CLINICAL TRIALS REGULATION (EU) 536/2014 IMPLEMENTATION TRAINING

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 a European level implies a Harmonization of the submission of a clinical trial from all Member States…

Acknowledgment for APICES collaboration in BIBABRAX Study published in Cancer Chemotherapy and Pharmacology

Acknowledgment for APICES collaboration in BIBABRAX Study published in Cancer Chemotherapy and Pharmacology Once again, we are privileged to share the acknowledgment that APICES has received in the recent publication titled “Phase II clinical trial of nab‑paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: the BIBABRAX study”  published…

New regulation for observational studies with medicines for human use in Spain

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 force on January 2, 2021 aims to simplify the procedures regulated by the Order SAS/3470/2009 taking into…

Acknowledgment for APICES collaboration in a study published in Blood Cells, Molecules, and Diseases.

Acknowledgment for APICES collaboration in a study published in Blood Cells, Molecules, and Diseases. This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A decade of changes in management of immune thrombocytopenia, with special focus on elderly patients” published in Blood Cells, Molecules, and Diseases in which…

Acknowledgment for APICES collaboration in DUTRENEO study presented as ORAL PRESENTATION at ASCO 2020 Annual Meeting.

Acknowledgment for APICES collaboration in DUTRENEO study presented as ORAL PRESENTATION at ASCO 2020 Annual Meeting. We want to share the acknowledgment that APICES has received in a recent ORAL PRESENTATION at the ASCO 2020 Annual Meeting by Dr. Enrique Grande. APICES has participated in medical writing monitoring, project management, safety, data management and statistics of the DUTRENEO study. This…

Acknowledgment for APICES collaboration in STREAM study published in Clinical and Translational Oncology.

Acknowledgment for APICES collaboration in STREAM study published in Clinical and Translational Oncology. This month, we want to share the acknowledgment that APICES has received in a recent publication in Clinical and Translational Oncology in which APICES has collaborated in several tasks of the project. This means to all APICES team an extra motivation in…

Raising pharmacovigilance awareness in the #MedSafetyWeek

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 across the globe simultaneously share campaign materials on their social media channels, with the hashtag #MedSafetyWeek. The…

Acknowledgment for APICES collaboration in a clinical trial published in Scientific Reports.

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 tasks of the project. This means to all APICES team an extra motivation in order to give…

VIII AECIC SUMMIT: EU 536/2014 CLINICAL TRIAL REGULATION

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 changes in daily processes in order to enhance working results and follow the evolution of clinical research.…