Trainee (Develop EMA's translational use of PBPK models from dossier to labelling)

Selection procedure reference: EMA/TR/10471 

Deadline for applications: 20 May 2024 23:59 CET 

 

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It began operating in 1995. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

 

The 2024 Traineeship programme is now open for applications until 20 May 2024 23:59 CET, with an intake on 1 October 2024.

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 Translational Sciences Office within the Human Medicines Division.

Specific objectives and projects

During your traineeship, you will focus on the use of physiological based pharmacokinetic (PBPK) modelling, which is of increasing importance for drug-drug interactions, special populations and avoiding unnecessary clinical studies. Specifically, you will:

• Dive deeper into the review of EMA use of PBPK modelling first published in 2016 (https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.539) and an anticipated subsequent update to be published in 2024 (draft in progress).
• Provide a needs analysis based on this updated review to inform EMA on the life cycle of submitted PBPK models (with a particular focus on internal approaches EURS, eCTD software & databases, assessment reports etc).
• Support the development of a practical repository of submitted models for ease of reference and to help the Network and in particular the Modelling & Simulation Operational Expert Group of the Methods Working Party (MWP) with precedent, etc.
• Support the planned workshop in November 2024 on PBPK modelling and the subsequent update of relevant guidance. This will involve collaboration with MWP and CHMP and is also timely given the ongoing ICH harmonization of the requirements for model-informed drug development.

Learning outcomes

You will have the opportunity to:

• gain insight into the regulatory systems for use of PBPK modelling in the EU;
• gain insight into the cross-discipline approaches that may be required for assessment of PBPK models;
• develop a deeper understanding of modelling requirements for development and marketing authorisation of (complex) generics.

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 biomedical sciences, like pharmacy or medicine (minimum of three years or more) that must have been obtained within the last 12 months (graduated between 20 May 2023 and 20 May 2024) 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

In addition to the eligibility criteria, you will have:

 

• Organisational skills.
• Communication skills (English writing and verbal).
• Analytical methods and research skills.
• Advanced skills of Microsoft Powerpoint, Excel would be desirable.

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

Deadline for applications 20 May 2024 23:59 CET  Assessments (remote) From beginning of June 2024 to beginning of July 2024 Decision and offers By end of July 2024 Placement start 1 October 2024

 

Conditions of traineeship

The traineesh