DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/vsl38q/drugdevice_and) has announced the addition of the "Drug/Device & Device/Drug Combinations in the EU and USA" conference to their offering.
The demarcation between medicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating a medicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals and medical devices. This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.
Benefits of Attending:
- Understand the European Regulatory Guidance
- Know what your Competent Authority expects
- Gain an insight into Notified Bodies considerations on drug/device products
- Learn how to define the approval route for your product
- Clarify the major differences in documentation and approval routes
- Consider quality systems requirements for combination products
- Discover FDAs Regulatory approach to combination products
- Hear how to deal with Human Tissue Engineered products
- Stay up-to-date on Post Market Surveillance for combinations products.
A Certificate of Attendance for Professional Development will be given to each participant who completes the course.
For more information visit http://www.researchandmarkets.com/research/vsl38q/drugdevice_and