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This traineeship placement is for a Trainee (Improving the availability of information on the medicines for older people) within the European Medicines Agency (EMA) in Amsterdam.
We are looking for a trainee in the Therapeutic Areas Department.
Specific objectives and projects
1) Building a Geriatric network database
Older people (≥65 years) represent an increasing share of the European population and are expected to make up around 30% of all Europeans by 2050. One of the main pillars of the EMA Geriatric Medicines Strategy is to ensure that medicines used by geriatric patients are of high quality and appropriately researched and evaluated throughout the lifecycle of the product for use in this population. This reflects the EMA Mission Statement, the EU Clinical Trials Regulation and ICH E7 and its Q&A guidelines.
However, the underrepresentation of older people in clinical trials for diseases that frequently occur in older age remains a recognised global issue. Various barriers contribute to this situation (as explored in the EU-funded PREDICT trial – Participation of the Elderly in Clinical Trials). Some barriers from the developers’ side, such as the need for geriatric expertise and considerations related to safety and trial design complexity, could be mitigated if a searchable database were available to identify institutions with geriatric expertise. A searchable expertise database already exists for paediatric drug development and is actively used (Enpr-EMA). A similar list of geriatric institutions could facilitate research and development by connecting geriatricians, patient organisations, research networks, investigators and centres with geriatric expertise.
2) Analysis of centrally authorised medicines for diseases highly prevalent in older age
a) Analysis of risk management plans (RMPs)
Risk management plans will be analysed to explore which of them specify the older population in safety concerns (e.g. important identified risks, potential risks or missing information). The analysis will also assess whether these RMPs include post-authorisation studies specifically addressing older patients. These results will be compared with the information available in European public assessment reports and in the product information.
b) Analysis of dosing information (as reflected in product information)
The analysis will assess what information is included in the “Special populations” subsection regarding the need for dose adjustments in older patients. This will be reviewed case by case in the context of relevant discussions in European public assessment reports and relevant EMA and scientific society guidelines.
Through this work, the trainee will:
To be eligible for consideration for this placement, you are required to:
Analytical skills, communication skills, proficient in using IT applications.
Considered beneficial: scientific writing, understanding of clinical safety, pharmacology, geriatric population specifics, pharmacovigilance, European public assessment reports (including Assessment reports, Product information, Risk management plans).
You will demonstrate the following behavioural competencies:
The traineeship is offered for 10 months (1 October 2026 – 31 July 2027) 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 €2,049.77 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.
Je bent op zoek naar een baan die past bij jouw ambities. Een baan in een internationale omgeving. Werken bij de EU is werken met collega's met een zeer gevarieerde culturele achtergrond. Er zijn carrièremogelijkheden in Brussel, Luxemburg en Straatsburg, maar ook elders in Europa en in de rest van de wereld. De EU biedt volop mogelijkheden voor kandidaten met zeer uiteenlopende opleidingen en ervaring.
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