Two Day Clinical Trial Regulatory Requirements Course (London, United Kingdom - January 25-26, 2018) - Research and Markets

DUBLIN--()--The "Clinical Trial Regulatory Requirements" conference has been added to Research and Markets' offering.

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered. Attending this course will help ensure you are familiar with the regulatory requirements for running clinical trials and with these recent developments. The course will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for pharmaceutical, biotechnology companies and study sites.

Key topics to be covered include:

  • The current requirements of the EU Clinical Trial Directive
  • The EU Clinical Trial Regulation (536/2014)
  • The impact of Brexit
  • Clinical trial authorisations
  • Complexities for running paediatric trials
  • Requirements for managing investigational medicinal products
  • Legal aspects of clinical trials
  • Requirements of pharmacovigilance
  • New ICH GCP R2 guideline requirements
  • Regulatory inspection
Why you should attend
  • Decipher the framework of clinical trial regulations and guidelines in Europe
  • Gain an update on the new EU Clinical Trial Regulation and the recently finalised ICH GCP R2 Guideline
  • Discuss the impact of Brexit
  • Understand clinical trial authorisations: regulatory and ethical approval n Realise the most important legal aspects of clinical trials
  • Ensure you comply with pharmacovigilance and adverse event reporting
  • Make certain you are prepared for regulatory inspections

For more information about this conference visit https://www.researchandmarkets.com/research/d284hv/clinical_trial

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Clinical Trials, Medical Law

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Clinical Trials, Medical Law