Senior Technical Specialist
- What has been the impact of EU MDR on combination products?
- Developing an effective regulatory strategy to navigate the complexities
- Availability of guidance documents for additional support
11:25 AM PANEL DISCUSSION: Navigating the Complex Regulatory Landscape from Both Drug and Device Approaches
- Understanding how combination products are defined and classified globally: EU, US and Asia
- Making sense of the regulatory contradictions and focusing on the specific requirements within the EU?
- Gaining a deeper understanding of the roles of Competent Authorities and Notified Bodies
- Post Brexit impacts on drug device combination product regulations
8:30 AM Workshop A: Navigating the Complex Regulatory Landscape to Ensure Compliance and Approval of Combination Products
The regulatory landscape within the EU has remained complex, confusing and inconsistent. It is continuing to evolve which adds to the challenge, but without ensuring compliance you are unable to launch a combination product.
This workshop will focus on the different regulations that apply to combination products and specific guidelines that will help ensure you remain compliant.
Attend this workshop to:
•Gain knowledge on the different regulations that apply currently to different combination products: Similarities and differences in drug and device regulations
•Learn how to develop and consolidate the standards into one streamlined process to meet the requirements throughout the lifecycle of the combination product
•Minimise and manage risks associated with regulatory challenges and identify key success factors
•Reduce the time spent on approvals and likelihood of agency push back
•Discuss how human factor considerations are assessed and controlled in the drug/device user interface