Advances in scientific knowledge and technology are driving growth and innovation for “combination products” - therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. This innovation continues to blur the historical lines separating traditional drugs, biologics, and medical devices. The regulatory landscape is dynamic and the development and marketing authorization pathways for combination products raise unique challenges when compared to drugs, devices, or biological products alone.  These differences impact many aspects of product life cycle management, including pre-clinical and clinical evaluation, regulatory approval processes, manufacturing and quality controls, post-market surveillance, adverse event reporting, promotion and advertising, and post-approval modifications.

This conference will provide practical approaches and up-to-date information for combination product development processes and regulatory requirements.  The two-day conference will include:

• Updates from FDA and other regulators
• Combination product cGMP requirements and practical approaches
• Current “hot” topics in marketing applications
• Collaboration with various partners in developing combination products
• Interactive case studies to enhance learning