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

The European Medicines Agency (EMA) is preparing a call for tenders identified as EMA/2024/OP/0013-PIN. This procurement opportunity involves services related to the design, development, and delivery of e-learning materials focused on pharmaceutical quality assessment, clinical assessment, and non-clinical assessment. The initiative aims to enhance the scientific and regulatory capabilities of junior assessors working in National Regulatory Authorities in Africa.

The e-learning services required include creating a training curriculum to establish learning objectives and competencies for each topic, developing e-learning courses to meet these competencies, and producing materials for self-directed learning. This procurement is segmented into three specific lots:

- Lot 1: E-learning materials for pharmaceutical quality assessment.
- Lot 2: E-learning materials for clinical assessment.
- Lot 3: E-learning materials for non-clinical assessment.

All educational materials must be produced in English, French, and Portuguese. Tenderers must demonstrate relevant experience working in Africa.

Eligible participants include natural and legal persons based in any EU Member State or European Economic Area (EEA) country, as well as nationals and established legal persons from countries within Sub-Saharan Africa.

The procedure will follow a planned call for tenders published in the Official Journal of the European Union, with a publication date initially scheduled for March 11, 2025, but now expected around mid-April 2025. The total duration of the contract is capped at 24 months, and this will be governed by a framework agreement that does not reopen competition once awarded.

The main classification for this contract falls under CPV code 80000000, which pertains to education and training services, and an additional classification of 79632000, which relates to personnel training services. Detailed procurement documents will be made available following the publication of the call for tenders.

In summary, this tender represents a significant opportunity aimed at developing and delivering educational programs to bolster regulatory skills for junior assessors in Africa, covering essential pharmaceutical and clinical topics in multiple languages. Interested entities with experience in the specified sectors are encouraged to partake in this tender process.

The European Medicines Agency (EMA) is planning a call for tenders, identified as EMA/2024/OP/0013-PIN, to procure services for the design, development, and delivery of e-learning materials in the fields of pharmaceutical quality assessment, clinical assessment, and non-clinical assessment. This initiative aims to strengthen the scientific and regulatory capacity of junior assessors in National Regulatory Authorities within the African continent. The curriculum and associated e-learning courses are specifically designed for these junior assessors.

The services to be provided must include: 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; and producing e-learning material, in particular self learning training material.

The procedure is divided into three lots:

Lot 1: Design, develop, and delivery of e-learning in pharmaceutical quality assessment.
Lot 2: Design, develop, and delivery of e-learning in clinical assessment.
Lot 3: Design, develop, and delivery of e-learning in non-clinical assessment.

The e-learning materials must be produced in English, French, and Portuguese. Tenderers must demonstrate experience working in the African continent.

Participation is open to:

(a) all natural and legal persons who have their domicile in or are registered in any European Union (EU) Member State and in any European Economic Area (EEA) country; and
(b) all natural persons who are nationals of, and legal persons who are established in any of the countries in Sub-Saharan Africa, as indicated here https://international-partnerships.ec.europa.eu/countries/sub-saharan-africa_en#countries-in-the-region.

The procedure type is a planned call for tenders with OJ S publication. The TED publication date was 27/01/2025. The lead contracting authority is the European Medicines Agency, MED. The main classification (CPV) code is 80000000 - Education and training services. The linked contract notice is EMA/2024/OP/0013. The nature of the contract is for services. The maximum contract duration is 24 months. The estimated date of publication of a contract notice was initially 11/03/2025, but the latest estimate is mid-April 2025. The contract is a framework agreement, without reopening of competition. The additional classification (CPV) code is 79632000 - Personnel-training services.

The procurement documents are not yet available, as this is a planned call for tenders.

In summary, this opportunity is a forthcoming tender from the European Medicines Agency for the development and delivery of e-learning training programs for junior assessors in African National Regulatory Authorities. The training will cover pharmaceutical quality assessment, clinical assessment, and non-clinical assessment, with materials in English, French, and Portuguese. The tender is divided into three lots, and companies with experience in the African continent are encouraged to apply. The call is expected to be published around mid-April 2025.

Eligible Applicant Types: The eligible applicant types are natural and legal persons who have their domicile in or are registered in any European Union (EU) Member State and in any European Economic Area (EEA) country, and all natural persons who are nationals of, and legal persons who are established in any of the countries in Sub-Saharan Africa. This includes private companies, as clarified in the Q&A section.

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

Consortium Requirement: A single applicant or a consortium of multiple applicants is acceptable, as a private company can apply individually.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes the European Union (EU) Member States, the European Economic Area (EEA), and countries in Sub-Saharan Africa. A link is provided to a list of eligible Sub-Saharan African countries: https://international-partnerships.ec.europa.eu/countries/sub-saharan-africa_en#countries-in-the-region.

Target Sector: The target sector is education and training services, specifically in the field of pharmaceutical quality assessment, clinical assessment, and non-clinical assessment. This falls under the broader categories of pharma/healthcare and education.

Mentioned Countries: The opportunity explicitly mentions the European Union (EU) Member States, the European Economic Area (EEA), the Netherlands, Turkey and countries in Sub-Saharan Africa.

Project Stage: The project stage involves the development and delivery of e-learning training curriculum and courses, suggesting a development and implementation stage.

Funding Amount: The estimated total value is not specified in the provided text.

Application Type: The application type is a planned call for tenders with OJ S publication.

Nature of Support: The beneficiaries will receive money in exchange for services.

Application Stages: The number of application stages is not explicitly stated, but it is implied that there will be at least one stage involving the submission of a tender.

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

Co-funding Requirement: The co-funding requirement is not mentioned in the provided text.

Summary:

This is a planned call for tenders by the European Medicines Agency (EMA) to procure services for the design, development, and delivery of e-learning training curriculum and courses. The goal is to strengthen the scientific and regulatory capacity of junior assessors in National Regulatory Authorities in the African continent. The e-learning courses will cover pharmaceutical quality assessment, clinical assessment, and non-clinical assessment. The e-learning material must be produced in English, French, and Portuguese. The procedure is divided into three lots, each focusing on one of the assessment areas. Eligible tenderers include natural and legal persons from the EU, EEA, and Sub-Saharan Africa. The estimated date of publication of a contract notice was initially 11/03/2025, but the latest estimate is mid-April 2025. The maximum contract duration is 24 months. This is a Prior Information Notice, and further details will be available in the Technical Specification to be published with the call for tenders.