CRED Managing Variations Effectively

[1] Type IAs : Elena Razzano Experiences: overview

• most popular change codes • automatic validation / rejection • rejection rates • common deficiencies

[2] Type IB/II/IA Grouping

• acceptable/non-acceptable examples • impact on fees and strategy • MHRA processing of queries • Worksharing – model example [3] Deciding on Type IA, IB II (a judgement call) • Strategy for classification: risk based assessment • Batch Specific Variations (BSV)

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