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Ref. Ares(2023)5216824 - 27/07/2023 EUROPEAN COMMISSION PROTECTION OF YOUR PERSONAL DATA This privacy statement provides information about the processing and the protection of your personal data. Processing operation: Organisation and management of meetings of expert groups Data Controller: European Commission, DG SANTE (Health and Food Safety) / Unit D2 – Medical Products: quality, safety, innovation Record reference: DPR-EC-00744 Table of Contents 1. Introduction 2. Why and how do we process your personal data? 3. On what legal ground(s) do we process your personal data? 4. Which personal data do we collect and further process? 5. How long do we keep your personal data? 6. How do we protect and safeguard your personal data? 7. Who has access to your personal data and to whom is it disclosed? 8. What are your rights and how can you exercise them? 9. Contact information 10. Where to find more detailed information? Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 1. Introduction The European Commission is committed to protect your personal data and to respect your privacy. The Commission collects and further processes personal data pursuant to Regulation (EU) 2018/1725 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data. This privacy statement explains the reason for the processing of your personal data in the context of National Competent Authorities meeting. It explains the way we collect, handle and ensure protection of all personal data provided, how that information is used and what rights you have in relation to your personal data. It also specifies the contact details of the responsible Data Controller with whom you may exercise your rights, the Data Protection Officer and the European Data Protection Supervisor. The information in relation to processing operation for the National Competent Authorities meeting, undertaken by DG SANTE (Health and Food Safety) / Unit D2 – Medical Products: quality, safety, innovation of the European Commission, is presented below. 2. Why and how do we process your personal data? Purpose of the processing operation: The European Commission collects and further processes your personal data to provide you with information about the National Competent Authorities meeting (before, during and after) and to process your application for participation in that National Competent Authorities meeting. Your personal data will not be used for any automated decision-making including profiling. 3. On what legal ground(s) do we process your personal data? The processing operations on personal data, linked to the organisation, management, follow-up and promotion of the National Competent Authorities meeting (including web-streaming, photos, audio-visual recording) are necessary for the management and functioning of the Commission, as mandated by the Treaties. Those provisions are in particular Article 15 of the Treaty on the Functioning of the European Union. Consequently, those processing operations are lawful under Article 5(1)(a) of Regulation (EU) 2018/1725 (processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the Union institution or body). 4. Which personal data do we collect and further process? The following personal data will be processed:  contact details (function/title, first name, last name, name of organisation, city, country, e-mail address, telephone number);  nationality, passport or identity card number and its date of issue and expiry date may be collected, so that the data subjects may obtain access to the premises where the meeting/event is held; 2   financial information (such as a payment card number or bank account) may be collected for the payment of fees of the meeting/event or for possible reimbursements. 5. How long do we keep your personal data? The Data Controller only keeps your personal data for the time necessary to fulfil the purpose of collection or further processing. For each of the categories of personal data that is processed, please find below the retention details and the reference to the relevant record of processing:  All personal data related to the organisation and management of the National Competent Authorities meeting (this includes the information given during the registration, before, during or after the event) will be deleted one year after the last action in relation to the National Competent Authorities meeting.  Personal data shared with the Directorate-General for Human Resources and Security of the European Commission for the participants to gain access to Commission buildings is kept for 6 months after the termination of the link between the data subject and the Commission. More information is available in the Record of Processing DPR-EC-00655 (Commission Physical Access Control System (PACS)). 6. How do we protect and safeguard your personal data? All personal data in electronic format (e-mails, documents, databases, uploaded batches of data, etc.) are stored on the servers of the European Commission. All processing operations are carried out pursuant to Commission Decision (EU, Euratom) 2017/46 of 10 January 2017 on the security of communication and information systems in the European Commission. In order to protect your personal data, the Commission has put in place a number of technical and organisational measures. Technical measures include appropriate actions to address online security, risk of data loss, alteration of data or unauthorised access, taking into consideration the risk presented by the processing and the nature of the personal data being processed. Organisational measures include restricting access to the personal data solely to authorised persons with a legitimate need to know for the purposes of this processing operation. 7. Who has access to your personal data and to whom is it disclosed? Access to your personal data is provided to the Commission staff responsible for carrying out this processing operation and to other authorised Commission staff according to the “need to know” principle. Such staff abide by statutory, and when required, additional confidentiality agreements. Cookies Cookies are short text files stored on a user’s device (such as a computer, tablet or phone) by a website. Cookies are used for the technical functioning of a website (functional cookies) or for gathering statistics (analytical cookies). The registration for the National Competent Authorities meeting takes place via a Commission website. The cookies employed by the Commission on the registrant’s device for that purpose will be covered by the cookie policy of the Commission, which is available here: https://ec.europa.eu/info/cookies_en. 3 Cookies are stored by Europa Analytics, the corporate service which measures the effectiveness and efficiency of the European Commission's websites on EUROPA. More information is available in the Record of Processing DPR-EC-00685 (Europa Analytics). Enabling these cookies is not strictly necessary for the website to work but it will provide you with a better browsing experience. You can delete or block these cookies, but if you do that, some features of the meeting/event website may not work as intended. The cookie-related information is not used to identify data subjects personally and the pattern data is fully under the Commission’s control. These cookies are not used for any purpose other than those described here. Should you wish to opt your personal data out of our anonymised, aggregated statistics, you can do so on our cookies page. In particular, you can control and/or delete those cookies as you wish. 8. What are your rights and how can you exercise them? You have specific rights as a ‘data subject’ under Chapter III (Articles 14-25) of Regulation (EU) 2018/1725, in particular the right to access, your personal data and to rectify them in case your personal data are inaccurate or incomplete. Where applicable, you have the right to erase your personal data, to restrict the processing of your personal data, to object to the processing, and the right to data portability. You have the right to object to the processing of your personal data, which is lawfully carried out pursuant to Article 5(1)(a) of Regulation (EU) 2018/1725 on grounds relating to your particular situation. You have consented to provide your personal data to the data controller for the present processing operation. You can withdraw your consent at any time by notifying the data controller via email as soon as the meeting is concluded. The withdrawal of your consent will not affect the lawfulness of the processing carried out before you have withdrawn the consent. You can exercise your rights by contacting the data controller, or in case of conflict the Data Protection Officer. If necessary, you can also address the European Data Protection Supervisor. Their contact information is given under Heading 9 below. Where you wish to exercise your rights in the context of one or several specific processing operations, please provide their description (i.e. their Record reference(s) as specified under Heading 10 below) in your request. 9. Contact information - The Data Controller If you would like to exercise your rights under Regulation (EU) 2018/1725, or if you have comments, questions or concerns, or if you would like to submit a complaint regarding the collection and use of your personal data, please feel free to contact the Data Controller, European Commission, DG SANTE (Health and Food Safety) / Unit D2 – Medical Products: quality, safety, innovation at [email protected]. 4 - The Data Protection Officer (DPO) of the Commission You may contact the Data Protection Officer ([email protected]) with regard to issues related to the processing of your personal data under Regulation (EU) 2018/1725. - The European Data Protection Supervisor (EDPS) You have the right to have recourse (i.e. you can lodge a complaint) to the European Data Protection Supervisor ([email protected]) if you consider that your rights under Regulation (EU) 2018/1725 have been infringed as a result of the processing of your personal data by the data controller. 10. Where to find more detailed information? The Commission Data Protection Officer (DPO) publishes the register of all processing operations on personal data by the European Commission, which have been documented and notified to him. You may access the register via the following link: http://ec.europa.eu/dpo- register. 5 Ref. Ares(2023)5216824 - 27/07/2023 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems, medical products and innovation Medical products: quality, safety, innovation Brussels SANTE.DDG1.D.2/MA/ARES (2023) Competent Authorities on Substances of Human Origin Expert Group (CASoHO E01718) Joint Meeting of the Competent Authorities for Blood & Blood Components and Tissues &Cells 31 August 2023 09:30 – 12:00 (CET) TELECONFERENCE DRAFT AGENDA Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 1. WELCOME, INTRODUCTORY REMARKS AND ADOPTION OF THE AGENDA 2. SCOPE OF THE EU SOHO PLATFORM 3. SUPPORTING CONTRACTS 3.1. Feasibility study (completed) 3.2. DG DIGIT UX lab activities (completed) 3.3. Pre-analysis on business need (completed) 3.4. Implementation phase (DG SANTE staff recruiting on-going) 4. MAPPING OF EXISTING SOHO RELATED IT PLATFORM AT NATIONAL LEVEL 5. NEXT STEPS 6. QUESTIONS & ANSWERS 7. FINAL REMARKS PLEASE NOTE THAT ALL SUPPORTING DOCUMENTS WILL BE SENT TO YOU VIA THE CIRCABC SITE BEFORE THE MEETING. 2 Ref. Ares(2023)5216824 - 27/07/2023 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Medical Products and Innovation Medical Products: Quality, Safety, Innovation Brussels SANTE.D.2/MA Dear National Authorities for blood & blood components and for tissues & cells, We are pleased to invite you to a virtual meeting to update you on the status of the development of the EU SoHO platform on Thursday 31 August 2023 from 09.30 to 12.00 (CET). A coffee break is foreseen. As you know, the EU SoHO platform will support and facilitate the effective and efficient exchange of information concerning SoHO activities in the Union. Our team is committed to deliver an instrument which will be useful and fit for purpose, building on the experience gained with currently existing IT tools. This meeting will be an opportunity to summarise what has been done so far, outline the next steps and highlight the role of the Competent Authorities, in particular those of you who volunteered to provide additional feedback, in the whole development process. We would like to inform you that the Health Attachés are in copy of this email and are invited to attend as well. When joining the event and prompted to do so, please clearly write your Name, Surname and Affiliation (please: no nicknames, no acronyms). If you have any question, do not hesitate to contact [email protected]. Yours faithfully, The SoHO Team Enclosures: - the draft agenda for the meeting. - the call-in details to connect to the conference call via Webex. - the privacy statement Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111 Saatja: <[email protected]> Saadetud: 27.07.2023 15:50 Adressaat: <[email protected]> Koopia: AMBROSIO Massimo <[email protected]>; FEHILY Deirdre <[email protected]>; MARQUEZ-GARRIDO Beatrice <Beatrice.MARQUEZ- [email protected]>; VAN DER SPIEGEL Stefaan <Stefaan.VAN-DER- [email protected]> Teema: Invitation to a joint virtual meeting of blood and tissues & cells competent authorities on the development of the EU SoHO Platform – 31 August AM Manused: image001.jpg; Privacy_personal-data_NCA meetings ARESd.pdf; Invitation letter ARESd.pdf; 20230831 Agenda NCA Blood and T&C Joint meeting - draft ARESd.pdf; WebEx Joining Details.pdf Dear National Authorities for blood & blood components and for tissues & cells, We are pleased to invite you to a virtual meeting to update you on the status of the development of the EU SoHO platform on Thursday 31 August 2023 from 09.30 to 12.00 (CET). A coffee break is foreseen. As you know, the EU SoHO platform will support and facilitate the effective and efficient exchange of information concerning SoHO activities in the Union. Our team is committed to deliver an instrument which will be useful and fit for purpose, building on the experience gained with currently existing IT tools. This meeting will be an opportunity to summarise what has been done so far, outline the next steps and highlight the role of the Competent Authorities, in particular those of you who volunteered to provide additional feedback, in the whole development process. We would like to inform you that the Health Attachés are in copy of this email and are invited to attend as well. Please find attached: - The invitation letter - the draft agenda for the meeting - the call in details to connect to the conference call via Webex - the privacy statement When joining the event and prompted to do so, please write clearly your Name, Surname and Affiliation (please: no nicknames, no acronyms). If you have any question, do not hesitate to contact [email protected]. Yours faithfully, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit D2 – Medical Products: quality, safety, innovation Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm When it's time, join the Webex meeting here. Need help? Go to https://help.webex.com Join meeting More ways to join: Join from the meeting link https://ecconf.webex.com/ecconf/j.php?MTID=md6c78b04dc287ab5923e094ad1d78456 Join by meeting number Meeting number (access code): 2742 507 6607 Meeting password: 2qpC6TfAP3? (27726832 from phones) Tap to join from a mobile device (attendees only) +32-262-00867,,27425076607#27726832# Belgium Toll +352-2730-0072,,27425076607#27726832# Luxembourg Toll Some mobile devices may ask attendees to enter a numeric password. Join by phone +32-262-00867 Belgium Toll +352-2730-0072 Luxembourg Toll Global call-in numbers Join from a video system or application Dial [email protected] You can also dial 62.109.219.4 and enter your meeting number.