10637 Professional Development courses delivered On Demand

Name: Social Work Training at QLS Level 5
Price: 100 GBP
Availability: InStock

CT03: ICH Good Clinical Practice

By Zenosis

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

Delivered Online On Demand3 hours

£149

CT01: How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive

By Zenosis

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.

CT01: How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive

Delivered Online On Demand3 hours

£149

CT10: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

By Zenosis

An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.

CT10: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

Delivered Online On Demand3 hours

£149

PV03: Drug Safety and Pharmacovigilance

By Zenosis

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.