This one day course has been designed to provide manufacturers with the knowledge and skills to interpret the requirements of the drug consultation process for devices containing ancillary medicinal substances.
Attendance on this course will provide guidance on how to reduce risks and uncertainty in the EU regulatory process. Participants will gain an appreciation of the realistic timescales involved for the consultation process and awareness of common mistakes to avoid, ensuring delays are minimized.
This course focuses on determination of the applicable European legislation for borderline products, and provides insight into further information and guidance related to the distinction between medical devices and medicinal products. This course also examines devices incorporating derivatives of human blood or plasma.
On completion of the training, participants be able to:
- Differentiate between a medical device and medicinal product in terms of classification
- Provide an overview of the GMP requirements for devices containing ancillary medicinal substances
- Explain the key stages involved in the consultation process
- Guide a product development team through the planning process identifying realistic timescales
- Explain the consultation documentation requirements
- Identify common pitfalls and potential competent authority questions in relation to the drug consultation
- Appreciate notified body expectations in relation to submission documentation
- Evaluate changes made post CE marking
Who Should Attend
Medical Device and Pharmaceutical:
- Professionals working in Regulatory Affairs, Research and Development
- Project managers and any staff involved in the product to market process
Participants should have experience and/or a basic knowledge of either pharmaceutical or medical device product development. Together with an awareness of the Medical Device Directive 93/42/EEC or pharmaceutical legislation Directive 2001/83/EC.
This course can be delivered as in-company training, customized for specific organizations and their circumstances.