Date: 10 April 2025
Time: 16:00h - 17:00h CET
Location: Virtual
Language: English
Introduction
leverage relevant data efficiently to ensure compliance and drive innovation. Yet, how to balance between gaining meaningful insights without losing your grasp on regulatory demands?
Join us in this webinar as industry experts Nienke Flipsen-Maassen (Qserve) and Maria Axetun (Viedoc) present best practices around structuring your data collection, avoiding pitfalls common in this area, and further optimizing for post-market surveillance, clinical evaluation, and regulatory submissions.
The webinar consists of a 45-minute presentation and a live Q&A. Questions for the Q&A session can be sent in through the registration form, by email at marketing@qservegroup.com or during the webinar.
Agenda
- Welcome & Introduction
- Navigating Regulatory Data Requirements: Writing an Effective Data Management Plan
- Technical Considerations: Choosing an EDC
- Ensuring Data Quality: Review, Validation, and Finalization
- Live Q&A
This webinar will be co-hosted by Viedoc.
Learning Objectives
- Understand the key regulatory expectations for data collection under MDR, IVDR, and other global frameworks.
- Learn practical strategies to efficiently collect, analyze, and utilize high-quality data to support compliance and business growth.
Who should attend the webinar?
This webinar is essential for professionals in the medical device and in-vitro diagnostic industry who are responsible for collecting, analyzing, and utilizing data to ensure regulatory compliance and business success. Key attendees include:
- Regulatory Affairs Specialists & Managers
- Clinical & Post-Market Surveillance Teams
- Quality Assurance & Compliance Officers
- Medical & Scientific Affairs Professionals
- R&D and Product Development Teams.
Qserve Speaker