10 OCTOBER 2019: “The production of the drug for experimental use”

Posted by admin
On 5 August 2019
0 Comments

Regulation: the EudraLex vol. 4 GMP - Annex 13 reference legislation Activities related to the preparation of the IMP, description of the process: The incoming material; Primary packaging: production of capsules, inflation, blistering; Secondary packaging: MLAF and labelling[...]

25 June 2019: BASIC PHARMACOVIGILANCE

Posted by admin
On 23 April 2019
0 Comments

Basic Pharmacovigilance in Clinical Trials: common evaluation tools, the responsibility of the promoter An interactive seminar during which participants will be able to have a regulatory update on current pharmacovigilance obligations in the field of clinical research and an interaction with specialized professionals in the sector, belonging both to the hospital and to the corporate world, with the aim to verify the common tools available to correctly evaluate the PV activities necessary to conduct a clinical trial[...]