This interactive session is an opportunity for participants to share and compare cross-industry experience with the first marketing authorization submissions made public under EMA Policy 0070, and to learn best practices for working with the Agency.
Learning Objectives
Identify challenges with the implementation of EMA Policy 0070; Describe how to avoid common mistakes and missteps that could lead to invalidation of the draft or final document redaction package; Discuss best practices for responding to and gaining agreement with the Agency's redaction conclusions for the anonymization report and justification tables.
