Module 1 2021

25/06/2021

Pre-authorisation

Evaluation

Post-authorisation

Research and clinical development

Dossier review

Lifecycle Management

Procedural Advice

Submission package

Review and Outcome

Post-approva l

Clinical trials

•Acceptability of historical controls •Surrogate endpoints •Trial activity by disease type

•Precedent for deviating from scientific advice •Trends on application legal bases •Approved PIPs for disease type RI Sources • RI intel. Briefs • Guidance • Cortellis

•Dossier content for fixed dose combinations •Re-use of invented names •Market specific requirements for

•Review and approval outcomes and timelines •Advisory Committee outcomes •Divergent CHMP opinions RI Sources •Pharmapendium • EPARs

•Trends on PAMs •REMS and additional risk minimisation measures •Which markets require post- approval surveillance studies RI Sources • Regulator data • Vendor databases

international submissions

Examples

RI Sources • Internal database • EMA Q&As RI urces

RI Sources • Trialtrove • SBAs

The Organisation for Professionals in Regulatory Affairs

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RI input for regulatory strategy & product development

Regulatory intelligence can enable faster, more effective decision-making and reduce or eliminate compliance risk

Three case studies

Procedural – Orphan designation(s)

Clinical Trial Endpoints

Metrics data- PRIME

The Organisation for Professionals in Regulatory Affairs

12

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