Notice of Call for Expressions of Interest (CEI)
1. Contracting Authority
European Medicines Agency (EMA), 30 Churchill Place, Canary Wharf, London E14 5EU, United Kingdom.
The complete documentation related to this CEI can be downloaded from EMA’s website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487
EMA wishes to establish a list of external experts to perform specific tasks related to its work, as listed in point 3 of this notice.
Information on the work of EMA can be obtained from: http://www.ema.europa.eu/ema.
Natural persons from EU Member States and EEA Countries – that will be verified by submission with the application a scan of the ID or passport - interested in having their name included on the list of external experts are invited to submit an application in accordance with the provisions set out in point 9 of this notice.
Upon examination of the applications received, EMA will draw up a list of external experts who may be invited to perform particular tasks. Inclusion on the list of experts entails no obligation on the part of EMA concerning the conclusion of contracts.
Where a particular task relating to the field described in point 3 is to be performed by an external expert, EMA will assign expert(s) to the task on the basis of the skills, experience and knowledge necessary and in accordance with the principles of non-discrimination, equal treatment and absence of conflict of interests.
3. Full description of the fields covered by the call for expressions of interest
EMA intends to cover its needs for external experts that may arise in the framework of its operational activities. The profile required is as follows:
- IT Information Security Expert:
IT Information security expertise in the domains of data classification, data retention and disposal.
Further details regarding the profile are available for download from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487.
4. Place of delivery
The tasks will be carried out at the premises designated by EMA and agreed by the expert. Where appropriate, tasks may be carried out remotely using electronic communication tools. Where necessary, further details will be specified according to the tasks and circumstances.
5. Protection of personal data
Processing a reply to the call for expressions of interest may involve the recording and processing of personal data (such as names, addresses and Curricula Vitae). Such data will be processed pursuant to Regulation (EC) No 45/2001 on the protection of individuals with regard to the processing of personal data by the European Union institutions and bodies and on the free movement of such data. Unless indicated otherwise, replies to the questions and any personal data requested are required to evaluate the application in accordance with the CEI and will be processed solely for that purpose and, if necessary, for any other relevant purposes which may be specified by the Agency. Details concerning the processing of personal data are available on the privacy statement on the Agency’s website at:
Personal data may be registered in the Early Detection and Exclusion System (EDES) if the applicant is in one of the situations mentioned in Article 106 of the Financial Regulation (Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298 of 26.10.2012, p. 1) as amended).
For more information, see the Privacy Statement at:
6. Use of the list resulting from this notice
The list resulting from this notice will be used exclusively for tasks to be within the fields described at point 3 of this CEI, with a maximum threshold of the Directive 2014/24/EU. This threshold applies to the total of all payments (including both fees and expenses) and a maximum number of 300 working days per expert throughout the entire duration for the CEI. Thus, if the ceiling is reached (or is about to be reached) the expert can no longer be assigned tasks covered by this CEI.
7. Exclusion criteria
Experts shall be excluded from participation if they are in a situation of exclusion described in Articles 106 and 107 of the Financial Regulation. Applicants interested in applying for this call for expressions of interest shall provide a signed and dated declaration of honour stating that they are not in one of the situations of exclusion listed in the declaration. The declaration can be downloaded from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487.
In case of doubt, applicants may be requested to provide supporting evidence of non-exclusion.
8. Selection criteria - professional and technical capacity:
Experts to be placed on the list shall be selected on the basis of their professional and technical capacity to perform the tasks described in this call according to the following criteria.
For the profile the following is required:
- The applicant shall be a natural person, not a legal entity.
- Bachelor’s degree in Information Security, Computer Science, Information Management Systems or 3 years of experience in a similar field.
- At least 5 years of experience working in the field of information security systems in one or more of the following domains:
- Business transformation and change;
- Information security standards;
- Data protection policies;
- Data protection operational procedures;
- Data protection registers of classified data;
- Data policy compliance checks (internal users and third party);
- Risk scenarios for optimizing security controls;
- Security controls verification and validation;
- Risk management frameworks and standards (IS027001, ISO 31000);
- EU GDPR (General Data Protection Regulations).
- Ability to negotiate with stakeholders at all levels.
- Experience in governmental organisations or similar.
Particular qualifications and skills are required for given profile and details can be downloaded from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487
EMA reserves the right to request evidence of statements in relation to selection criteria included in the on-line application form.
9. Procedure for the presentation and submission of applications:
Responses must be submitted via on-line submission form on:
Applications including all the required information may be submitted in any European Union language. However, EMA prefers to receive all documentation in English. The application should clearly indicate the profile for which the applicant wishes to apply. Applicants should also complete and submit the completed declaration upon honour for exclusion criteria (point 7) and a scan of the ID or passport and send it by email to CEIdatabase1@ema.europa.eu.
Incoming applications received in response to this CEI will be evaluated regularly; the candidates who satisfy the required exclusion and selection criteria will be pre-selected and put on a list, according to the required profiles. Successful candidates will be required to send a reference letter of the last two employers and a valid Police Certificate of Good Character or equivalent.
All applicants will be informed whether or not they are included on the list.
The draft contract which an expert would be required to sign, if awarded a contract, is available for information for download on the EMA website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487
10. Conditions of remuneration and reimbursement of experts
Experts shall be remunerated at a fixed price of EUR 250 to 450 per day worked, depending on the particular assignment. The travel and subsistence expenses will be reimbursed under the conditions set out in the contract. The experts are requested to commit themselves to respect applicable national legislation (including taxation, social security and labour laws) with regard to any payment received from EMA.
11. Expiry date of the list resulting from this call for expressions of interest
The list resulting from this notice is valid for five years from dispatch of this notice. Interested parties may submit an application at any time prior to the last three months of validity of the list.
12. Ex-post transparency
A list of experts who have signed a contract under this CEI shall be published annually on EMA’s website no later than 30 June of the year following contract award. This list shall indicate the specific task, the names of individuals, their localisation and their remuneration if it exceeds EUR 15,000 per signed contract.
13. Reference number – EMA/CEI/2018-1