Description

Regulatory Courses

 

 You need a clear and hands-on understanding and be up-to-date of the most current national regulatory legislation for Clinical Trials with investigational medicinal products but also medical devices within one or multiple specific European Countries?

We cover the majority of countries and courses are developed in a consistent way, to offer a similar learning experience. Visit our catalogue regularly, as we are expanding it on a monthly basis.    

You can book this course only or book a bundle and pay less: the more Local Clinical Trial Legislation courses you take the less you pay per course !

  

This eLearning course will fulfil your expectations in a very practical way. It is an interactive approach to review and comprehend local regulations, and you can learn at your own pace.

It is designed and regularly updated by local subject matter experts to always reflect the latest status of local legislations, both for medicinal products and medical devices.

Interactive quizzes for self-assessment are included to provide a better understanding of the course. You will be able to test your comprehension with a final grading assessment.

All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.

Course time
At your own pace; the course wil remain available online for you for 3 months after you register for it.------------------------ Course Credits: 1,5 hours
Who should attend
  • Everyone involved in clinical research, including: Pharmaceutical companies, Contract Research Organisations (CROs), Investigators, Site Personnel.
  • People from clinical operations, regulatory affairs, quality assurance and pharmacovigilance departments involved in monitoring activities (on-site or medical monitoring) of investigational sites.
  • Everyone who wants to acquire knowledge of the Local Regulatory Requirements.
  • Everyone who needs to comply local regulatory training requirements prior to performing work locally.
Programme highlights
  • Legal Framework governing clinical trials with investigational medicinal products and medical devices
  • Process, timelines and fees for achieving clinical trial authorisation from the competent authorities (Ethics Committee and National Competent Authorities)
  • Amendments & End of Trial Notification
  • Safety Reporting

Click the link to open the Course Programme and get detailed information about the course structure and chapters duration

Learning Objectives
  • Get an overview of the local clinical trial legislation in, for both medicinal products and medical devices
  • Be able to identify and create legally required documents
  • Know the procedures to be compliant and reach successful clinical trials submissions.

Book a course

Date Lang Location
* Book now and learn at your own pace within the next 3 months
Book a bundle and pay less
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.
150,00 € excl. VAT (if applicable)

Testimonials

Antonina Nabokova
November 2016
Company
SynteractHCR

Ms. Nelle Stocquart executed the course in the excellent interactive manner, using the certain technical tools (like drawing) to keep the audience engaged and really participating in the session.
She perfectly followed the core idea of the program - to present the summary of all basic principles and last developments of Clinical trials Regulations in Russia.
Our team enjoyed the course and the opportunity to work with Ms. Nelle Stocquart.