Lessons Learned Implementing EMA Policy 70
The European Medicines Agency has recently published their guidelines for the requirements under Policy 70. Many companies that are covered by Policy 70 still have questions about how to implement the guidelines, such as:
- How to quantitatively measure the risk of re-identification?
- Which line listings are out of scope?
- What do actual Anonymization Reports look like?
- How do we deal with aggregate tables?
In this webinar we will discuss these issues, and many others, that have come up during the course of working with clients to implement Policy 70 and interactions with the EMA. This webinar will be of value to those companies making submission to the EMA and that need to prepare anonymized documents and reports.