Spring Intro 2023

16/02/2023

What is an acceptable benefit-ratio?

• Non-serious condition • Existing drugs have major benefits and low risks • A new drug will also need major benefits and low risks

• Serious condition • Many existing drugs have

marginal benefits and high risks • Modest benefits and considerable

risks might still represent an acceptable benefit-risk ratio

The Organisation for Professionals in Regulatory Affairs

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Clinical development process

Elements of a CDP

Sequential “phased” process…

• Target product profile (TPP) or target SmPC (tSmPC) • Outline of each proposed study • Timelines, milestones and costs

…following a detailed clinical development plan (CDP)

• “Go” and “no go” criteria • Assessment of risks and alternative options

Regulatory professional’s role is to link medical and scientific aspects with regulatory needs

Therapeutic exploratory

Therapeutic confirmatory

Ph I

Ph IIa

Ph IIb

Ph III

Ph IIIb/IV

PMS

The Organisation for Professionals in Regulatory Affairs

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