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International Guidelines on Prescribing Information

Pharma issued a global directive requiring harmonisation of Prescribing Information (PI) across all territories and to ensure compatibility with Core Prescribing Information (CPI). Selected to develop proposals to reduce number of CPI texts. Proposed new CPI format, reducing 4 texts to 1 CPI; consulted regulatory affairs experts; wrote new International Guideline on PI; ensured IG was clinically sound & obtained regulatory sign off; and issued IG. Succeeded in securing approval for new IG, improving PI quality & enabling resolution of regulatory issues.

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