Trainee (Analysis of agreement on partial waivers - lessons learnt and impact analysis)

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 Scientific Evidence Generation Department.

Specific objectives and projects

When agreeing Paediatric Investigations Plans, parts of the paediatric population may not needed to be studied ('partial waiver'), e.g. if the disease does not occur in children, if the product to be developed would likely be unsafe or inefficient and if it does not add any significant benefit. 

As the selected trainee, you will be involved in a project that aims to evaluate partial waiver requests, and resulting regulatory-scientific discussions during assessment and outcomes based on a representative sample of agreed paediatric investigation plans (PIPs). In collaboration with the RWE team, use of real world evidence (RWE) could provide  supportive data on prevalence and standard of care in populations excluded from PIPs.

It is also planned to include the analysis of the waivers granted in iPSPS in collaboration with FDA.

Your tasks will consist on data collection from the EMA repository of PIPs completed over a selected 2 year period. 

You would then build a database which would be analysed by a group of colleagues from EMA and PDCO (please spell achronym).

In more detail: EMA repository will be used to access the primary source data. Public assessment reports and published literature will be used as a secondary source. Basic data on the product (type, class, target, adult indication, paediatric indication [intended or PDCO requested], stage of development/regulatory status) will be collected. For each product basic details on waiver discussions will be collected. 

A qualitative analysis will then be performed on records for the justification of the partial waiver, either by the applicant or the Agency, whether there was an agreement for this position, and what provisions were incorporated in the PIP to cover the development for any additional patient group added to the initial PIP proposal. When questions for clarification were raised by the PDCO, these will be categorized, and responses will be coded accordingly. Data on subsequent reversal of these waivers through PIP modification will be also collected, where available. 

Following the analysis of the results, common themes will be identified in waiver discussions that allow a more efficient regulatory-scinetific discussion and where a more streamlined and predictable assessment methodology can be applied. 

A publication will be drafted and submitted to a peer reviewed journal (this can go on the learning outcomes).
 

Learning outcomes

You will gain knowledge about regulatory science project management, and the intricacies of drug development in children and regulatory aspects including the Paediatric Regulation in the EU. 

The project would include drafting and submitting a publication in a peer-reviewed journal, with the trainee as a co-author. 

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 medicine, pharmacy, epidemiology or natural 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

Some knowledge and experience in the area of paediatric medicines or epidemiology would be valuable

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.