CRED Managing Variations Effectively

Summary: some tips Take regard of your responsibilities Type IA

– Large number of possible changes  flexibility/responsibility – Ensure you satisfy the admin/conditions/documentation aspects – Reject rate is still too high (15%); avoid common deficiencies Grouping Type IB/II (+Type IAs) – Group where possible – must be sensible/meaningful – Refer to CMDh, MHRA other CA websites – for examples – Request prior approval only if necessary – complex/grey cases – Apply to RIS

What if you can’t group? …….

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