Section I: Contracting authority
I.1)Name and addressesOfficial name: European Medicines Agency (EMA)
Postal address: PO Box 71010
Town: Amsterdam
NUTS code: NL329 Groot-Amsterdam
Postal code: 1008 BA
Country: Netherlands
E-mail: Procurement@ema.europa.eu
Internet address(es):
Main address: https://www.ema.europa.eu/
Address of the buyer profile: https://www.ema.europa.eu/en/about-us/procurement
I.3)CommunicationThe procurement documents are available for unrestricted and full direct access, free of charge, at: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=10491
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted electronically via: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=10491
Tenders or requests to participate must be submitted to the abovementioned address
I.4)Type of the contracting authorityEuropean institution/agency or international organisation
I.5)Main activityGeneral public services
Section II: Object
II.1)Scope of the procurement
II.1.1)Title:Reference number: EMA/2021/13/TDA
II.1.2)Main CPV code80510000 Specialist training services
II.1.3)Type of contractServices
II.1.4)Short description:
The European Medicines Agency (EMA) is seeking to sign multiple framework contracts in three different lots for developing a Big Data Curriculum to enhance the skills of the EU regulatory network. The Big Data curriculum is composed of the Data Science curriculum, Pharmacoepidemiology and Real-world evidence curriculum, Biostatistics and Clinical Trial Methodology curriculum and modules in the field of clinical trials. The contractors will develop trainings in these fields that will ensure the provision of first-rate trainings and enable regulators to apply the acquired knowledge in regulatory activities.
II.1.5)Estimated total valueValue excluding VAT: 900 000.00 EUR
II.1.6)Information about lotsThis contract is divided into lots: yes
Tenders may be submitted for all lots
II.2)Description
II.2.1)Title:
Development and Delivery of Trainings for the Data Science Curriculum
Lot No: 1
II.2.2)Additional CPV code(s)80510000 Specialist training services
73000000 Research and development services and related consultancy services
II.2.3)Place of performanceNUTS code: NL329 Groot-Amsterdam
Main site or place of performance:
II.2.4)Description of the procurement:
See internet address provided in Section I.3).
II.2.5)Award criteriaPrice is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)Estimated valueValue excluding VAT: 280 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 12
This contract is subject to renewal: yes
Description of renewals:
The contract will be concluded for an initial period of one year with the possibility of three renewals each of one year (maximum contract duration is four years).
II.2.10)Information about variantsVariants will be accepted: no
II.2.11)Information about optionsOptions: no
II.2.13)Information about European Union fundsThe procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
See internet address provided in Section I.3).
II.2)Description
II.2.1)Title:
Development and Delivery of Trainings for the Pharmacoepidemiology and Real-world Evidence Curriculum
Lot No: 2
II.2.2)Additional CPV code(s)80420000 E-learning services
73000000 Research and development services and related consultancy services
II.2.3)Place of performanceNUTS code: NL329 Groot-Amsterdam
Main site or place of performance:
II.2.4)Description of the procurement:
See internet address provided in Section I.3).
II.2.5)Award criteriaPrice is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)Estimated valueValue excluding VAT: 280 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 12
This contract is subject to renewal: yes
Description of renewals:
The contract will be concluded for an initial period of one year with the possibility of three renewals each of one year (maximum contract duration is four years).
II.2.10)Information about variantsVariants will be accepted: no
II.2.11)Information about optionsOptions: no
II.2.13)Information about European Union fundsThe procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
See internet address provided in Section I.3).
II.2)Description
II.2.1)Title:
Development and Delivery of Trainings for the Biostatistics and Clinical Trial Methodology Curriculum and Development and Delivery of Modules in the Field of Clinical Trials
Lot No: 3
II.2.2)Additional CPV code(s)80420000 E-learning services
73000000 Research and development services and related consultancy services
II.2.3)Place of performanceNUTS code: NL329 Groot-Amsterdam
Main site or place of performance:
II.2.4)Description of the procurement:
See internet address provided in Section I.3).
II.2.5)Award criteriaPrice is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)Estimated valueValue excluding VAT: 340 000.00 EUR
II.2.7)Duration of the contract, framework agreement or dynamic purchasing systemDuration in months: 12
This contract is subject to renewal: yes
Description of renewals:
The contract will be concluded for an initial period of one year with the possibility of three renewals each of one year (maximum contract duration is four years).
II.2.10)Information about variantsVariants will be accepted: no
II.2.11)Information about optionsOptions: no
II.2.13)Information about European Union fundsThe procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
See internet address provided in Section I.3).
Section III: Legal, economic, financial and technical information
III.1)Conditions for participation
III.1.1)Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registersList and brief description of conditions:
See internet address provided in Section I.3).
III.1.2)Economic and financial standingSelection criteria as stated in the procurement documents
III.1.3)Technical and professional abilitySelection criteria as stated in the procurement documents
III.2)Conditions related to the contract
III.2.2)Contract performance conditions:
See internet address provided in Section I.3).
Section IV: Procedure
IV.1)Description
IV.1.1)Type of procedureOpen procedure
IV.1.3)Information about a framework agreement or a dynamic purchasing systemThe procurement involves the establishment of a framework agreement
Framework agreement with several operators
Envisaged maximum number of participants to the framework agreement: 2
IV.1.8)Information about the Government Procurement Agreement (GPA)The procurement is covered by the Government Procurement Agreement: no
IV.2)Administrative information
IV.2.2)Time limit for receipt of tenders or requests to participateDate: 31/05/2022
Local time: 12:00
IV.2.3)Estimated date of dispatch of invitations to tender or to participate to selected candidates
IV.2.4)Languages in which tenders or requests to participate may be submitted:English, Bulgarian, Danish, German, Greek, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Latvian, Lithuanian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish, Czech
IV.2.6)Minimum time frame during which the tenderer must maintain the tenderDuration in months: 9 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tendersDate: 01/06/2022
Local time: 14:00
Place:
Domenico Scarlattilaan 6, 1083 HS Amsterdam, THE NETHERLANDS.
Information about authorised persons and opening procedure:
See Internet address provided in Section I.3).
Section VI: Complementary information
VI.1)Information about recurrenceThis is a recurrent procurement: no
VI.3)Additional information:
See internet address provided in Section I.3).
VI.4)Procedures for review
VI.4.1)Review bodyOfficial name: General Court
Postal address: rue du Fort Niedergrünewald
Town: Luxembourg
Postal code: L-2925
Country: Luxembourg
E-mail: generalcourt.registry@curia.europa.eu
Telephone: +352 4303-1
Fax: +352 4303-2100
Internet address: http://curia.europa.eu
VI.4.3)Review procedurePrecise information on deadline(s) for review procedures:
See internet address provided in Section I.3).
VI.4.4)Service from which information about the review procedure may be obtainedOfficial name: European Medicines Agency (EMA)
Postal address: PO Box 71010
Town: Amsterdam
Postal code: 1008 BA
Country: Netherlands
E-mail: info@ema.europa.eu
Telephone: +31 88781600
Internet address: https://www.ema.europa.eu
VI.5)Date of dispatch of this notice:06/04/2022