To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.
Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access
2 QLS Endorsed Course | CPD Certified | Free PDF + Hardcopy Certificates | 80 CPD Points | Lifetime Access