Module 12 Presentations

Life Cycle Management example

Current view 0002 Current view 0000 0001 Current view 0002

Sequence 0001

Sequence 0002

Sequence 0000

Doc A 1 Doc A 1

Doc A 1

Doc A

NEW

REPLACE

Doc B Doc B Doc E Doc E Doc B

Doc B

Doc E

NEW

NEW

Doc C

Doc C

Doc C

NEW

DELETE

Doc D 1 1 Doc D

Doc D

Doc D 1

NEW

REPLACE

Doc E+E1 Doc E Doc E+E1

Doc E

NEW

Doc E1

APPEND

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SUBMITTED APPROVED

SUBMITTED APPROVED

The Organisationfor Professionals in Regulatory Affairs

Slide 60 New Pharmacovigilance legislation