25 мар. 2015 г. Legal requirements of the EU portal and EU database ... The functional specifications have to address the following systems requirements:.
22 июн. 2012 г. ... database (or other systems to collate adverse reaction ... should ensure that the tasks are subject to a quality system compliant with the legal ...
18 нояб. 2021 г. Audits of the pharmacovigilance system should ensure that it complies with the legal requirements the human ... systems or regulatory databases ...
28 мар. 2017 г. The legal requirement for marketing authorisation holders to maintain and make available upon request a pharmacovigilance system master file ( ...
“A core requirement of the Internet Numbers Registry System is to maintain a registry of conditions and legal requirements of the RIPE Database. The ...
“A core requirement of the Internet Numbers Registry System is to maintain a registry of allocations legal requirements of the. RIPE Database. The requirement ...
15 дек. 2022 г. • Point 8 covers the functional specification derived from the legal requirements for the EUDAMED Information system. The functional ...
9 мар. 2023 г. system or database(s). In case of manual ... intended use is covered by local legal requirements and the in-house rules of the institution.
Disposal methods must meet the requirements stated in PPP (Policies Practices and Procedures). Section 1.9.11. h. Information received from a CLETS terminal
LEGAL DATABASE SYSTEM TO SUPPORT THE EASE OF DOING BUSINESS. By: Tyas Dian official Rules of Procedure of the. European Council; how the European. Council ...
28 mar. 2017 PSMF section on computerised systems and databases . ... The legal requirement for marketing authorisation holders to maintain and make ...
25 mar. 2015 Draft prepared with the clinical trials information system expert ... Legal requirements of the EU portal and EU database .
22 jun. 2012 The legal requirement for quality systems was introduced by ... and to databases to authorised personnel respecting the medical and ...
Ideally the legal entities obtaining EU funds would be linked to BRIS in their presentation on the reporting system's website
20 dic. 2021 on draft regulatory technical standards under Article 9a (1) and (3) of. Regulation (EU) No 1093/2010 setting up an AML/CFT central database ...
18 nov. 2021 complying with the legal requirements for pharmacovigilance tasks and responsibilities. The pharmacovigilance system of the marketing ...
systems. P1 explain the principles of database systems. M1 explain the legal requirements for a database system. 2 Be able to create non-.
Summary of legal requirements applying to EHRs The move towards centralised databases of electronic health records marks a fundamental shift in the.
10 jun. 2021 Legal and regulatory background . ... Training requirements for computerised systems . ... Database decommissioning .
Many regulatory compliance requirements focus on privileged insiders as well with special database system beyond his/her level of authorization.