Post-approval life cycle change management is one of pharmaceutical operations’ most consequential yet most neglected disciplines.
As change volumes soar and experienced teams thin out, Megha Sinha of Kamet Consulting Group illustrates why systematic action is imperative now.
Every product in a marketed pharmaceutical portfolio exists in a state of continuous post-approval change.
Corporate structures alter, manufacturing sites move, suppliers change and formulations evolve, necessitating a range of regulatory updates and changes to product labelling internationally.
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