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Tuesday, June 26 • 2:15pm - 3:15pm
#269B: Avoiding Rejection on your "First Date" with EMA Policy 0070

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Component Type: Workshop
Level: Advanced

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.

Chair

Jo Anne-Marie Blyskal, MS


Speakers
avatar for Jo Anne-Marie Blyskal

Jo Anne-Marie Blyskal

Head of Global Regulatory Medical Writing and Data Disclosure, Teva Pharmaceuticals
Jo


Tuesday June 26, 2018 2:15pm - 3:15pm
E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA