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Abstract

This article is not meant to present solutions. Its goal is to encourage readers to contribute and submit their ideas to the Drug Information Journal (DIJ) on two main subjects in the regulatory galaxy: the challenges and opportunities of the proactive safety trend and the eSubmission initiatives. Proactive safety and eSubmissions are dramatically broadening the scope of regulatory affairs across all stages of the drugs' life cycles and portfolio. We also propose topics in the hope of stimulating authors to prepare submissions on these or related topics.

Keywords

Proactive safety eSubmission eCTD Regulatory affairs Life cycle management Standardization Risk management

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References

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Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions

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