Ausschreibungen European Medicines Agency, MED - European Medicines Agency

The services to be delivered by this procedure include the operation and maintenance of the DARWIN EU® Coordination Centre, the onboarding and maintenance of data partners, conduct of non-interventional studies in compliance with applicable Union data protection rules for a maximum period of five years (1+2+2 years).

The services to be delivered by this procedure include the operation and maintenance of the DARWIN EU® Coordination Centre, the onboarding and maintenance of data partners, conduct of non-interventional studies in compliance with applicable Union data protection rules for a maximum period of five years (1+2+2 years).

The European Medicines Agency (hereinafter referred to as “the Agency” or “EMA”) is planning to launch a tender procedure for the procurement of: a) legal advice in relation to the interpretation and implementation of the provisions of the Staff Regulations of Officials and Conditions of Employment of Other Servants of the European Union; the Protocol (No.7) on the Privileges and Immunities of the European Union; and other matters which may arise in relation to employment conditions of staff (“collectively referred to a, “EU staff matters”); and b) pre-litigation and litigation services in relation to the interpretation and implementation of the provisions of the Staff Regulations of Officials and Conditions of Employment of Other Servants of the European Union; the Protocol (No. 7) on the Privileges and Immunities of the European Union; and other matters which may arise in relation to EU staff matters. The scope of this procedure shall be to establish two framework contracts with two suitably qualified and experienced law firms, predominantly covering the provision of legal advice but also pre-litigation and litigation services in relation to EU staff matters. “Law firm” shall be understood as comprising practising lawyers as individuals, and “pre-litigation cases/matters” shall be understood as cases where legal advice is given in the preparation of arbitration or conciliation or judicial proceedings, or where there is tangible indication and high probability that the matter to which the legal services relate will become the subject of arbitration or conciliation or judicial proceedings. Regarding pre-litigation and litigation services in relation to EU staff matters, the Agency may require legal services in relation to appeals, complaints or disputes. The services envisaged by the EMA shall include, but are not limited to: • Advise the Agency on the elements and legal implications of the situation; • Draft and review documents and all cases related documents and assist in the preparation of the Agency’s defence ; • Draft replies to complaints and other correspondence as required ; • Participation in related meetings, usually by teleconference, and discussions as deemed necessary by the Agency ; • assist with the preparation of documents for written procedures and oral hearings, and ensure submission by e-curia or other appropriate means; and • legal representation of the Agency before the EU jurisdiction. The legal services which may be required will normally be provided at the premises of the law firms. However, some attendance outside the premises of the law firm may also be required (i.e. at the Agency’s premises in Amsterdam or at the Court of Justice of the European Union). An open procedure tender with a maximum indicative budget of €170,000 is planned to be launched in January 2026 and the contract awarded will be for an initial duration of one year, renewable three times each time for a period of one year. Hence the contract has a maximum duration of four years in total (1+1+1+1). The tenderer and their lawyers (as well as their alternates) proposed to be assigned to EMA must not be subject to conflicting interests, which may negatively affect the performance of the services of the contract. It follows that the tenderer and the tenderer’s staff shall not be in any situation that could compromise the impartial and objective performance of the contract with regard to the rendition of the said services.

The purpose of this call for tender is to contract an outsourced IT service desk to provide support services to EMA’s staff, contractors, and other stakeholders at its office premises in Amsterdam, the Netherlands, as well as to a wider stakeholder community across various locations, mainly within the European Union.

The purpose of this call for tender is to contract an outsourced IT service desk to provide support services to EMA’s staff, contractors, and other stakeholders at its office premises in Amsterdam, the Netherlands, as well as to a wider stakeholder community across various locations, mainly within the European Union.

The purpose of this call for tenders is to provide the European Medicines Agency with learning services in the form of training curriculum and e-learning courses development to strengthen the scientific and regulatory capacity and capability of juniors assessors on the African continent. The curriculum and its associated e-learning courses are intended for junior assessors working at National Regulatory Authorities in the African continent. The services to be provided must include at least: • developing a training curriculum to document the learning objectives and competencies required per the topic of each lot; • developing e-learning courses required to fulfil the competencies described in the curriculum; • producing e-learning material, in particular self learning training material In view of the different expertise and training areas required, the procedure is divided in 3 lots as follows: • Lot1: design, develop, and deliver e-learning in pharmaceutical quality assessment, • Lot2: design, develop, and deliver e-learning in clinical assessment, • Lot3: design, develop, and deliver e-learning in non-clinical assessment. E-learning must be produced in English, French and Portuguese.

The purpose of this call for tenders is to provide the European Medicines Agency with learning services in the form of training curriculum and e-learning courses development to strengthen the scientific and regulatory capacity and capability of juniors assessors on the African continent. The curriculum and its associated e-learning courses are intended for junior assessors working at National Regulatory Authorities in the African continent. The services to be provided must include at least: • developing a training curriculum to document the learning objectives and competencies required per the topic of each lot; • developing e-learning courses required to fulfil the competencies described in the curriculum; • producing e-learning material, in particular self learning training material In view of the different expertise and training areas required, the procedure is divided in 3 lots as follows: • Lot1: design, develop, and deliver e-learning in pharmaceutical quality assessment, • Lot2: design, develop, and deliver e-learning in clinical assessment, • Lot3: design, develop, and deliver e-learning in non-clinical assessment. E-learning must be produced in English, French and Portuguese.

Provision of data management services for data review, validation, cleansing and maintenance; document redaction and assessment; and customer service.

Continuity of services provision for catering and hospitality services for 2026 and 2027

The aim of this call for remunerated external experts is to establish a list of experts, individuals (natural persons) with scientific, regulatory and/or technical expertise pertaining to medicines for human use and veterinary medicinal products. External experts will support the Agency by providing advice to the Agency in scientific, regulatory and training activities within the scope of Article 57(1) of Regulation (EC) No 726/2004 and Regulation (EU) 2022/123 , as provided in Article 242 of Regulation (EU, Euratom) 2024/2509 (EU Financial Regulation ).