FDA GFI, M10 Bioanalytical Method Validation and Study Sample Analysis, 11/22 Beatrice Burtsov2022-11-16T10:19:27+00:00November 16th, 2022|
EMA Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources, DRAFT, 09/22 Beatrice Burtsov2023-06-09T07:22:46+00:00November 16th, 2022|
FDA GFI, Drug and Biologiacal Products that Contain Nanomaterial, 04/22 Beatrice Burtsov2022-11-09T10:28:26+00:00November 9th, 2022|
FDA GFI, Charging for Investigational Drugs Under an IND Q&A, DRAFT, 08/22 Beatrice Burtsov2022-11-09T10:22:07+00:00November 9th, 2022|
EU Clinical Trials Regulation EU 536/2014, Questions & Answers, Version 6.2, 09/22 Beatrice Burtsov2023-06-09T07:21:35+00:00October 5th, 2022|
EMA Guideline on responsibilities of sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with GCP and GMP Beatrice Burtsov2022-10-05T11:26:37+00:00October 4th, 2022|