GCP Regulatory and Advancements in Clinical Research Workshop

28 - 30 January 2020 | Frankfurt, Germany

COURSE OVERVIEW

Develop your understanding of the Good Clinical Practice framework that is the foundation for all clinical trials. The workshop will provide you with a detailed understanding of how GCP came to be instrumental in our clinical trials research industry. We will look at the history of GCP and the lessons learned. Sessions will cover various GxPs, US requirements, a new EU regulation (Clinical Trial Regulation 536 / 2014) and look at the impact of how the addendum to ICH-GCP has impacted Sponsors and Investigators. There will be discussion on practical applications of GCP, in line with preparation for the new regulations.This workshop will then focus on Advancement in Clinical Research, as a follow on from updates to GCP. The advancements covered will be topics within the Risk Based Approach, adaptations to clinical trial technology and how research site teams must develop their communication skills in line with this technology. There will also be a recap of common Regulatory Inspection _ndings, along with discussions on prevention in line with industry standard Quality Management Systems and CAPA management.

COURSE OBJECTIVES
  • Understand how Good Clinical Practice was developed and why
  • Outline the purpose of the relevant US Regulations, EU Directives, ICH-GCP (R2) addendum and Regulation 536/2014
  • Recognise and apply risk based approach in clinical research
  • Demonstrate an understanding of how to apply GCP to your individual role
  • Learn how to avoid common Inspection findings
  • Discuss speci_c ways to ensure patient safety and data integrity
WHO SHOULD ATTEND

Delegates should have a good understanding of ICH-GCP with clinical research experience within a sponsor, contrac research organisation, and investigational clinical research site or similar from Pharmaceuticals, Healthcare, CROs and Hospital industry:

Relevant departments may include but are not limited to:
  • Clinical Operations
  • Project Managers
  • Line Managers
  • Senior Clinical Researchers who have management capability
  • Clinical Research Site Managers
KEY BENEFITS
  • An opportunity for delegates to take their current understanding of GCP and apply it to advancements such as the risk based arena and oversight.
  • The program will act as a refresher session for advanced clinical researchers as it would cover updates such as ICH-GCP (R2) and the Clinical Trial Regulation 536/2014.
  • There will be opportunities for networking with like minded individuals and a chance to learn novel aspects of clinical research management from each other.
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