-CAT training on AAV based gene therapy (12/07/2024)

This is a recording of a training developed by the Biologics Working Party (BWP) in collaboration with the Committee for Advanced Therapies (CAT) and held on 31 May 2024.

Joint Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) multistakeholder workshop (12/07/2024)

This is a recording of the second day of a joint HMA / EMA multistakeholder workshop on patient registries held on 12 - 13 February 2024. The course consists of 4 videos, each approximately 1 hour in length.

Network update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS (12/07/2024)

This is a recording of a webinar which took place on 18 June 2024.

Benchmarking of European Medicines Agencies (BEMA) V cycle virtual training (12/07/2024)

This is a recording of a 2-day hybrid training event (with participation both in person and online) held on 30 - 31 January 2024 in view of the upcoming BEMA V cycle. This training was developed by the BEMA steering group and organised by the BEMA secretariat, in collaboration with the EMA Audit Office.

Gene editing and its relevance for innovative treatments (12/07/2024)

This is a recording of a webinar lecture given on 18 April 2024 by Dr Lluis Montoliu Ph.D., a CSIC Research Scientist and Deputy Director at the National Centre for Biotechnology, Madrid.

How to ensure data quality in the generation of real-world evidence (RWE) (12/07/2024)

This session of the Real World Academy focused on the data quality of Real World Data. It is targeted at assessors and EMA product team members/other staff dealing with RWD.

Q&A clinic for IRIS Network users for transitioned regulatory procedures (12/07/2024)

This is a recording of a webinar which took place on 23 May 2024.

Consolidated advice pilots: information and training webinar for applicants (17/07/2024)

This information and training webinar session follows the launch on 10 June of two advice pilots (SAWP-CTCG and pre-CTA advice) aimed at improving the quality of applications for clinical trials, ACT EU.