GCP for Experts

Hosted at: The Institute of Clinical Research Training Suite

Starts On: July 13, 2022

Finishes: July 13, 2022

10

CPD Points

The Course

This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP. It also explores the impact of EU data protection laws on clinical research and summarises other current issues that affect clinical trials.

Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook.

Learning Objectives

• Outline recent major developments in Good Clinical Practice

• Discuss the purpose and impact of EU regulations on the conduct of clinical research

•Outline the proposed Clinical Trial Regulation

• Summarise other current issues that affect clinical trials

e.g. risk based monitoring

Course Outline

• The need for ethics & regulation

• Roles & responsibilities in Clinical research

• EU Clinical Trials directive

• EudraCT database

• UK legislation

• The EU Regulation proposals

• Clinical trials authorisations

• Voluntary harmonisation procedure

• Substantial amendments

• IMPs & NIMPs

• HMA Strategies

• Informed consent

• GMP Annex 13

• Pharmacovigilance reporting

• Advanced therapy regulations

• Inspections

• Declaration of Helsinki 2008

• Risk based Monitoring

Course Documentation

To apply for this course, prices are dependent on your membership status:
Acceptance by WorldPay ensures that your place is booked and guaranteed
To pay by invoice please contact ICR on 01628 501700

Guest		ICR Member		ICR Member (Academic)
Debit card	Credit card	Debit card	Credit card	Debit card	Credit card
£550.00	£550.00