Joint DIA/EFGCP Pharmacovigilance Audit and Inspection - Opportunities for Patient Safety

Date(s) And Time(s):
Oct 1 2010 7:00AM - Oct 1 2010 5:00PM

De Vere Venues
Canary Wharf
No. 1 Westferry Circus
E14 4HA
United Kingdom

Interest Area(s):
Clinical Research, Regulatory Affairs, Clinical Safety/Pharmacovigilance, Quality Assurance/Quality Control


Key Topics
Audit and inspection findings related to:
• Management of individual case safety reports such as assessment of case validity, lack of efficacy, information derived from the Internet
• Record retention and storage, paper versus electronic records
• Pharmacovigilance quality system, structure, documentation, Detailed Description of Pharmacovigilance Systems (DDPS) updates, role of European Qualified
Person for Pharmacovigilance (QPPV)
• Reporting of inspection findings, assessment against internal/external references, interpretation of regulatory requirements, consistency across inspections,
options for dialogue and escalation

Other aspects:
• Targeted versus routine inspections
• Feedback from assessments relevant to pharmacovigilance quality system
• Affiliates inspections in the EU and rest of the world
• Inspections of licensing partner, distributors and vendors
• Best practices on how to prepare, conduct, report a pharmacovigilance inspection – mutual experience and recommendations
• Role of performance metrics in pharmacovigilance quality systems

Target Audience:
Who Will Attend
Professionals from regulatory agencies, industry, non-profit organisations involved in clinical research, drug safety monitoring and related quality management

Event Code:

Contact Information:
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52