Invitation

Ref. Ares(2023)3107203 - 03/05/2023 EUROPEAN COMMISSION 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?  1. Introduction The European Commission (hereafter ‘the 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 of 23 October 2018 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, 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. This privacy statement concerns the processing operation Organisation and management of Commission expert group meetings undertaken by the European Commission, DG SANTE (Health and Food Safety) / Unit D2 – Medical Products: quality, safety, innovation as presented below. For the purpose of this privacy statement and the corresponding record, the term “expert groups” describes Commission expert groups in the sense of Article 2(1) of Commission Decision C(2016)3301 of 30 May 20161 and their sub-groups, as well as other similar entities in the sense of Article 2(2) of Commission Decision C(2016)3301 and their sub-groups. 2. Why and how do we process your personal data? Purpose of the processing operation: The European Commission collects and uses your personal information only for the organisation, preparation, management and follow-up of expert groups meetings. More specifically, this concerns the following processing activities: • communication activities such as sending e-mails and invitations (this entails the management of contact lists for correspondence); • exchange of meeting documents (notably through information sharing and circulation of documents via e-mail, the Advanced Gateway to EU Meetings (AGM) online system for meeting organisation (see Record of processing DPR-EC-01141 - Information system supporting the organisation of meetings (former notification DPO-3911)) or CIRCABC (see Record of Processing DPR-EC-01666 - CIRCA and CIRCABC – Global User Directory)) and sharing of information with other Commission services to follow-up on the expert group meeting concerned; • discussion among the participants in the expert group: in certain cases, the participants in the expert group need to know each other’s names and contact details, so that they can discuss topics on the agenda of the meetings before or after the meetings. • organisational and administrative activities to ensure the participants' access to Commission premises (see Record of Processing DPR-EC-00655 (Commission Physical Access Control System (PACS))); • reimbursement of travel, subsistence costs or payment of special allowances in the sense of Article 21 of Commission decision C(2016) 3301 (see Record of Processing DPR- EC-00301 - Legal Entities and Bank Accounts); • audio-visual recording of the meetings for the purpose of drafting minutes (see Records of Processing DPR-EC-0193703266 (Audio-visual recording of meetings) and DPR-EC- 1 Commission Decision C(2016)3301 of 30 May 2016 establishing horizontal rules on the creation and operation of Commission expert groups. 2  03266 (Audio and Audio -Visual Recording of meetings requested via the Commission's internal Room Booking system)); • if meeting is held virtually: for meetings held virtually, use of a webconferencing service, including recording of the meeting and use of the information exchanged in the chat function for the purpose of drafting minutes of the meeting (more information on the processing of personal data for technical and billing purposes is provided in the dedicated record of processing of the webconferencing service used, namely for Skype for Business DPR-EC-02548; for Teams DPR-EC-04966; for WebEx DPR-EC-05006.]; • publication of minutes of meetings, including list of participants, in the Register of Commission expert groups and other similar entities (‘the Register of expert groups’) for reasons of transparency. The minutes and the list of participants include the names of individuals appointed as members either in a personal capacity who are due to act independently and in the public interest, or to represent a common interest shared by stakeholders in a particular policy area, as well as of individuals invited as experts to take part in the work of the group on ad hoc basis. The minutes may also include the positions of these individuals as expressed at the meeting. In the case of organisations, Member States’ authorities and other public entities, the names of their representatives may only be included in the minutes and published in the Register of expert groups subject to their prior freely given, specific, informed and unambiguous consent, in compliance with Article 3(15) and Article 7 of Regulation (EU) 2018/1725. Furthermore, in agreement with the competent Commission department, the expert group may, by simple majority of its members, decide that deliberations shall be public, in compliance with Article 13.6 of Commission Decision C(2016)3301 of 30 May 2016 establishing horizontal rules on the creation and operation of Commission expert groups. If during the virtual meeting, the organiser records the speakers, you will be informed by an alert on your screen when the recording is taking place. The recording will be used for internal purposes only to enable accurate minute taking. Also any information exchanged in the chat function may be used for the preparation of minutes. Personal data may be stored in the Commission’s document management system (for further information on the Commission’s document management system please refer to the processing operation ‘Management and (short- and medium-term) preservation of Commission documents`, reference number: DPR-EC-00536). Your personal data will not be used for an automated decision-making including profiling. 3. On what legal ground(s) do we process your personal data We process your personal data, because processing is necessary for the performance of a task carried out in the public interest (Article 5(1)(a) of Regulation (EU) No 2018/1725). Expert groups play an important role in enabling the Commission to collect advice and views from a variety of key actors, such as Member States' authorities, private stakeholders, scientists and professionals. The Commission uses advice and expertise received as a basis for sound policy making and implementation. The natural way for the Commission to obtain the opinion of the expert groups is in meetings. Furthermore, preparing minutes of the meetings of expert groups allows for the proper documentation of the work of the expert groups and also increases the transparency on expert groups and their work. Processing of your personal data is also necessary to comply with a legal obligation to which the controller is subject (Article 5(1)(b) of Regulation (EU) No 2018/1725), namely Commission Decision C(2016)3301 of 30 May 2016 establishing horizontal rules on the creation and operation of Commission expert groups, and in particular its Articles 13, 20 and 26. The latter Commission Decision also constitutes the Union law on which the processing under Article 5(1)(a) and (b) of Regulation (EU) No 2018/1725 is based. For specific processing activities the consent of the data subject is necessary: The names of representatives of organisations, Member States’ authorities and other public entities are included in the minutes of the meetings only subject to their prior freely given, specific, informed and unambiguous consent, in compliance with Article 3(15) and Article 7 of Regulation (EU) No 2018/1725. In some cases, it may not be necessary for participants in expert groups to have each other’s names and contact details so that they can participate, prepare and follow-up on meetings, and in those cases such personal data will be shared based on the consent of the data subjects. Your consent is required for the processing of your personal data relating to your dietary requirements and/or access requirements. If you opt-in, you are giving us your explicit consent under Article 5(1)(d) of Regulation (EU) 2018/1725 to process your personal data for those specific purposes. You can give your consent form by informing the controller for the expert group in question. You can withdraw your consent for these services at any time by contacting the controller for the expert group in question. 4. Which personal data do we collect and further process? In order to carry out this processing operation the Data Controller may collect the following categories of personal data: ▪ Personal data necessary for organising and managing meetings such as gender (Mr/Ms), name, organisation to which he/she belongs, e-mail address, phone/fax number; ▪ Personal data necessary for security (access control to Commission premises) such as ID card/Passport number and date of birth, name, surname, organisation he/she belongs to, gender; ▪ Personal data included in the minutes of meetings, such as names of meeting participants and their positions expressed (in case of representatives of organisations, Member States’ authorities and other public entities, only based on their prior freely given, specific, informed and unambiguous consent, if at all); ▪ Personal data necessary for establishing the attendance list and the minutes: signature, audio-visual recording of the meeting; [if applicable: ▪ Personal data processed for web-streaming of the meeting, including audio-visual recording of the meeting ▪ Personal data necessary for reimbursements purposes such as name, means of transport, hotel accommodation and banking details; 4 ▪ Personal data necessary for payment of special allowances, such as name and banking details ▪ Personal data relating to your dietary requirements and/or access requirements ▪ Personal data collected during meetings held virtually ▪ via a webconferencing service: recording of the meeting, information exchanged in the chat function of meetings held virtually, as well as technical and connection data that make it possible to use the webconferencing service Except for the personal data relating to your dietary requirements and/or access requirements, whose processing is based on your explicit consent, the provision of the above-mentioned personal data is mandatory in order to allow for the organisation of, and participation in the meeting, the access of participants to Commission premises and their reimbursement. If you do not provide these personal data, possible consequences are the impossibility to attend meetings and/or to be reimbursed or paid. We have obtained your personal data either directly from you, via the competent National department, other public entity or organisation that you work for or via the Permanent Representation of your country in Brussels. 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, namely for a maximum of 5 years after closure of the file to which the personal data processed belongs. The documents related to the work of the expert groups are transferred to the Historical Archives for permanent preservation2. The ‘administrative retention period’ of five years is based on the retention policy of Commission documents and files (and the personal data contained in them), governed by the common Commission-level retention list for European Commission files (SEC(2019)900). It is a regulatory document in the form of a retention schedule that establishes the retention periods for different types of Commission files. That list has been notified to the European Data Protection Supervisor. The ‘administrative retention period’ is the period during which the Commission departments are required to keep a file depending on its usefulness for administrative purposes and the relevant statutory and legal obligations. This information is without prejudice to different retention periods which may apply to personal data processed for the purpose of reimbursing travel and subsistence costs, payment of special allowances, ensuring the participant's access to Commission premises and technical processing for of a webconferencing service, in accordance with the dedicated processing operations notified to the DPO by the responsible Commission departments (Records of Processing DPR-EC- 00655 (Commission Physical Access Control System (PACS)), DPR-EC-00301 - Legal Entities and Bank Accounts) specifc records of webconferencing services (for Skype for Business DPR-EC- 02548; for Teams DPR-EC-04966; for WebEx DPR-EC-05006. 2 For further information about the processing operations concerning the Historical Archives, please Record of processing 'Management and long-term preservation of the European Commission's Archives’, registered under reference number DPR-EC-00837. Sensitive personal data relating to dietary and/or access requirements will be deleted as soon as they are no longer necessary for the purpose for which they have been collected in the framework of the expert group meeting, but no later than within 1 month after the end of the meeting. Recordings from the web-streamed meeting will be kept for 2 years before being deleted. More information is available in the Record of Processing DPR-EC-00306 (Web-streaming of Commission events). In case of audio-visual recording of the meeting, the recordings will be kept for 3 months after the meeting before being deleted. More information is available in the Record of Processing DPR-EC-03266 (Audio-visual recording of meetings). 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 (or of its contractors (processors), if contractors are engaged to assist the controller). All processing operations are carried out pursuant to the 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. If the controller uses (a) contractor(s) (processor(s)) to assist the controller, this will be indicated in the specific privacy statement and the following paragraph will be provided: The Commission’s processors (contractors) are bound by a specific contractual clause for any processing operations of your personal data on behalf of the Commission. The processors have to put in place appropriate technical and organisational measures to ensure the level of security, required by the Commission. 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 authorised 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. More specifically, the following Commission staff have access to certain parts of the personal data: 6  - Authorised staff of the European Commission's Directorate-General for Human Resources and Security have access to the personal data necessary for providing access to European Commission premises; - Authorised staff of the European Commission's Directorate-General for Budget and the Paymaster Office (PMO) have access to the personal data needed for reimbursement purposes and payment of special allowances; - Authorised staff of the European Commission's Directorate-General for Interpretation (SCIC) as meeting room and equipment providers have access to the audio-visual recordings of the meetings; - Authorised staff of other European Commission departments involved in the policy follow-up to a specific expert group meeting. Furthermore, professional contact details of representatives may be shared with other representatives of the same expert group if necessary for the organisation, preparation, management or follow-up of meetings The minutes of expert group meetings are made public on the Register of expert groups. Please note that pursuant to Article 3(13) of Regulation (EU) 2018/1725, public authorities (e.g. Court of Auditors, EU Court of Justice, European Ombudsman) which may receive personal data in the framework of a particular inquiry in accordance with Union or Member State law shall not be regarded as recipients. The further processing of those data by those public authorities shall be in compliance with the applicable data protection rules according to the purposes of the processing. The information we collect will not be given to any third party, except to the extent and for the purpose we may be required to do so by law. 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 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. When you visit the website(s) of our meeting and when you register, we will keep the browser history of your visit for a maximum of 13 months. This information will then be deleted. The collection, aggregation and anonymising operations are performed in the data centre of the European Commission under adequate security measures. 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 at https://ec.europa.eu/info/privacy-policy/europa-analytics_en. 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 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), as well as Articles 35 and 36 of Regulation (EU) 2018/1725, in particular the right to access your personal data and to rectify them in case your personal data is inaccurate or incomplete. Under certain conditions, 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. Insofar the processing of your personal data is based on your consent (namely concerning dietary and access requirements, the publication or sharing of your personal data in certain cases), you can withdraw your consent at any time by notifying the Data Controller. The withdrawal 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. Data subject requests shall be handled within one month from receipt of the request by the Commission. That period may be extended pursuant to 14(3) of Regulation (EU) 2018/1725. Should more time be required to handle the request for justified reasons, the data subject shall receive a holding reply from the de facto operational controller responsible for the 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 8 - 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 Commission, which have been documented and notified to him. You may access the register via the following link: http://ec.europa.eu/dpo-register. This specific processing operation has been included in the DPO’s public register with the following Record reference: DPR-EC-00744. Ref. Ares(2023)6697196 - 03/10/2023 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 Competent Authorities on Substances of Human Origin Expert Group (CASoHO E01718) Joint Meeting of the Competent Authorities on: Blood and Blood Components Tissues and Cells Organs 18 October 2023, 09:00 - 13:00 BRUSSELS Virtual event AGENDA Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111  1. Welcome, introductory remarks and adoption of the agenda 2. Regulatory matters: Points for information / discussion 2.1 Proposal for new EU legislations on SoHO and on pharmaceuticals - updates 2.2 Implementing the EU SOHO legislation - Update IES activities - Update VES activities 2.3 Cooperation EDQM-ECDC in the new SoHO regulation 2.4 EU SoHO platform 3. Presentations on EU-funded activities 3.1 EU-funded activities to support the implementation of the new SoHO Regulation - Coordination of (new) hospital SoHO activities - entities (NTT) - Implementation of SoHO regulation for new SoHO (FMT, BM) - Preparation authorisation: GAPP-PRO (ISS/IT) - Training staff authorities: SIGHT-SOHO (ISS/IT) 3.2 Other Coffee break Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111  4. WHO Update 5. ECDC Update 6. EMA Update 7. Council of Europe EDQM Update 8. Any Other Business 9. Final Remarks 3 Electronically signed on 03/10/2023 13:01 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121 Joint Meeting of the Competent Authorities on: Blood and Blood Components, Tissues and Cells, Organs Hosted by SANTE CONSULT D2 https://ecconf.webex.com/ecconf/j.php?MTID=m1f2542912ed99c5ef231c327fc6f2e83 Wednesday, October 18, 2023 9:00 AM | 4 hours | (UTC+02:00) Brussels, Copenhagen, Madrid, Paris Meeting number: 2742 705 4304 Password: tPFqGpk*527 (87374750 from phones) Agenda: Join by video system Dial [email protected] You can also dial 62.109.219.4 and enter your meeting number. Join by phone +32-262-00867 Belgium Toll +352-2730-0072 Luxembourg Toll Access code: 274 270 54304 Ref. Ares(2023)6697196 - 03/10/2023 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 TO THE MEMBERS OF THE NATIONAL COMPETENT AUTHORITIES FOR: BLOOD and BLOOD COMPONENTS TISSUES and CELLS ORGAN DONATION and TRANSPLANTATION Subject: Invitation to the Joint Virtual Meeting of the National Competent Authorities on 18 October 2023 Dear Colleagues, We are pleased to invite you to the joint virtual meeting of the National Competent Authorities for Blood and Blood Components, Tissues and Cells, Organ Donation and Transplantation on 18 October 2023 from 09.00 to 13.00 (CET). Please find attached the draft agenda for the meeting. The information to join the teleconference are also attached. When joining the teleconference and prompted to do so, please spell out your First Name, your Name, and your Affiliation (no acronyms/initials, no nicknames please). If you have any question, do not hesitate to contact [email protected]. Yours faithfully, Sylvain GIRAUD D2 Head of Unit Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 Electronically signed on 03/10/2023 13:01 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121 Saatja: <[email protected]> Saadetud: 05.10.2023 15:42 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: Joint Blood, Tissues & Cells and Organs NCA Virtual Meeting 18 October 2023 Manused: image001.jpg; Agenda Joint BTCO meeting 18Oct23 for ARES v2.pdf; Invitation letter Joint BTCO meeting 18Oct23.pdf; WebEx Joining Details 18 Oct 23.pdf; Expert group meetings_Privacy statement_00744.pdf Dear Colleagues, We are pleased to invite you to the joint virtual meeting of the National Competent Authorities for Blood, Tissues & Cells and Organs on Wednesday 18 October 2023 from 09.00 to 13.00 (CET). A coffee break is foreseen. 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