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Saatja: [email protected] Saaja: [email protected], [email protected] Teema: Round 2 SIGHTSoHO eLearning Training: application procedure is open! Kuupäev: 2024-12-04 17:12 Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Competent Authorities for blood, tissues, cells and organs, Following up the Save-the-Date message for Round 2 SIGHTSoHO eLearning Training , we are pleased to inform you that the application procedure is now open until December 20th, 2024 (23:59 CET) at the following link: SIGHTSoHO Round 2 APPLICATION FORM IMPORTANT: As anticipated, in order to finalise your application, please bear in mind that you are required to provide a formal commitment (as explained in the online training information sheet) to attend the training modules for which you have expressed interest within one week from the submission of the application, otherwise your place will be reallocated to another applicant. The note of commitment, herewith attached in word and PDF, will have to be signed also by the Competent Authority or your direct responsible person in order to allow participation without restrictions. For further details on the training, including selection criteria, please find herewith attached the dedicated Information Sheet. If you need more info, please contact the SIGHTSoHO Team at [email protected]. Best regards, 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 From: SANTE SOHO Sent: Thursday, November 28, 2024 2:47 PM To: SANTE SOHO <[email protected]> Cc: SANTE DL SOHO <[email protected]>; Pupella Simonetta <[email protected]>; Palmieri Anna <[email protected]>; Denaro Ivan <[email protected]>; Di Ciaccio Paola <[email protected]>; Gentile Margherita <[email protected]>; Claudia Carella <[email protected]>; maura mareri <[email protected]>; BINDER Alexander (HADEA) <[email protected]> Subject: Upcoming Call for Expression of Interest: Round 2 SIGHTSoHO eLearning Training Dear Competent Authorities, Get ready! We are pleased to inform you that the application procedure for Round 2 SIGHTSoHO eLearning training will be opening next week. Given the tight timeline, the application period will close on December 20th, 2024, at 23:59 CET. As the holiday season is approaching, we kindly request that you share this message with your networks to ensure that interested participants can start planning and be ready to respond quickly when the official call is launched. To ensure a smooth application process, please note that you will be required to provide a formal commitment to attend from both the participants wishing to join the training modules for which they have expressed interest and from the Competent Authority or direct responsible of the applicants, to allow participation without restrictions. Below, we would like to pre-announce the training dates for your information and planning purposes: Round 2 SIGHTSoHO eLearning Training Schedule: 1. Live Opening Event (for All) - 22/01/25 2. Week 1: EU legal provisions - 27/01/25 - 31/01/25 3. Week 2: Licensing, Authorisation and Accreditation System - 03/02/25 – 07/02/25 4. Week 3: Quality Management System – overview - 10/02/25 – 14/02/25 5. Week 4: Quality Management System – good practices - 17/02/25 – 21/02/25 6. Week 5: Quality Risk Assessment - 24/02/25 – 28/02/25 7. Week 6: BTC Preparation Process Authorisation - 03/03/25 – 07/03/25 8. Week 7: SoHO Vigilance and Biovigilance - 10/03/25 – 14/03/25 9. Week 8: Serious Adverse Outcomes/Rapid Alerts and Harmonizing data collection - 17/03/25 – 21/03/25 10. Week 9: Stock and critical supplies, Import/export, Single coding - 24/03/25 – 28/03/25 11. Week 10: Inspection practice, inspection report and post inspection Activities - 31/03/25 – 04/04/25 12. Week 11: Risk for inspectorate - 07/04/25 – 11/04/25 13. Live Closing Event (for All) - 30/04/25 Please note that the registration process for this training will be managed directly by the SIGHTSoHO team. Stay tuned for further updates, and we look forward to receiving your applications soon. Best regards, 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 SIGHTSoHO HADEA/2022/OP/0018 ONLINE TRAINING INFORMATION SHEET - ROUND 2 - Context SIGHTSoHO (strengthening overSIGHT through training and networking on Substances of Human Origin) Service will provide blended training activities (eLearning and Face-to-Face) addressed to European inspectors, assessors and vigilance officers in the field of blood and blood components, tissues and cells (BTC), MAR and organs. In particular, SIGHTSoHO will significantly contribute to further encourage and promote: - the “formal” recognition of the commonalities among BTC oversight processes and the adoption of a common approach for the evaluation and inspection of SoHO; - the harmonisation and standardisation of some key minimum competencies/knowledge of SoHO inspectors, assessors and vigilance officers; - the strengthening of the existing network to foster trust between EU inspectorates and competent authorities (CA) to allow mutual recognition of certifications and authorisations of BTC establishments. Round 2 online training will be opened to all EU CAs working in the SoHO fields. The CAs are kindly invited to circulate this initiative among their local/regional/national networks. Online training objectives eLearning training aims to enabling participants: - to perform oversight activities with a common methodology at both national and European level (e.g., joint inspections, inter-Member State audits); - to keep up-to-date and/or receive training to undertake their duties also according to the new EU regulation on SoHO; - to enhance their technical and organisational skills by familiarising with the best practices in the field and to provide harmonised approach in the accreditation/designation/authorisation/ licensing processes; - to become proficient in surveillance and reporting procedures relating to serious adverse reactions/events; - to be part of a network of trained CA staff as well as European professionals community. Participants’ selection criteria and approach a. Be nominated or formally recognised as qualified inspectors/assessors/vigilance officers for one or more than one of the specific fields of blood, T&C, MAR and organs (in this latter case, only for the modules dedicated to Vigilance) by their CAs; b. Knowledge of EU BTC relevant legislation; c. Good command of the English language; d. Applicants who did not join Round 1 training; e. Round 1 priority list applicants will be preferred; f. >1 year experience; g. Priority to those applicants who showed interest in joining all the modules; h. for each Country, a proper both SoHO and professional activity coverage (inspector, vigilance officer and assessor); i. «first come, first served» principle. SIGHTSoHO HADEA/2022/OP/0018 Application procedure Application procedure to join Round 2 eLearning weekly modules is now open. Please, fill in the dedicated form at the following link https://forms.office.com/e/hWZGTXzPAe within December 20th, 2024 (23:59 CET). IMPORTANT: In order to finalise your application, please bear in mind that you are required to provide a formal commitment to attend the training modules for which you have expressed interest. The note will have to be signed also by the Competent Authority or your direct responsible person in order to allow your participation without restrictions. Once the application is submitted, please send the Note of Commitment to [email protected] If you do not share the Note of Commitment within one week from the submission of the application, your place will be reallocated to another applicant. In addition, please, take into consideration that if you are accepted and, once the eLearning training starts, you do not attend, you will be promptly contacted by SIGHTSoHO staff. If no answer is received, the DG SANTE team will inform your CA. SIGHTSoHO Platform The web platform SIGHTSoHO foresees sections dedicated to each weekly training module and it includes: a repository of the most relevant reference documents; pre-recorded presentations, links to join the synchronous live appointments, self-assessment and evaluation tests, as well as forum and interactive tools through which participants can liaise with tutors, post questions, share information and experience of mutual interest. The overall online training will offer effective and dynamic instructional methods such as practicing breakout rooms, combining collaboration activities with simulation, case studies, problem solving and group exercises always supported and facilitate by tutors. In order to become familiar with the eLearning platform, enrolled participants will receive credentials to access the IT tool where, once logged in, they can find Video Tutorials. The overall structure and contents of the eLearning training will be the same as the one of SIGHTSoHO Round 1 online training. Nevertheless, given the recent adoption of the new European regulation on SoHO, during Wednesday and Friday live appointments, specific insights relating to the topic of the weekly online module will be shared. SIGHTSoHO HADEA/2022/OP/0018 Modules and overall calendar Live Opening Event ONLINE TRAINING WEEK 1 22/01/25 The online training course will be delivered EU Legal Provisions weekly starting from January 27th 2025 to 27/01/25 - 31/01/25 April 11th 2025, as described in the figure. WEEK 2 Licensing, The 11 weekly modules will be preceded by Authorisation and a Live Opening event on January 22nd, 2025 Accreditation System and followed by a Live Closing event that will 03/02/25 – 07/02/25 be held on April 30th, 2025. WEEK 3 Quality Management Weekly training benefits from the use of System – Overview both synchronous (two live appointments 10/02/25 – 14/02/25 WEEK 4 each week) and asynchronous activities. A Quality Management detailed time schedule and training System - Good programme, including methodology and Practices activities, will be made available at WEEK 5 17/02/25 – 21/02/25 www.sightsoho.eu. Quality Risk Assessment (including tools) RESIDENTIAL COURSE 24/02/25 – 28/02/25 The online training will be followed by a WEEK 6 residential course, which consists of 3 face- BTC Preparation Process Authorisation to-face workshops of 3 days each in Rome: 03/03/25 – 07/03/25 − Inspection practice May 7 – 8 - 9, 2025 WEEK 7 SoHO Vigilance and − Vigilance June 11- 12- 13, 2025 Biovigilance − Preparation process authorisation July 10/03/25 – 14/03/25 2 – 3 - 4, 2025 WEEK 8 Serious Adverse Outcomes/Rapid Alerts SAVE THE DATE ON YOUR CALENDAR! and Harmonizing Data Collection 17/03/25 – 21/03/25 WEEK 9 Stock and Critical Supplies, Import/Export, Single Coding 24/03/25 – 28/03/25 WEEK 10 Inspection Practice, Inspection Report and Post Inspection Activities 31/03/25 – 04/04/25 WEEK 11 Risk for Inspectorate 07/04/25 – 11/04/25 Live Closing Event 30/04/25 This document was produced under the EU4Health Programme under a service contract with the European Health and Digital Executive Agency (HaDEA) acting under the mandate from the European Commission. The information and views set out in this document are those of the author(s) and do not necessarily reflect the official opinion of the Commission/Executive Agency. The Commission/Executive Agency do not guarantee the accuracy of the data included in this document. Neither the Commission/Executive Agency nor any person acting on the Commission’s/Executive Agency’s behalf may be held responsible for the use which may be made of the information contained therein. Note of Commitment Round 2 SIGHTSoHO eLearning training I , the undersigned _______________ ___ confirm my interest to attend the SIGHTSoHO Round 2 eLearning training organised within the SIGH T SoHO European Service (H a DEA/2022/OP/0018) . In particular, a s per the submitted application form, I commit myself to join the following weekly training modules: ☐ 1. EU legal provisions 27/ 01 /2 5 - 31 / 01 /2 5 ☐ 2. Licensing, Authorisation and Accreditation System 0 3 / 02 /2 5 – 07/ 02 /2 5 ☐ 3. Quality Management System – overview 1 0 / 02 /2 5 – 1 4 / 02 /2 5 ☐ 4. Quality Management System – good practices 1 7 / 0 2/2 5 – 2 1 / 0 2/2 5 ☐ 5. Quality Risk Assessment 24 /0 2 /2 5 – 28 /0 2 /2 5 ☐ 6. BTC Preparation Process Authorisation 03 /0 3 /2 5 – 07 /0 3 /2 5 ☐ 7. SoHO Vigilance and Biovigilance 10 /0 3 /2 5 – 14 /0 3 /2 5 ☐ 8. Serious Adverse Outcomes/Rapid Alerts and Harmonizing data collection 17 /0 3 /2 5 – 21 /0 3 /2 5 ☐ 9. Stock and critical supplies, Import/export, Single coding 24 /0 3 /24 – 28 /0 3 /2 5 ☐ 10. Inspection practice, inspection report and post inspection Activities 31 /0 3 / 25 – 04 /0 4 /2 5 ☐ 11. Risk for inspectorate 0 7 /0 4 /2 5 – 11 /0 4 /2 5 I hereby inform that my participation has been authorised by the Competent Authority / Direct Responsible I will be representing. Date __/__/___ Name and Last Name ______________________________ 212725 240030 40000 0 Applicant Signature Date __/__/___ Name and Last Name ______________________________ 226695 421640 40000 0 Competent Authority / Direct Responsible Signature SIGHTSoHO HADEA/2022/OP/0018 Note of Commitment Round 2 SIGHTSoHO eLearning training I, the undersigned __________________ confirm my interest to attend the SIGHTSoHO Round 2 eLearning training organised within the SIGHTSoHO European Service (HaDEA/2022/OP/0018). In particular, as per the submitted application form, I commit myself to join the following weekly training modules: ☐ 1. EU legal provisions 27/01/25 - 31/01/25 ☐ 2. Licensing, Authorisation and Accreditation System 03/02/25 – 07/02/25 ☐ 3. Quality Management System – overview 10/02/25 – 14/02/25 ☐ 4. Quality Management System – good practices 17/02/25 – 21/02/25 ☐ 5. Quality Risk Assessment 24/02/25 – 28/02/25 ☐ 6. BTC Preparation Process Authorisation 03/03/25 – 07/03/25 ☐ 7. SoHO Vigilance and Biovigilance 10/03/25 – 14/03/25 ☐ 8. Serious Adverse Outcomes/Rapid Alerts and Harmonizing 17/03/25 – 21/03/25 data collection ☐ 9. Stock and critical supplies, Import/export, Single coding 24/03/24 – 28/03/25 ☐ 10. Inspection practice, inspection report and post inspection 31/03/25 – 04/04/25 Activities ☐ 11. Risk for inspectorate 07/04/25 – 11/04/25 I hereby inform that my participation has been authorised by the Competent Authority / Direct Responsible I will be representing. Date Name and Last Name Applicant Signature __/__/___ ______________________________ Date Name and Last Name Competent Authority / Direct Responsible __/__/___ ______________________________ Signature This document was produced under the EU4Health Programme under a service contract with the European Health and Digital Executive Agency (HaDEA) acting under the mandate from the European Commission. The information and views set out in this document are those of the author(s) and do not necessarily reflect the official opinion of the Commission/Executive Agency. The Commission/Executive Agency do not guarantee the accuracy of the data included in this document. Neither the Commission/Executive Agency nor any person acting on the Commission’s/Executive Agency’s behalf may be held responsible for the use which may be made of the information contained therein.