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Boston Convention and Exhibition Center

2018 年 06 月 24 日 8:30 上午 - 2018 年 06 月 28 日 12:00 下午

415 Summer Street, , Boston, MA 02210 , USA

DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Avoiding Rejection on your "First Date" with EMA Policy 0070

Session Chair(s)

Jo Anne-Marie  Blyskal, MS

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.

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