Device – Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process
Our 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 an 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.
Who should attend?
- Professionals working in Regulatory Affairs, Research and Development
- Medical device and pharmaceutical workers
- Project managers and any staff involved in the product to market process
- Differentiate between a medical device and medicinal product in terms of classification
- Introduce and 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 documentation that requires submission
- Evaluate changes made after a product goes through the CE marking process
- Increase your speed to market
- Decrease your risk of liability
- Manage your risks better
- Provide better assurance to stakeholders
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