The EU Clinical Trial Regulation Virtual Course

The EU Clinical Trial Regulation Virtual Course
Product Code: The EU Clinical Trial Regulation Virtual Course
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Price: £675.00

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The EU Clinical Trial Regulation.

Day 1 overviews the current status and summarizes the content of the CTR. Day 2 looks at the guidelines, related Regulations, CTIS, Q&A document and implementation considerations.

Contact us for additional dates

This virtual course consists of two 2-hour webinars.
It will be interactive and involve presentations, workbook tasks, discussion, poll questions and participants Q&A.

Part 1: “Overview and implementation of the CTR”

  •          Current EU legislation.
  •          The need for a Regulation.
  •          When the CTR can be implemented.
  •          Current situation and likely ‘go-live’ date.
  •          Structure of the CTR and supporting guidelines.
  •          Interventional, non-interventional and low interventional trials.
  •          Authorization of a clinical trial – a single application.
  •          Notifications required.
  •          The application flow chart and timescales.
  •          Substantial and non-substantial modifications.
  •          Conditions for conducting a clinical trial.
  •          Site suitability statement.
  •          Investigator’s Brochure updates.
  •          Additional informed consent requirements.
  •          Consent for vulnerable patients.
  •          Compensation.
  •          Withdrawal of consent.
  •          Safety reporting.
  •          Serious breach reporting.
  •          Urgent safety measures.
  •          Summary of trial results.
  •          Trial Master File and document retention.

Participants Q&A.

Participants will be asked to do some preparation for Part 2 based on a workbook to be provided.


Part 2: “CTR guidelines, harmonisation templates, Q&As and implementation considerations”

  •          The Clinical Trial Information System (CTIS) – what is it?
  •          Functionality of the CTIS.
  •          CTIS training and user requirements.
  •          Transparency and publicly accessible information.
  •          Sponsor workspace and applications.
  •          Harmonisation guidance and templates.
  • Compensation for trial participants template.
  • Investigator Curriculum Vitae template.
  • Declaration of interest template.
  • Site suitability form.
  • Informed consent and patient recruitment procedure template.
  •          GMP and Regulations of IMP and Auxiliary Medicinal Products.
  •          Summaries of Clinical Trial Results for Laypersons.
  •          Ethical considerations for clinical trials on medicinal products conducted with minors.

·         Questions and Answers Document - Regulation (EU) 536/2014 – your chance to decide on a course of action (workbook and discussion)

The interplay between the Clinical Trials Regulation and the General Data Protection Regulation (GDPR).

·         Other guidelines to note – brief mentions of the other guidelines that need to be considered.

  • Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - EMEA/CHMP/SWP/28367/07 Rev. 1 (July 2017).
  • Risk proportionate approaches in clinical trials (April 2017).
  • Detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
  • Recommendation on the content of the trial master file and archiving.

Key points for implementing the CTR - sponsors and investigators.

Participants Q&A.

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