Home › Guides › EMA training: how the European Medicines Agency works

EMA training: how the European Medicines Agency works

EMA training means learning how the European Medicines Agency works and how to deal with it. The EMA assesses medicines for the centralised procedure through its scientific committees, coordinates inspections and safety monitoring, and runs EU systems such as EudraVigilance and CTIS. It does not grant licences itself; the European Commission does, on the EMA's opinion. Most daily regulatory work also involves national agencies, so good training covers the whole EU network, not only the agency in Amsterdam.

5 related courses
44 hours of audio across them
certificate and training record
delivered in 72 hours

What does the European Medicines Agency do?

The EMA coordinates the scientific assessment of medicines in the EU. Its committees, led for human medicines by the CHMP, review applications in the centralised procedure, monitor safety and give opinions. The agency also coordinates GMP and pharmacovigilance inspections, keeps EU databases such as EudraVigilance, and runs CTIS for clinical trials. It works with the national agencies of every member state, which carry out most of the inspections and handle the national, decentralised and mutual recognition procedures.

How does an EMA inspection run?

The EMA asks a national authority to inspect, and that authority’s inspectors do the work. For a manufacturing site the inspection covers the quality system, production, quality control and data integrity, over several days. Findings are graded, the site answers with a corrective action plan, and the result is shared across the EU network.

What EMA CTIS training covers

The CTIS training material explains how to register, manage user roles, prepare and submit an application, respond to requests for information and publish results. It is practical and free. It does not replace knowing the clinical trials regulation itself: the deadlines, the transparency rules and what each part of the application must contain.

What a regulatory team needs to know about the EMA

New starters need a map of who decides what in the EU: the EMA, the Commission, the national agencies and bodies such as the EDQM. Teams running trials need CTIS and the regulation behind it. Marketing authorisation holders need their yearly obligations and how inspections work. The courses below cover those layers by role, with a recorded questionnaire at the end of each module.

This guide belongs to Regulatory affairs by region: 31 audio courses for your team, 31 courses.

Courses that teach this, priced per learner per year

Each course is audio modules in three lengths, with workbook, transcript, a recorded questionnaire per module, a certificate and the training record. Prices are the list price per learner for a year; the price falls with more learners.

Request a free sample module See the whole catalog

Questions about EMA training

Does the EMA offer training courses?

The EMA publishes free guidance and training material for its own systems, such as CTIS and EudraVigilance, and holds information days. It does not run general courses for industry staff on how to work in EU regulation. Those come from universities, associations and private providers.

What is an EMA inspection?

An inspection requested or coordinated by the EMA, usually for a centrally authorised product. The inspectors come from national authorities in the EU. They inspect manufacturing sites, clinical trial sites and pharmacovigilance systems, inside and outside the EU, and report back to the EMA committees.

What is EMA CTIS training?

CTIS is the Clinical Trials Information System used for all clinical trial applications in the EU. The EMA publishes an online training programme, guides and videos for sponsors and authorities. It explains how to use the system, but not the wider rules of the regulation behind it.

Is MHRA training the same as EMA training?

No. Since the start of 2021 the UK has its own system under the MHRA, separate from the EMA. Many principles are close, but procedures, timelines and submission routes differ. A company selling into both markets needs to know both.

What does the CHMP do?

The CHMP is the EMA's committee for medicines for human use. It assesses applications in the centralised procedure and gives an opinion on whether a medicine should be authorised. The European Commission then takes the legally binding decision, usually within a few months.

Is the course certificate an EMA certification?

No. The EMA does not certify training courses or people. The certificate records that a named person completed the course and its questionnaires, with hours, guideline version and date. It is evidence of training, not a regulator's approval, a professional qualification or an accreditation.

Other guides

All guides