Module 1 2021

30/06/2021

Masterclass

Regulatory Strategy in Orphan Drug Development Keeping your stakeholders aligned

01 July 2021

Liesbeth Hof, Regulatory Affairs, ProPharma Group

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

• Rare conditions • Regulatory context • Defining an orphan condition • Significant benefit • Global environment • Stakeholders • Challenges and opportunities

The Organisation for Professionals in Regulatory Affairs

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