Spring Intro 2023

Jenny Lamport

Directive 2001/83/EC Article 12.1 as amended  ‘The necessary technical or professional qualifications which shall be set out in a brief curriculum vitae’  Article 2: of original Directive 2001/83: ● ‘The analyst’ ● ‘The pharmacologist or the specialist with similar experimental competence’ ● ‘The clinician’ Who is an expert?

The Organisation for Professionals in Regulatory Affairs

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CTD format – Module 2

Summaries

– 2.1 Table of contents – 2.2 Introduction – 2.3 Quality overall summary – 2.4 Nonclinical overview – 2.5 Clinical overview – 2.6 Nonclinical summary ) – 2.7 Clinical summary )

written and tabulated

The Organisation for Professionals in Regulatory Affairs

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