Clinical trials in Corona (Covid-19) time. [Regulatives / Guidelines]

posted by wienui  – Germany, Oman, 2020-03-29 07:15 (488 d 14:58 ago) – Posting: # 21305
Views: 1,613

(edited by wienui on 2020-03-29 07:30)

Hello,

EMA released on Wednesday a new draft guideline for 4-week public consultation on points that clinical trial sponsors should consider on the implications of the coronavirus disease (Covid-19) on methodological aspects of ongoing trials.

https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en.pdf

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

Cheers,
Osama

Complete thread:

Activity
 Admin contact
21,594 posts in 4,515 threads, 1,532 registered users;
online 5 (1 registered, 4 guests [including 3 identified bots]).
Forum time: Friday 22:14 CEST (Europe/Vienna)

It is a capital mistake to theorise before one has data.    Arthur Conan Doyle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5