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Work programme 2017

WC500221614

Risk Mitigating actions

Risk Mitigating actions and controls for inspectors (ongoing activity) • EMA-FDA GCP initiative in the area of GCP inspections (ongoing) • Request for certain information to applicants through the Q&A of inspections included in the pre-submission guideline • Inspection validation of the MAA • Reduction of duplication of inspections with consequent resource saving leading to wider range of sites being inspected at global level In progress: • Informal network of GCP inspectors to enable capacity-building For GLP In place: • The OECD programme • Validation process of MAAs feeds into the decision on inspections (site selection) • Request for certain information to applicants through the Q&A of inspections included in the pre-submission guideline • Promoting the verification of the GLP status of sites at the time of the Clinical trial application rather than MAA. Pharmacovigilance Lack of additional postmarketing authorisation data on human medicines to proactively identify, qualify and quantify risks Inability of the Agency to effectively conduct veterinary pharmacovigilance if suitable IT system is not developed to replace EVVET2 For PhV In place: • The ICH programme • Inspection programmes • PhV inspectors working group • Implementation of new legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) • Planned international cooperation • International cooperation through training activities • Cooperation between EMA and Member States on inspections in 3 rd countries In progress: • Informal network of PhV inspectors to enable capacity-building In place: • Launch of post-authorisation studies using ENCePP network • Independence, transparency and methodological standards of ENCePP studies ensured • Implementation of pharmacovigilance legislation (PASS and PAES) • 'Best evidence' procedure to support PRAC discussions In progress: • Longitudinal patient record databases used for EMA studies (in-house and commissioned studies) • Registries initiative • Real-world evidence monitoring In place: • Maintain expertise and knowledge in house to ensure EVVet 2 can continue to operate until a replacement system is developed Planned: • Replace existing technology for EVVet 2 with more modern technology as a first step to a complete revision/replacement of the system Work programme 2017 EMA/583016/2016 Page 112/123

Table 2 – Support activities Risk Mitigating actions and controls Data management – data protection and security Accidental leak of confidential information to external parties by internal employees, interims, trainees or contractors with access to EMA information systems Intentional leak of confidential information to external parties by internal employees, interims, trainees or contractors with access to EMA information systems Sensitive and/or confidential data intentionally accessed or removed from EMA premises by external suppliers Financial, legal and reputational damages for the Agency in case of data-protection failure Data management – data quality Data required for scientific and In place: • IT security policies and strategy implemented and continuously reviewed • Security officer and dedicated information security service • IT tools including adequate security measures to protect confidential data • IT security measures to manage access to data • Declaration of confidentiality and conflicts of interests for staff and for IT contractors • Annual checks to validate the control of access to database by users • Security tools against data leak (EudraLink to secure package, End point security) • USB restriction on laptops Planned: • Security road map project In place: • Policy and procedures in place • Data-access management • Datacentre access limited to relevant resource • Access control lists to restrict contractors' data access; checklist to manage contractors' access to IT systems • Data-encryption tools to allow data transfer between parties outside the EMA network • USB restriction on laptops Planned: • Data logs activated on all systems (where possible) and red flags set up and actively monitored • Proactive markings on sensitive documents • Each new system account given appropriate level of access and necessary access restrictions applied • Access rights reviewed on regular basis to ensure permissions are appropriate In place: • Security awareness training • Code of conduct • CCTV • Access control • Printing control • Confidential waste stored in locked confidential bins Planned: • Guidance on 'clear desk policy' In place: • Identification of systems to be notified and regular management review • Data protection Regulation (EC) 45/2001 • Data protection implementing rules • Data Protection function within the Agency • Appointment of data protection officer (DPO) • Notification procedures from data controllers to DPO • Notification procedures from DPO to EDPS • Register of data processing in place • Training programme for existing members of staff and new comers • Data protection microsite on intranet • Regular bi-lateral meetings scheduled between Executive director and DPO In place: Work programme 2017 EMA/583016/2016 Page 113/123

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