Getting involved in EMA activities as a healthcare professional
Healthcare professionals are involved in a wide range of European Medicines Agency (EMA) activities.
EMA interacts with general practitioners, nurses, hospital and community pharmacists, specialist doctors and representatives of learned societies.
Healthcare professionals are involved as either representatives of European Union (EU) healthcare professionals' organisations, representatives of their own organisations or as individual experts, depending on the nature of the activity.
- Representing their community
- Representing their organisations
- Healthcare Professionals' Working Party (HCPWP)
- EMA consultations
- Workshops
- As individual experts
- Scientific Advice / Protocol Assistance Procedures
- Scientific Advisory / ad hoc expert groups
- Scientific committee consultations
- Review of documents
Overview of involvement along the medicines lifecycle
Healthcare professionals can get involved at EMA in every aspect of the regulatory lifecycle of a medicine from pre-submission and evaluation through to post-authorisation.
They participate in committee and expert meetings and also contribute to certain types of documents.
Lifecycle overview of involvement in meetings and outputs
Early dialogue in medicine development
Areas of involvement:
Orphan designation
COMP
Advanced therapy classification
CAT
Paediatric investigation plan
PDCO
Scientific advice
SAWP
Evaluation and authorisation
Areas of involvement:
Marketing authorisation evaluation
CHMP | CAT | PRAC
Orphan designation maintenance
COMP
Scientific advisory / ad hoc expert groups
CHMP | PRAC
Safety monitoring of medicines
Areas of involvement:
Post marketing procedures
CHMP | CAT | PRAC
Safety communications | Direct healthcare professional communications
Scientific advisory / ad hoc expert groups
CHMP | PRAC
Public hearings
PRAC
Getting involved by representing an organisation
Any not-for-profit organisation that fulfils the following eligibility criteria is welcome to express its interest in getting involved in the work of EMA:
- legitimacy, with statutes registered in the EU;
- clear mission and objectives with an interest in medicines;
- being representative of healthcare professionals throughout the EU;
- adequate structure and consultation modalities;
- transparency.
The full details are available in the documents below.
Interested organisations should fill in the following application form and send it to EMA together with any supporting information. The Agency welcomes applications at any time and will send an acknowledgment of receipt after receiving the application:
EMA informs all organisations of the outcome of the evaluation of their application. EMA publishes information on eligible organisations on Eligible healthcare professionals' organisations.
Eligibility is re-assessed annually. For more information, see:
Getting involved as an individual
Healthcare professionals, as specialists in their area, contribute their clinical expertise directly into scientific regulatory discussions.
EMA contacts experts primarily via its network of eligible organisations.
Healthcare professionals interested in engaging with EMA can express their interest by registering to be included in EMA's individual stakeholder database via the link below.
The database’s main purpose is to identify healthcare professionals to participate in EMA activities and disseminate information relevant to individuals’ areas of interest.
Individuals invited to participate in EMA activities must register in EMA's experts database as ‘medicines experts’ before taking part, particularly in activities related to medicine assessment. EMA will provide instructions on how to create an account and complete the registration process.
In parallel, you can also choose to apply to EMA's open calls for remunerated external experts:
All experts involved in EMA activities must comply with the Agency’s competing interests policy.