Trainee (Research on psychostimulants' off-label use in paediatric and young adults patients)

About the traineeship programme

The Agency is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students or Master's students (who posses a previous degree), who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.

Placement description

We are looking for a trainee in the Therapeutic Areas Department.

Specific objectives and projects

As a trainee in the 'therapies for neurological and psychiatric disorders' (TA-NEU) office you will be involved in 3 projects:

1)  A study proposal: Drug utilisation study of psychostimulants’ off-label use in paediatric and young adults patients.

Background:

PDCO (Paediatric Committee) recognised the research needs in the area of child and adolescent psychiatry, including for CNS stimulants. There is evidence of harm from off-label or unlicensed medicines use in children. Off-label use of psychostimulants in paediatric population is a long-standing known issue (e.g. methylphenidate, atomoxetine).

Psychostimulants (ATC codes N06B), authorized for conditions such as ADHD, have a risk of off-label use recognized in their Risk management plans and PSUSA assessments (EMEA/H/N/PSR/S/0029) (if this refers to an EMA public document, please add the hyperlink to it, otherwise remove it), but also their misuse or even abuse for not authorized purposes and cardiovascular safety concerns has been noted and assessed decade ago in the referral procedures (for example methylphenidate, modafinil and dexamfetamine).

EMA has recently received the external claim of current use of these active substances for “off-label use in young people and workers to improve their performance when study”.

Some of these authorized substances from ATC N06B psychostimulants group are on the List of Psychotropic Substances under International Control (dexamfetamine, methylphenidate), and it is expected that they are available on (restricted) prescription, which should minimize the possibility to be used for such off-label purposes.

There is a need for studies to explore up-to-date off-label usage of psychostimulant medicinal products in European paediatric and young adults patients in the clinical practice, especially since the adverse effects in children are shown to be more frequent, more serious and more underreported when medicines are used off-label.

This study will explore psychostimulant medicinal products utilisation patterns in European paediatric and young adults patients, in terms of: psychostimulant active substances, their co-administration with other medications, doses, duration of use, indication and present comorbidities, serious adverse drug reactions, prescribing doctors (GPs or specialists), paediatric and adults age categories (12-17, 18-30 years of age) and European countries (with available databases).

Specific objectives and projects (continuation)

Aims:

The aim of this study will be to (in line with EU Paediatric Regulation) raise awareness (in the network and prescribers) of research needs and off-label use of psychostimulants in paediatric and young adults patients, and fostering cross-agency collaboration.

Output:

Publication of results for prescribers (manuscript) and presentation for the network (CNS Community).

2)  Poster for congress: Pharmacogenomics information in the SmPCs (Summary of Product Characteristics) of Psychiatric CAPs (Centrally Authorised Products)

Context:

For the ECNP congress in Amsterdam, preparation of the poster presenting the overview of the pharmacogenomics (PGx) information contained in the CAPs SmPCs within TA-NEU Psychiatry.

Aims and output:

Presenting poster at the congress is expected to foster collaboration with the external stakeholders and raise awareness on the PGx importance in the Product information.

3)  Review of CNS (Central Nervous System) Business Portfolio meetings:

The project will involve retrospective review and analysis of the reports from the Business Portfolio meetings conducted in the CNS therapeutic area during 2020-2024 period.

Aims:

This data will be subsequently linked to current and future EMA activities intended to facilitate innovation and improve regulatory environment, such as development of new CNS guidelines and reflections papers.

It will also be used to brief Central Working Party and CNS ESEC members and help shape their work plan and activities.

Fostering cross-agency collaboration.

Output:

It is expected that the outcome of this project will be an external publication.

Eligibility criteria

To be eligible for consideration for this placement, you are required to:

1. enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2. possess a university degree in life sciences (minimum of three years or more) that must have been obtained between 6 May 2024 and 6 May 2025 or be a university student on an Erasmus + or a similar programme or a PhD student or a Master's student with a previous fully finished degree in the areas mentioned before.
3. a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the Common European Framework for Languages

For criteria 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the procedure.

Additional skills

•    Experience/knowledge with project Management.
•    Collaboration skills: Strong collaborative skills to foster partnerships and communication between different stakeholders.
•    Research and Analysis: Proficiency in conducting research, especially in the field of neuroscience and critical dose drugs.
•    Scientific Communication: Ability to prepare, present, and communicate complex scientific information clearly, such as creating posters for congresses.
•    Regulatory Knowledge: Understanding of the regulatory information in the Summary of Product Characteristics (SmPC) related to narrow therapeutic index/critical dose drugs.
•    Attention to Detail: Keen attention to detail to ensure accuracy and completeness in documentation and presentations.
 

Behavioural Competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills
• Learning and development

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2025 – 31 July 2026) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.

The Agency pays a monthly stipend of €1,942.19 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.

Each trainee will have a mentor at the Agency who will guide the trainee through the programme.

The conditions of employment are stated in the Executive Decision on rules governing the traineeship programme at the EMA available here.