What are drivers for a positive approval by Health Canada, Fraidianie Sévignè?

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Regulatory processes might vary across the world, EMA and FDA are mostly known, but what are drivers by Health Canada? What to consider when expanding e.g. from the US into Canada with a medical device? Are there differences between US FDA and Canadian decisions for drugs? And if so, why? The reimbursement veteran Dr. Stefan Walzer and the regulatory expert for Canada, Fraidianie Sévignè, discuss and recommend steps to consider for medical device and pharmaceutical companies.


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