The science comprising scientific knowledge from a range of disciplines, including basic and applied medicinal sciences and social sciences, that develop policy measures to guarantee the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the life cycle of a medicine, aiming to ensure the safety and well-being of the populations.
Published in Chapter:
Clinical Research and Regulatory Affairs: Skills and Tools in Pharmacy Education
Maria Teresa Herdeiro (iBiMED, Medical Sciences Department, University of Aveiro, Portugal), Nélia Gouveia (NOVA Medical School, Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Portugal), and Fátima Roque (Health Sciences School, Polytechnic Institute of Guarda, Portugal)
Copyright: © 2021
|Pages: 25
DOI: 10.4018/978-1-7998-4486-0.ch008
Abstract
Clinical research is a large umbrella, and it mainly includes the implementation of clinical studies/trials. This field is crucial to assess the value of new developments in healthcare, be it new therapeutic interventions, medical devices, or systems of care. In order to protect human rights, the implementation of clinical trials is complex and extremely costly. In this context, medicines and medical devices are strongly regulated products before and after the market authorization. So during their training, pharmacists must develop skills in the area of regulatory affairs, design and methodology of clinical trials, and other clinical studies, as well as in the management of clinical projects to be prepared for the challenges of the clinical research and market access processes. With that purpose, knowledge and skills for clinical research should be developed in association with regulatory affairs.