Module 12 2019

Life Cycle Management example

Current view 0002 r t i 000 rr t i 1 Cu rent vie 02

Sequence 0001

Sequence 0002

Sequence 0000

Doc A 1 oc A 1 c

Doc A 1

Doc A

NEW

REPLACE

Doc B Doc B Doc E oc E oc B

Doc B

Doc E

NEW

NEW

Doc C

Doc C

Doc C

NEW

DELETE

Doc D 1 oc D 1 Doc D

Doc D

Doc D 1

NEW

REPLACE

Doc E+E1 Doc E oc E+E1

Doc E

NEW

Doc E1

APPEND

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SUBMITTED APPROVED

SUBMITTED APPROVED

The Organisation for Professionals in Regulatory Affairs

Slide 72 New Pharmacovigilance legislation