Module 1 2021

28/06/2021

Why seek advice

Optimize drug development strategy • - When the drug is a new molecular entity • - When there is a novel indication • - When the drug is intended to treat a serious or life- threatening disease • - When there are no current guidance documents • - When there are pharmacologic or toxicologic signals of concern • When there are sponsors new to drug development • …..

The Organisation for Professionals in Regulatory Affairs

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Why seek advice?

Reduce time to market • Clearly define endpoints and goals of the development program • Target Product profile / Target claims/labelling • Identify and avoid unnecessary studies • Ensure that necessary studies are designed to provide useful information • Gain Agency support for a proposed strategy • Provide opportunity for creative exchange of ideas • Obtain regulatory insight • Minimize costs • Allow early interactions/negotiations with Agency • Maximise benefits of international development

The Organisation for Professionals in Regulatory Affairs

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