EMA Guideline on computerised systems and electronic data in clinical trials, DRAFT, 03/21 Anastasija Eschricht2023-03-21T12:33:43+00:00March 21st, 2023|
EMA Notice to sponsors on validation and qualification of computerised systems used in clinical trials, 04/20 Anastasija Eschricht2023-03-16T14:29:27+00:00March 16th, 2023|
FDA GFI, Content of Human Factors Information in Medical Device Marketing Submissions, DRAFT, 12/22 Anastasija Eschricht2023-02-24T09:18:26+00:00February 24th, 2023|
FDA GFI, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, 12/17 Anastasija Eschricht2023-02-24T09:13:59+00:00February 24th, 2023|
EMA Guidance, Recommendation paper on decentralised elements in clinical trials, 12/22 Anastasija Eschricht2023-02-24T09:09:11+00:00February 24th, 2023|
MDCG 2022 20 Substantial modification of performance study under Regulation (EU) 2017/746, 12/22 Anastasija Eschricht2023-02-24T08:57:56+00:00February 24th, 2023|