GESTO platform: Publication of results of observational studies with medicinal products for human use After approval of the RD 957/2020 which regulates observational studies with medicinal products for human use it is mandatory the publication of results of…
NEW DATA PROTECTION CODE OF CONDUCT BY EUCROF Procedure and technical measures in order to comply with General Data Protection Regulation 2016/679 are being more and more standardized through codes of conduct in several fields. Until now, there…
FINAL APPROVAL EU PORTAL AND DATABASE BY EMA’s MANAGEMENT BOARD Great news upcoming! Yesterday, EMA’s Management Board confirmed that the clinical trial EU Portal and Database, is now fully functional and on track to go live by 31…
CLINICAL TRIALS REGULATION (EU) 536/2014 IMPLEMENTATION TRAINING Last month, The European Commission, Clinical Trials Facilitation and Coordination Group and European Medicines Agency (EC-DG SANTE/HMA-CTFG/EMA) imparted a joint training on the Clinical Trials Regulation (EU) 536/2014. The implementation to…
New regulation for observational studies with medicines for human use in Spain Last week, the Royal Decree 957/2020 which regulates the observational studies with medicines for human use was published in the BOE. This regulation will come into…
EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information…
Call for all sponsors to publish clinical trial results in EU database The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of…
BIOETHICS IN CLINICAL TRIALS The participation of a human being in a clinical trial generates a potential situation of vulnerability in which his/her rights must keep clearly protected. It is necessary that any medical investigation, which involves the…
Comunicación de Reacciones Adversas a Medicamentos a eudravigilance. Desde el pasado día 22 de noviembre de 2017 está disponible la nueva versión de EudraVigilance y comenzó un nuevo flujo de envío de sospechas de reacciones adversas a medicamentos…
La protección de datos – Nueva regulación adaptada a la era digital El Reglamento General de Protección de Datos (RGPD), que regula el tratamiento que realizan las personas, empresas u organizaciones de los datos personales relacionados con personas…
