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Benefit-risk management

We continually assess the balance between benefit and risk throughout a product’s lifecycle – from early development, during clinical trials, and once the product is on the market.

We evaluate and document all available safety information to build a detailed benefit-risk profile of each product. This is used to develop a Benefit-Risk Management Plan, which identifies ways to improve a product’s benefits and minimise any risks. Plans are reviewed and updated regularly during clinical development and for a period after a product is approved for marketing.

Any changes to the benefit-risk profile of a product are communicated to regulators, see Collecting and reporting safety data.