Joint DIA/EFGCP Pharmacovigilance Audit and Inspection Workshop on

Opportunities for Patient Safety

1 October 2010, De Vere Venues Canary Wharf, London, United Kingdom

Organised by DIA in partnership with EFGCP

Pharmacovigilance inspections have been routinely performed since 2003 and resulted in increasing Marketing Authorisation olders (MAH’s) internal quality management activities. Given the changes in legislation and industry as well as the EU enlargement the vast experience in PV audits and inspections has demonstrated a steep learning curve by responsible agencies and MAH’s. Therefore, DIA and EFGCP have arranged a workshop in collaboration with the EMA and national authorities with the following objectives: • To provide a neutral platform for regulators and industry to jointly review experience from pharmacovigilance audits and inspections across national boundaries • To increase the common understanding of the role of pharmacovigilance inspections and improve future collaboration The one day workshop will be divided into one plenary session in the morning and parallel group break-out sessions in the afternoon. Each break-out session will be led by two facilitators (one agency and one industry representative), one of them acting as rapporteur. During a second plenary session in the afternoon each rapporteur will present the findings to the entire audience before closure of the workshop. Registrants will have the opportunity to sign up for one of the topics in the afternoon and also to submit a question for the panel discussion on ‘How to overcome inconsistencies of PV audit and inspection findings’.