Raising pharmacovigilance awareness in the #MedSafetyWeek This week is the Annual Pharmacovigilance Week, organized by Uppsala Monitoring Center and led in Spain by Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). For one week in November, medicine regulators…
Acknowledgment for APICES collaboration in a clinical trial published in Scientific Reports. This month, we want to share the acknowledgment that APICES has received in a recent publication in Scientific Reports in which APICES has collaborated in several…
VIII AECIC SUMMIT: EU 536/2014 CLINICAL TRIAL REGULATION AECIC (Asociación Española de Compañías de Investigación Clínica/Spanish association of CROs) is aware of the continuous development and innovation in clinical research. Thus, it is necessary to include improvements and…
Acknowledgment for APICES collaboration in a clinical trial published in BMC Cancer. This month, we want to share the acknowledgment that APICES has received in a recent publication in BMC Cancer in which APICES has collaborated in several…
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…
ICH Releases Draft Revision of E8 Guideline, General Considerations for Clinical Trials Since the last update of ICH6 (R2) on 2017, ICH was working on a new release, a new revision of ICH E8 about General Considerations for…
Acknowledgment for APICES collaboration in a clinical trial published in The Oncologist. Many times the work of CROs is not totally acknowledged. But, fortunately, this is not always the case. This month, we want to share the acknowledgment…
AEMPS UPDATES GCP SECTION On April 24th 2019, AEMPS updated the contents of GCP section. Two points were updated: New version of serious protocol breaches notification form. Prohibition of FDA 1572 form in clinical trials carried out in…
NEW TREATMENT OPTION FOR PATIENTS WITH SPINAL CORD INJURY This month has been published a relevant article about a new therapeutic advance. A patient with spinal cord injury can walk again after being treated with NC1, a new…
