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Track 9: Regulatory

This track is composed of sessions addressing global laws, regulations, guidelines, and guidances that govern prescription biopharmaceutical and device product development, approval, and maintenance. Representatives from FDA, Health Canada. NMPA, PMDA, EMA, MHRA, European Health Authorities and ICMRA authorities, and other regulatory experts will provide global updates, insights, and discussion on current issues through interactive forums. Themes commonly revolve around Global Regulatory Changes and Impact on Global Development Strategies, Global Harmonization/Convergence and Impact on Drug Development and Advances and Innovations to Improve the Practice of Regulatory Affairs, and Regulatory Hot Topics are always prominently featured.

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