Module 1 2021

28/06/2021

Why seek advice

Clinical program/Protocol assistance • Efficacy and Safety data package • Scope and definition of populations • Age, gender, ethnicity; pharmacogenomics • Dosage form, formulation • Labelling messages, esp. safety • For target territories • Use of key opinion leaders (KOLs) • Local medical practice • Relevant regional guidelines/medical practice • Comparators

The Organisation for Professionals in Regulatory Affairs

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In this presentation we will cover

• What advice do you need?

• Why seek advice?

• Advice in the regulatory strategy of SMEs

• When should you seek advice?

• Where should you seek advice?

• How seek advice?

• What to do with the advice?

The Organisation for Professionals in Regulatory Affairs

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