Drug delivery technologies are becoming increasingly complex and integrated, combining various advanced technologies with the intent to deliver the drug with the right dose, at the right time and right location, in the right way.
The goal of this webinar is to look at this drug-device co-development journey from 5 key aspects: Regulatory & Quality Assurance, Time & Costs, Legal/Contracts, Global Development, and Knowledge & Resources. We utilize a drug/device case study to illustrate the importance of co-development and communication between device and pharma industry. We also compare and contrast the current US and EU combination product regulatory pathways and provide considerations for strategy and good practices for drug/device combination products.
Key topics include:
- Comparing and contrasting the differences between device and drug regulation to bridge gaps in understanding and develop integrated combination product strategies.
- Integrating Regulatory & Quality Assurance, Time & Costs, Legal/Contracts, Global Development, and Knowledge & Resources into an overall product development strategy and assessing their impacts on FDA and EU Medical Device Regulation.
- As the new MDR coming into force soon and FDA guidance evolves, anticipate it whenever possible during the co-development journey.
We were pleased to receive so many questions during our webinar. We have compiled a Q&A summary for you to use as a quick reference guide. Webinar Q&As