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GCP INSPECTIONS – INTERNATIONAL COLLABORATION AND HARMONISATION EFFORTS

Track:
Globalisation/Inspections

Day & Time:
March 26, 4:00PM - 5:30PM (Central European Standard Time)

Session Number:
1004

Room Number:
Room LM

Type:
Session

Title:
GCP INSPECTIONS – INTERNATIONAL COLLABORATION AND HARMONISATION EFFORTS

Chair(s):
Ana Rodriguez, PhD
Head of Clinical and Non-Clinical Compliance
European Medicines Agency, European Union, United Kingdom

Description:
Clinical trials increasingly occur on a global scale, with significant growth of activity in so-called emerging economies. This change in location of clinical development activities has numerous implications not only for the patients and health care providers but also for the sponsors of those trials and the regulatory agencies around the globe responsible for their supervision. There is growing concern both among regulators and in public debate about how well these trials are conducted from an ethical and scientific/organisational standpoint (including GCP compliance) and about the available framework for the supervision of these trials. Initiatives in reaching a common understanding and framework for ethical and scientific standards, achieving a strong regulatory and ethical framework in all countries where clinical trials are conducted, sharing of expertise and delivery capacity in these emerging economies, increasing the number of third country GCP inspections and the need to improve the international collaboration on GCP inspections will be reviewed during this session.

Presentation(s) & Speaker(s):
Regulator’s Experience of GCP Inspection Conducted Including in Emerging Markets
Gunnar Danielsson
Senior Regulatory Advisor
Pharma Consulting Group, Sweden

Industry Perspective/Experience on GCP Inspection
Kristel Van De Voorde
Director Quality and Regulatory Compliance-Europe
Bristol-Myers Squibb International Corp., Belgium

Current GCP Collaboration/Harmonisation Activities
Ernesto Vera
Head of Sector,Good Clinical Practice and PhV Inspection Area
Agency of Medicines and Medical Devices (AEMPS), Spain