×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
Avoiding Rejection on your "First Date" with EMA Policy 0070
Session Chair(s)
Jo Anne-Marie Blyskal, MS
Head of Global Regulatory Medical Writing and Data Disclosure
Teva Pharmaceuticals, United States
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 Objective : 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.
Have an account?