IRIS for Good Pharmacovigilance practice (GVP) inspections training session f...
Wednesday, September 7, 2022

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Introduction to Referentials Management Service (RMS): Industry webinar
Wednesday, August 31, 2022

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Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) Information ses...
Wednesday, August 31, 2022

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Introduction to Organisation Management Service (OMS): Industry webinar
Tuesday, August 30, 2022

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Multi-stakeholder workshop: Patient experience data in medicines development ...
Wednesday, August 17, 2022

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Clinical Trials Information System (CTIS): Walk-in clinic
Wednesday, August 10, 2022

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Training session for patients, consumers and healthcare professionals involve...
Monday, July 25, 2022

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DADI PDF electronic application forms (eAF) training webinar
Monday, July 25, 2022

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European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and...
Wednesday, May 25, 2022

The first joint meeting of the new mandate (2022-25) of the ‘Patients and Consumers’ (PCWP) and ‘Healthcare Professionals’ (HCPWP) Working Parties will begin with introduction of the members followed by a discussion on issues related with clinical trials and the ongoing review of the ICH E6(R3) G... .. read more..

Information day for micro, small and medium-sized enterprises (SMEs) : EMA su...
Friday, August 20, 2021

The information day will provide an overview of the initiatives of the European medicines agency (EMA) supporting SMEs and service providers operating in the veterinary medicines sector. It will highlight platforms for early dialogue with EMA, the range of support that companies can access to opt... .. read more..

Risk management information day
Friday, April 23, 2021

The focus of this information day will be an update of the European Medicines Agency’s (EMA) ongoing activities on medicines’ risk management with the opportunity for an interactive platform to exchange experiences between regulators and industry. .. read more..

Veterinary big data stakeholder forum
Friday, April 23, 2021

In recent years, reflections have progressed on how medicines regulation could be enhanced by digital technologies. Whilst substantial advancements occurred in the use of such solutions in the regulation of medicines for human use, the use of digital technologies in the veterinary regulatory doma... .. read more..

Data standards strategy workshop
Friday, April 2, 2021

The European medicines agency (EMA) has launched an initiative to develop a data standards strategy, with a view to addressing the big data task force’s recommendation to engage in international initiatives related to data standardisation. .. read more..

Workshop on artificial intelligence in medicines regulation
Thursday, April 1, 2021

Artificial intelligence (AI) and novel digital technologies hold the promise of increasing efficiency and capacity in healthcare and of providing deeper insights from big data. .. read more..

Real world research on medicines: contribution of the European network of cen...
Wednesday, February 17, 2021

The aim of this webinar is to provide the opportunity for academic communities and learned societies to gain a better understanding of: .. read more..

EMA's EU big data stakeholder virtual forum
Wednesday, December 2, 2020

The European medicines agency’s (EMA) EU big data stakeholder forum will be held as a virtual meeting. .. read more..

Public stakeholder meeting: development and authorisation of safe and effecti...
Wednesday, December 2, 2020

The European medicines agency (EMA) is organising this virtual meeting to explain the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role, to all interested parties. .. read more..

EudraVigilance information day
Thursday, November 26, 2020

This information day will provide an update of some key elements and activities that will impact EudraVigilance and its stakeholders in the coming years. The objective is to outline technical and operational activities with anticipated timelines and to highlight how the database and the users tha... .. read more..

Workshop on support for orphan medicines development
Wednesday, November 25, 2020

This virtual event, organised by the European Medicines Agency (EMA), aims to encourage early and efficient interactions with the regulators by highlighting pre-marketing support in medicine development in rare diseases. .. read more..

Multi-stakeholder webinar to support the implementation of the Medical Device...
Wednesday, November 25, 2020

This multi-stakeholder workshop is held by the European Medicines Agency (EMA) in preparation for the changes introduced by Article 117 of the regulation (EU) 2017/745 on medical devices for integral drug-device combinations. These require notified bodies to be involved in the assessment of certa... .. read more..

EMA roundtable with stakeholders on the 15-year anniversary of the SME regula...
Tuesday, November 24, 2020

The European medicines agency (EMA) is hosting a roundtable meeting with stakeholders to mark the 15th anniversary of the implementation of EMA’s SME regulation. .. read more..

Workshop on the application of the General Data Protection Regulation (GDPR) ...
Thursday, July 23, 2020

This virtual workshop, organised by the European Medicines Agency (EMA), will provide an overview of the European Commission’s work on the creation of a European Health Data Space, followed by a discussion on the development of an EU-wide governance framework and a future code of conduct on the p... .. read more..

Workshop on benefit-risk of medicines used during pregnancy and breastfeeding
Thursday, July 23, 2020

It is the ambition of the European Medicines Agency (EMA) that in the medium to long term, women should have sufficient information, provided appropriately, to enable decision making on their medical treatment, given their (plans for) pregnancy or given they wish to breastfeed their baby. .. read more..

From data to evidence in medicines regulation
Wednesday, June 24, 2020

The European Medicines Agency (EMA) is holding this conference as part of a programme of events to celebrate its 25th anniversary. .. read more..

Multi-stakeholder workshop to launch consultation on European Medicines Agenc...
Wednesday, December 5, 2018

This multi-stakeholder workshop aims at gathering initial thoughts on the key areas to be covered in the current reflection on the European Medicines Agency’s (EMA) regulatory science to 2025 and will share proposals for veterinary medicines. .. read more..

Innovation and biomarkers in cancer drug development (IBCD) 2018
Wednesday, November 7, 2018

The ‘Innovation and biomarkers in cancer drug development (IBCD) 2018’ event will embrace the full environment and explore routes through the constantly evolving scientific, methodological and regulatory environment. .. read more..

EC-HMA-EMA joint workshop on electronic product information
Wednesday, November 7, 2018

The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) are working together to facilitate the development of electronic tools to improve access of patients and healthcare professionals to the EU product information. Electronic formats bring ne... .. read more..

Risk management plan information day
Tuesday, October 16, 2018

This information day will update participants on the medicine risk management activities of the European Medicines Agency (EMA) and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP). It will also provide an opportunity for an exchange of exp... .. read more..

Multi-stakeholder workshop to launch consultation on European Medicines Agenc...
Tuesday, October 16, 2018

The European Medicines Agency (EMA) is holding a multi-stakeholder workshopto gather initial thoughts on the key areas for human medicines to be covered in EMA’s regulatory science to 2025. .. read more..

Information day for micro, small and medium-sized enterprises (SMEs): regulat...
Friday, July 6, 2018

This SME information day will provide an update on regulatory affairs topics for developers of human medicines and combined devices. .. read more..

Workshop on the development of antimicrobial medicinal products for paediatri...
Monday, June 11, 2018

The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency and the United States' Food and Drug Administration (FDA) are co-organising this workshop to discuss the development of antibiotics for children. This will provide an opportunity for international regulat... .. read more..

Update on Brexit regulatory preparedness activities for veterinary companies
Tuesday, March 13, 2018

The European Medicines Agency (EMA) is holding this meeting to give an update on EMA Brexit preparedness activities and address any specific questions industry stakeholders may have further to the publication of European Commission and EMA questions and answers document and EMA procedural guidance. .. read more..

European Medicine Agency veterinary medicines innovation day
Tuesday, March 13, 2018

The purpose of the European Medicines Agency (EMA) veterinary medicines innovation day is to raise awareness and promote the support and measures that EMA has to offer in the area of veterinary medicines innovation. The event is aimed at industry, including micro-, small- and medium-sized enterpr... .. read more..

Multi-stakeholder workshop to further improve the implementation of the paedi...
Tuesday, March 13, 2018

This workshop, organised by the European Medicines Agency (EMA) and the European Commission, follows the publication of the Commission’s ten-year report on implementation of the paediatric regulation and the state of paediatric medicines in the EU. .. read more..

European Medicines Agency (EMA) information day on risk management planning
Tuesday, December 5, 2017

This information day is aimed primarily at providing marketing authorisation holders and marketing authorisation applicants with practical advice on risk management plans (RMP) drafting, using the principles of risk assessment and management included in good pharmacovigilance practice (GVP) modul... .. read more..

EudraVigilance information day
Tuesday, December 5, 2017

This EudraVigilance information day, organised by the European Medicines Agency (EMA), provides a forum to discuss, among others, the very initial experience of stakeholders with the new EudraVigilance system functionalities following its launch in November 2017. .. read more..

A common data model in Europe? – Why, which and how?
Tuesday, December 5, 2017

This meeting, organised by the European Medicines Agency (EMA), will aim to define the opportunities and challenges in applying a common data model in Europe to support regulatory decision-making and agree on guiding principles for the development of such a model, including key criteria for valid... .. read more..

Data anonymisation workshop
Friday, November 17, 2017

The data anonymisation workshop, organised by the European Medicines Agency (EMA), focuses on anonymisation as a key enabler for clinical data sharing. The scope of the workshop includes clinical trial data including individual patient level data and real world data in the context of patient regi... .. read more..

EMA/DIA signal management information day
Wednesday, October 4, 2017

This information day, jointly organised by the European Medicines Agency (EMA) and the Drug Information Association (DIA), provides an update on essential signal detection and management activities in the EU for the overall surveillance and risk management of medicines. .. read more..

SME info day: Supporting innovatives medicines’ development and early access
Thursday, August 31, 2017

This event covers topics such as EU initiatives targeting SMEs and early interactions with regulators. It further discusses scientific advice and its impact on marketing authorisation outcomes and go into the details of the range of scientific advice that companies can benefit from (protocol assi... .. read more..

Joint European Medicines Agency (EMA)/Drug Information Association (DIA) info...
Thursday, August 31, 2017

Measuring the impact of pharmacovigilance is essential to allow regulators and pharmaceutical industry to ensure key pharmacovigilance activities are effective and efficient and to support regulatory decisions. Effective risk minimization, balancing benefits and risks of medicines, are important ... .. read more..

2d paediatric strategy forum on medicine development for mature B cell malign...
Thursday, August 31, 2017

This second multi-stakeholder paediatric strategy forum, jointly organised by ACCELERATE and the European Medicines Agency (EMA), will focus on mature B cell malignancies (lymphoma and leukaemia) in children. .. read more..

EudraVigilance information day
Tuesday, July 25, 2017

The EudraVigilance information day, organised by the European Medicines Agency (EMA), provides a forum to discuss the final steps in preparation of the simplified adverse reaction reporting, the new signal management for marketing authorisation holders in the European Economic Area (EEA) as well ... .. read more..

Introduction to the EU regulatory system and EMA for international regulators...
Tuesday, July 25, 2017

This two-day awareness session is for international regulators and non-governmental organisations. It gives an insight into the EU regulatory system for medicines and the role of the European Medicines Agency (EMA). .. read more..

EudraVigilance information day
Wednesday, May 31, 2017

This European Medicines Agency (EMA) information day on EudraVigilance provides a forum to prepare stakeholders for the implementation and launch of the new EudraVigilance system in the context of the pharmacovigilance legislation and to facilitate change management as part of the EMA’s pharmacov... .. read more..

EMA workshop on revising the guideline on strategies to identify and mitigate...
Friday, March 24, 2017

This technical workshop, organised by the European Medicines Agency (EMA), aims at finalising guidance on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products, with further involvement of stakeholders including from other regulatory ... .. read more..

7th Framework Programme (FP7) small-population research methods projects and ...
Thursday, March 2, 2017

3 projects (Asterix, IDeAl and InSPiRe) are funded by the EU within the FP7 to develop new methodology on design and analysis of small population clinical trials since 2013. The projects are in their final phase, and are ready to discuss their results to date. .. read more..

SME information day on the new clinical trial regulation
Thursday, March 2, 2017

This SME information day, organised by the European Medicines Agency (EMA), provides an overview on the key features and objectives of the new clinical trial regulation. It also covers the future clinical trial authorisation process, the functionalities of the European clinical trial (EU CT) port... .. read more..

EMA human scientific committees' working parties with patients’ and cons...
Thursday, March 2, 2017

This joint PCWP/HCPWP meeting, organised by the European Medicines Agency (EMA), will include discussions on the EMA annual report 2016; on the interaction with patients, consumers, healthcare professionals and their organisations; the work plans for 2018-19; the outcome of the Committee for medi... .. read more..

Joint European Directorate for Quality of Medicines and Healthcare (EDQM) and...
Friday, February 3, 2017

The EU plays a leading role in the development of the concept of biosimilars and their assessment. The European Pharmacopoeia (Ph. Eur.) has driven the setting of quality standards for biotherapeutic products in Europe for more than two decades. While to date 21 biosimilars have been approved in ... .. read more..

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