The new draft guidance on CGMP requirements for combination products
Office of Combination Products Update
The combination product development process
Other recent and upcoming guidances and issues
Companion diagnostics regulations, guidances, and challenges
Clinical evidence development and coordination for combination products
Industry assessment of FDA review of combination products
FDA assessment of combination product submissions
Quality by Design vs. Design Control
Aligning pharmaceutical CGMP and device Quality System Regulations
Human factors and combination products – paradigm matching
Risk management and combination products
Combination product inspections
Reconciling drug and device postmarket requirements and processes
Combination products in a global marketplace
Who should Attend
Product stewards
Drug, device, diagnostics, and biologics regulatory, quality, and clinical professionals involved with combination product development and oversight
R&D and product testing professionals
Business development executives involved in combination product strategic partnerships
Combination product supply chain professionals
Past Events
Human Factors and Design Controls for Medical Devices and Combination Products 2015 - 30 Sep - 01 Oct, 2015, Boston, Massachusetts, United States (53572)
Important
Please, check "Human Factors and Design Controls for Medical Devices and Combination Products" official website for possible changes, before making any traveling arrangements
