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Regulatory Requirements for Clinical Trials - Including an Update on the Proposed Changes to the Clinical Trial Directive Requirements

Management Forum

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Course Description

Benefits of Attending: Decipher the framework of clinical trial regulations and guidelines in Europe Discuss the Clinical Trial Directive process for overcoming the problems of the Directive (2011 consultation) Gain an Overview of the EU Clinical Trial Directive and GCP Directive and some of the key issues Understand Clinical Trials Authorisations: Regulatory Approval and Ethical Approval What are the Implications of Running clinical trials in Children: The Paediatric Plan and Ethical considerations Understand the Legal aspects of clinical trials Ensure you Comply with Pharmacovigilance & Adverse Event Reporting Discuss Clinical Trial Data Management including EDC and e-source Understand FDA requirements including recent developments. WHO SHOULD ATTEND The course is relevant for Clinical research professionals in pharmaceutical, biotechnology CRO and SMO companies, or study sites including investigator initiated studies. It will also be relevant to those departments who liaise / support clinical trial personnel (such as regulatory affairs, clinical trial supply, drug safety quality assurance, document management, legal, regulatory authorities, and all other professionals who want to know more about regulations and guidelines covering clinical trials.) With Dr Laura Brown Independent QA expert and Training Consultant in the Pharmaceutical Industry & Director of the MSc in Clinical Research, School of Pharmacy, University of Cardiff, UK

Benefits of Attending: Decipher the framework of clinical trial regulations and guidelines in Europe Discuss the Clinical Trial Directive process for overcoming the problems of the Directive (2011 consultation) Gain an Overview of the EU Clinical Trial Directive and GCP Directive and some of the key issues Understand Clinical Trials Authorisations: Regulatory Approval and Ethical Approval What...

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