Drug Device and Combination Products 2016

Topics

• Regulatory and development strategies for device and drug led combination products
• Developments and progress on the revision to the Medical Device Directives
• New US FDA guidance, case study examples from Sanofi and clarification from UL
• Human Factors/usability testing, including:
• China, Japan, ASEAN and Latin America
• Gaining market approval in key emerging markets, including
• Unannounced manufacturer audits: what to expect, how to prepare and what they have seen in practice
• The implications of Competent Authority audits of Notified Bodies and the formation of Team NB
• How manufacturers are overcoming leachables assessment challenges and the latest best practice recommendations from PQRI

Who should Attend

Directors, Managers, Specialists and team members from Medical Device and Pharmaceutical manufacturers including:

• Quality assurance
• Regulatory affairs
• Technical
• Development
• R&D