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Track 9: Regulatory

DIA 2017: Driving Insights to Action

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, EMA, PMDA, MHRA, BfArM, and ICMRA authorities, and other regulatory experts will provide global updates, insights, and discussion on current issues, opportunities, and challenges through interactive forums. Themes include, Global Regulatory Changes and Impact on Global Development Strategies, Global Harmonization/Convergence and Impact on Drug Development, Advances and Innovations to Improve the Practice of Regulatory Affairs, and Regulatory Hot Topics.

Sessions in Regulatory

Sunday, June 23 | Short Courses

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Monday, June 24

Tuesday, June 25

Wednesday, June 26

Thursday, June 27

View one of our video interviews from DIA 2018 with Demetra Macheras, Director, Regulatory Affairs, Abbvie, Inc., as she explains the regulatory challenges in the development and lifecycle management of drug-device combination products.

Who is This Track Designed For?

Professionals involved in: Regulatory affairs and strategy, regulatory operations, regulatory information management, regulatory agencies, government affairs, legal affairs and compliance, policy and intelligence, clinical research and operations, PV, HTA, project management, and service providers developing tools and resources for use by sponsors and CROs.

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