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Computers, mobile devices, wearables and other biosensors are gathering and storing health-related data in such vast amounts, it's dizzying. Want to prepare your quality management system (QMS) to obtain real-world evidence (RWE) you can actually use? You can, with the help of this free webinar.
Webinar Takeaways:
- What the regulatory landscape looks like for RWE, particularly the FDA's Quality Framework to support a new drug or device regulatory filing
- What programmatic changes you must adopt to set up a RWE program
- The study feasibility process and its relationship to achieving "evidence quality", including examples of study feasibility parameters
- How to identify new RWE-related roles and responsibilities
- Best practices to help you implement quality assurance/quality control processes in RWE
- Key quality compliance program enhancements
Speaker:
Jan Pierre
Principal Consultant, IQVIA
