Services to design, develop, and deliver e-learning in the field of pharmaceutical quality assessment, clinical and non clinical assessment

The provided data outlines a call for tenders issued by the European Medicines Agency (EMA) focused on procuring services for the design, development, and delivery of e-learning courses aimed at enhancing the scientific and regulatory capacities of junior assessors in National Regulatory Authorities within the African continent. The tender is structured into three distinct lots: Lot 1 emphasizes pharmaceutical quality assessment, Lot 2 focuses on clinical assessment, and Lot 3 targets non-clinical assessment. Each lot has a total estimated value, with Lot 1 and Lot 3 at 375,000 EUR each, and Lot 2 at 400,000 EUR. The overall estimated contract value amounts to 1,150,000 EUR.

Eligible participants include legal entities registered within the EU and natural persons domiciled in the EU, while subcontractors are exempt from certain market access restrictions. The tender’s application type is an open call, requiring submissions through the EU's electronic Funding and Tenders Portal.

The e-learning materials developed must be available in English, French, and Portuguese, reflecting the linguistic capabilities of the target audience. The services include creating training curricula and producing self-learning training materials, indicating a focus on both curriculum design and course delivery.

The contract duration for each lot is set at 12 months with a possible extension for an additional 12 months, culminating in a maximum total contract duration of 24 months. Tender submissions must be submitted electronically by June 18, 2025, with strict adherence to submission guidelines outlined in the tender documentation.

The selection criteria will include the tenderers' professional capacity, economic and financial standing, as well as technical and professional abilities. Evaluation of tenders will be based on a best price-quality ratio, with awards determined by these criteria.

Various documents related to the tender process are available for download, including costing sheets, contractual agreements, and technical specifications. A detailed FAQ section addresses common queries regarding submission processes, eligibility requirements, and documentation standards.

In summary, this tender presents an opportunity for organizations skilled in educational content development to collaborate with EMA in delivering vital training materials, enhancing regulatory expertise amongst junior assessors in Africa.

This is a call for tenders, procedure identifier EMA/2024/OP/0013, published by the European Medicines Agency (EMA). The purpose is to procure learning services in the form of training curriculum and e-learning course development. These services aim to strengthen the scientific and regulatory capacity of junior assessors in National Regulatory Authorities on the African continent. The e-learning courses and curriculum are intended for junior assessors working in these authorities.

The services include: developing a training curriculum, developing e-learning courses, and producing self-learning training material. The e-learning material must be produced in English, French, and Portuguese.

The procedure is divided into three lots:
Lot 1: Design, develop, and deliver e-learning in pharmaceutical quality assessment.
Lot 2: Design, develop, and deliver e-learning in clinical assessment.
Lot 3: Design, develop, and deliver e-learning in non-clinical assessment.

The estimated total value of the tender is 1,150,000 EUR. The TED publication date is 16/04/2025. The lead contracting authority is the European Medicines Agency (EMA). The main classification (CPV) is 80000000 Education and training services.

Each lot has a maximum contract duration of 24 months. The award method is based on the best price-quality ratio. The estimated value for each of the three lots is 375,000 EUR, except for Lot 2 which is 400,000 EUR. The procedure involves a framework agreement without reopening of competition.

Selection criteria include: Suitability to pursue the professional activity, Economic and financial standing, and Technical and professional ability. All details are available in the procurement documents.

Key milestones:
TED publication date: 16/04/2025
Date and time of public opening: 18/06/2025 14:00 Amsterdam time
Deadline for receipt of tenders: 18/06/2025 12:00 Amsterdam time
Contracting authority is not bound to reply to questions submitted after: 10/06/2025 05:00 Amsterdam time

The following documents are available for download:
Invitation to tender.docx Invitation letter, published on 16/04/2025, Version 1, for all lots.
EMA-2024-OP-0013-Annex II (a) (b) (c) Costing sheet-All Lots Financial offer form, published on 23/05/2025, Version 2, for all lots.
EMA-2024-OP-0013 - Annex III - Declaration on Honour Declaration on honour (tender), published on 16/04/2025, Version 1, for all lots.
EMA-2024-OP-0013-Annex VIII _DRAFT Contract_All lots Draft contract, published on 16/04/2025, Version 1, for all lots.
EMA-2024-OP-0013-Annex VIII.1 - Draft Service Level Agreement Draft contract annex, published on 16/04/2025, Version 1, for all lots.
EMA-2024-OP-0013 - Annex VI - Subcontractors Other invitation to tender document, published on 16/04/2025, Version 1, for all lots.
Annex VII Letter of intent Other invitation to tender document, published on 16/04/2025, Version 1, for all lots.
EMA-2024-OP-0013-Annex IX Evidence Template -All Lots Other invitation to tender document, published on 16/04/2025, Version 1, for all lots.
EMA-2024-OP-0013 - Annex IV- Minimum technical requirements declaration-all LOTS Other invitation to tender document, published on 16/04/2025, Version 1, for all lots.
EMA-2024-OP-0013 - Annex I - Tenderer information sheet & declaration on tender submission Other invitation to tender document, published on 16/04/2025, Version 1, for all lots.

Submissions must be sent exclusively via electronic submission.

Some frequently asked questions (FAQ) and their answers are provided, covering topics such as documentation for entities, submission of multiple offers, participation of UK-based companies, domicile requirements for team members, extension of deadlines, deliverable clarifications, evidence for past experience, commitment letters for external experts, detailing estimated time, payment arrangements, contract duration, acceptability of training samples, rules of access to the market, inclusion of non-EU organizations, costing sheet calculations, submission of CVs, subject matter experts, and the use of specialized service providers.

The eSubmission system supports the latest versions of Google Chrome and Mozilla Firefox. Attachments should be less than 50 MB, and the maximum number of documents per tender is 200. A Personal Identification Code (PIC) is mandatory for tenderers. The system supports 24 official EU languages and uses UTF-8 character set encoding. The system encrypts all uploaded documents.

In summary, this tender is an opportunity for organizations to provide e-learning services to the European Medicines Agency, specifically targeting the training of junior assessors from African National Regulatory Authorities. The project involves developing training curricula and e-learning courses in pharmaceutical quality, clinical, and non-clinical assessment, with materials in English, French, and Portuguese. The tender is divided into three lots, each with a maximum contract duration of 24 months and an estimated value. The submission deadline is June 18, 2025, and electronic submission is mandatory. A new version of Annex II Costing Sheet has been published.

Eligible Applicant Types: The eligible applicant types are legal entities registered in the EU and all natural persons having their domicile in the EU. The rules of access to the market prohibit the participation of economic operators established in the United Kingdom as sole tenderers or as leaders of a group of tenderers. Subcontractors are not subject to these rules of access to the market.

Funding Type: The funding type is procurement, specifically a service contract.

Consortium Requirement: Both single applicants and consortia are allowed. Participation in the form of joint tender is open to all legal entities registered in the EU and all natural persons having their domicile in the EU.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility for applicants is primarily focused on the EU. Natural persons must have their domicile in the EU. The call for tenders is specifically targeted at strengthening the scientific and regulatory capacity and capability of junior assessors on the African continent, although the work is carried out by EU-based entities.

Target Sector: The target sectors are education and training, specifically in the field of pharmaceutical quality assessment, clinical assessment, and non-clinical assessment. The tender focuses on the design, development, and delivery of e-learning courses.

Mentioned Countries: United Kingdom, EU, African continent

Project Stage: The project stage is development and delivery of e-learning courses. The tender specifies developing a training curriculum, developing e-learning courses, and producing e-learning material.

Funding Amount: The estimated total value of the procedure is 1,150,000 EUR. The estimated value per lot is 375,000 EUR for Lot 1 and Lot 3, and 400,000 EUR for Lot 2.

Application Type: The application type is an open call for tenders.

Nature of Support: Beneficiaries will receive money in exchange for services rendered, specifically the design, development, and delivery of e-learning courses. Payments shall be made in arrears following receipt of an invoice and completion of services, either on a monthly basis or longer as agreed.

Application Stages: The number of application stages is not explicitly stated, but it involves at least the submission of a tender, evaluation of the tender, and potential contract award.

Success Rates: The success rates are not mentioned in the provided text.

Co-funding Requirement: Co-funding requirements are not mentioned in the provided text.

Summary:

This is a call for tenders by the European Medicines Agency (EMA) to procure services for the design, development, and delivery of e-learning courses aimed at strengthening the scientific and regulatory capacity of junior assessors in National Regulatory Authorities in the African continent. The tender is divided into three lots: pharmaceutical quality assessment, clinical assessment, and non-clinical assessment. The e-learning courses must be produced in English, French, and Portuguese.

Eligible tenderers include legal entities registered in the EU and natural persons domiciled in the EU. Subcontractors are also permitted, and the rules of access to the market do not apply to them. The submission method is electronic, and the deadline for receipt of tenders is June 18, 2025, at 12:00 Amsterdam time. The EMA is using an eSubmission system, and tenderers must adhere to the system's technical requirements. The initial contract duration for each lot is 12 months with a possible renewal for a further 12 months, i.e. total maximum contract duration is 24 months.

The tender documents include an invitation letter, costing sheets, a declaration on honor, a draft contract, a draft service level agreement, a subcontractors annex, a letter of intent annex, an evidence template annex, a minimum technical requirements declaration, and a tenderer information sheet. Tenderers are expected to provide prices for full-day and half-day services, inclusive of all costs related to the provision of services. Payments will be made in arrears after the completion of services and receipt of an invoice. The total estimated value of the tender is 1,150,000 EUR, with individual lots valued at 375,000 EUR (Lots 1 and 3) and 400,000 EUR (Lot 2).