CRED Managing Variations Effectively

Objectives: • Procedures:

» Type IA : immediate notification and “annual reporting” » Type IB/II Grouping: Art 7.2 and Annex III » Worksharing: Art 20 and Annex III - purely National WS » CMDh - arbitration

• MHRA Experiences: • Type IA: scientific validation, common deficiencies • Type IB/II: grouping quiz - Quality and Clinical variations • Worksharing • Strategy for classification Type IA, IB or II • Risk-based approach • Batch Specific Variations (BSV) • Summary: some hints & tips

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