2:15PM – 3:00PM
EU Perspective to Product Quality Complaints, Defect Reporting and Market Action
Noel Gaule, Head of Product Quality Surveillance, QP, SHIRE
- Explore postmarketing compliance activities such as complaints, recalls, BOH notifications, market holds, continuity of supply notifications, DHCP notifications, etc.
- Address strategies for voluntary recalls and when they are appropriate
- Focus on recall processes and when to determine a recall
- Review recalls, market withdrawals, and safety alerts, and understand the differences in these three elements