New EU Clinical Trial – Regulation EU No 536/2014 2017-07-06T13:49:03+00:00
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New EU Clinical Trial Regulation 536/2014

This course can be tailored to your specific requirements.

DELIVERY FORMAT : These 90 minute live, instructor-led, webinars, enable participants to interact and ask questions. Contact us for details of our public webinars or to discuss a more detailed course specifically tailored to the needs of your organization.

Who is this course for?

This course is suitable for anyone who is involved in conducting clinical trials in Europe.  It will help you to gain an understanding of the regulation and prepare yourself and your organization.

Course Content

  • The single approval portal
  • Content of applications
  • Update on clinical trial transparency
  • Subject protection and informed consent
  • Progress reporting
  • Safety reporting
  • Reporting of serious breaches and urgent safety measures
  • Archiving of essential documents

Course Objectives

By the end of the course the participants will be able to:

  • Summarise the purpose of the new EU Clinical Trial Regulation
  • Compare the features of the new regulation with current EU directives
  • Discuss the impact of regulations on the conduct of clinical drug research in the EU
  • Analyse the potential impact of the new regulation on your organisation/job role

Webinar Course Support & Study Material

  • Each delegate will be provided with an electronic course workbook to support the webinar
  • IAOCR will provide three months free post-course support to all attendees

Learning Credits / Contact Hours / Continuing Education Points

People attending the webinar will receive 1 CPD/CME/CEP/CPE / contact hour.

The half day face-to-face program is equivalent to 5 CPD / CME / CEP / CPE / contact hours.

Corporate Roll-Out

We are experienced at providing large scale solutions, including “train the trainer” programs. Please contact us to discuss your requirements and how we can work in partnership with you.

Pedagogics

The training has been written by experts in clinical research training and education. The course caters for a range of learning styles and participants will be encouraged to interact with each other, contribute to group discussions and share their experiences.

Need Further Help?

We are able to provide a wide range of supporting clinical research and organizational development consultancy services.  Contact us to discuss to discuss your needs.

Contact us to see how we can help