The Combination Products Forum is dedicated to regulations governing the development of combination products.
Topics
- Improving your medical device and pharma team collaboration
- Multi-functional stakeholders are bought in to the lifecycle
- CGMPs
- Policy developments from pre-market through post-market, including on pathway availability, bridging and human factors
- Notified body interpretations of Article 117 and expectations for manufacturers
- Post-market safety reporting
- The differing submission requirements for combination products in emerging markets such as China, Malaysia and South Korea
- How to interpret risk management requirements
Who should Attend
Senior attendees with responsibilities in:
- Regulatory Affairs
- Combination Products
- Product Development
- Quality Compliance and Assurance
- Device Development
- Human Factors
- Packaging
- Product Usability Engineers
- Regulatory Affairs
- Combination Products
- Product Development
- Quality Compliance and Assurance
- Device Development
- Human Factors
- Packaging
- Product Usability Engineers
