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

The purpose of this call for tenders is to provide the European Medicines Agency with learning services in the form of training curriculum and training courses development and delivery to strengthen the scientific and regulatory capacity and capability of juniors assessors on the African continent. The curriculum and its associated …

CPV: 79632000 Personalschulung, 80000000 Allgemeine und berufliche Bildung
Ausführungsort:
Services to design, develop, and delivery of e-learning in the field of pharmaceutical quality assessment, clinical and non clinical assessment
Vergabestelle:
European Medicines Agency, MED - European Medicines Agency
Vergabenummer:
EMA/2024/OP/0013-PIN

1. Buyer

1.1 Buyer

Official name : European Medicines Agency, MED - European Medicines Agency
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : Services to design, develop, and delivery of e-learning in the field of pharmaceutical quality assessment, clinical and non clinical assessment
Description : The purpose of this call for tenders is to provide the European Medicines Agency with learning services in the form of training curriculum and training courses development and delivery 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 delivery of e-learning pharmaceutical quality assessment, • Lot2: design, develop, and delivery of e-learning in clinical assessment, • Lot3: design, develop, and delivery of e-learning in non-clinical assessment. E-learning must be produced in English, French and Portuguese. Potential Tenderers have to demonstrate experience working in the African continent. Without prejudice to the provisions on tender participation that will be stipulated in the technical specifications, please note that EMA intends to open this procurement procedure 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.
Internal identifier : EMA/2024/OP/0013-PIN

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 80000000 Education and training services

2.1.4 General information

Additional information : This prior information notice announces the intention of the contracting authority to publish a future call for tenders. No other information or documents are available at this stage. Interested economic operators are invited to subscribe at the link https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/tender-details/3bb793a2-09dd-408e-9b8c-a6c65c5a662c-PIN in order to get notified when the contract notice and all the procurement documents, including the tender specifications, are published.
Legal basis :
Regulation (EU, Euratom) 2018/1046

3. Part

3.1 Part technical ID : PAR-0001

Title : Services to develop, design and delivery of e-learning in the field of pharmaceutical quality assessment
Description : 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. E-learning must be produced in English, French and Portuguese.

3.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 80000000 Education and training services
Additional classification ( cpv ): 79632000 Personnel-training services

3.1.3 Duration

Duration : 24 Month

3.1.5 General information

Reserved participation :
The procurement is covered by the Government Procurement Agreement (GPA) : no

3.1.6 Procurement documents

3.1.8 Techniques

Framework agreement :
Framework agreement, without reopening of competition

3.1.9 Further information, mediation and review

Review organisation : Court of Justice of the European Union

3.1 Part technical ID : PAR-0002

Title : Services to develop, design and delivery of e-learning in the field in clinical assessment
Description : 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. E-learning must be produced in English, French and Portuguese.

3.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 80000000 Education and training services
Additional classification ( cpv ): 79632000 Personnel-training services

3.1.3 Duration

Duration : 24 Month

3.1.5 General information

Reserved participation :
The procurement is covered by the Government Procurement Agreement (GPA) : no

3.1.6 Procurement documents

3.1.8 Techniques

Framework agreement :
Framework agreement, without reopening of competition

3.1.9 Further information, mediation and review

Review organisation : Court of Justice of the European Union

3.1 Part technical ID : PAR-0003

Title : Services to develop, design and delivery of e-learning in the field of non clinical assessment
Description : 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. E-learning must be produced in English, French and Portuguese.

3.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 80000000 Education and training services
Additional classification ( cpv ): 79632000 Personnel-training services

3.1.3 Duration

Duration : 24 Month

3.1.5 General information

Reserved participation :
The procurement is covered by the Government Procurement Agreement (GPA) : no

3.1.6 Procurement documents

3.1.8 Techniques

Framework agreement :
Framework agreement, without reopening of competition

3.1.9 Further information, mediation and review

Review organisation : Court of Justice of the European Union

8. Organisations

8.1 ORG-0001

Official name : European Medicines Agency, MED - European Medicines Agency
Registration number : EMEA
Postal address : Domenico Scarlattilaan 6
Town : Amsterdam
Postcode : NL-1083
Country subdivision (NUTS) : Groot-Amsterdam ( NL329 )
Country : Netherlands
Telephone : +44 20 7418 8400
Internet address : https://www.ema.europa.eu
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : Court of Justice of the European Union
Registration number : CURIA
Postal address : Rue du Fort Niedergrünewald
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 4303-1
Internet address : http://curia.europa.eu
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Commission
Registration number : EUCOM
Postal address : Mondrian (CDMA), Rue du Champ de Mars 21
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : ab772271-f553-4c79-a5b2-6230b167e90d - 01
Form type : Planning
Notice type : Prior information notice or a periodic indicative notice used only for information
Notice dispatch date : 24/01/2025 14:57 +01:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00056146-2025
OJ S issue number : 18/2025
Publication date : 27/01/2025
Estimated date of publication of a contract notice within this procedure : 11/03/2025