Services to design, develop, and deliver 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 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 …

CPV: 80000000 Allgemeine und berufliche Bildung, 79632000 Personalschulung
Frist:
26. Mai 2025 12:00
Art der Frist:
Angebotsabgabe
Ausführungsort:
Services to design, develop, and deliver 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

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 deliver 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 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.
Procedure identifier : 3bb793a2-09dd-408e-9b8c-a6c65c5a662c
Internal identifier : EMA/2024/OP/0013
Type of procedure : Open
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

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

2.1.3 Value

Estimated value excluding VAT : 1 150 000 Euro

2.1.4 General information

Additional information : In case of unavailability or disruptions in the functioning of the electronic means of communication provided in Section 5.1.11 in the last 5 calendar days before the time limit for receipt indicated in Section 5.1.12, the contracting authority reserves the right to extend this time limit and publish the extension at the Internet address provided in Section 5.1.11, without a preceding publication of a corrigendum to this notice. Economic operators interested in this procurement are invited to subscribe to the call for tenders at the address in Section 5.1.11 in order to get notified when new information or documents are published.
Legal basis :
Regulation (EU, Euratom) 2018/1046

2.1.6 Grounds for exclusion

Bankruptcy : For the full list of exclusion grounds please consult the procurement documents.

5. Lot

5.1 Lot technical ID : LOT-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.
Internal identifier : EMA/2024/OP/0013-LOT-1

5.1.1 Purpose

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

5.1.3 Estimated duration

Duration : 24 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 12 (twelve) months, renewable 1 (one) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 375 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 56146-2025

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 26/05/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 26/05/2025 14:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

5.1 Lot technical ID : LOT-0002

Title : Services to develop, design and delivery of e-learning in the field of 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.
Internal identifier : EMA/2024/OP/0013-LOT-2

5.1.1 Purpose

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

5.1.3 Estimated duration

Duration : 24 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 12 (twelve) months, renewable 1 (one) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 400 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 56146-2025

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 26/05/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 26/05/2025 14:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

5.1 Lot technical ID : LOT-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.
Internal identifier : EMA/2024/OP/0013-LOT-3

5.1.1 Purpose

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

5.1.3 Estimated duration

Duration : 24 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 12 (twelve) months, renewable 1 (one) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 375 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 56146-2025

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 26/05/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 26/05/2025 14:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 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
Notice information
Notice identifier/version : be0303e9-0639-4e52-94f3-c991fa3d538a - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 15/04/2025 10:39 +02:00
Languages in which this notice is officially available : English
Notice publication number : 00249869-2025
OJ S issue number : 75/2025
Publication date : 16/04/2025