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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MAP is the first and only bi-weekly market access podcast provided by MArS. For more information about MArS Market Access and Pricing Strategy, visit: marketaccess-pricingstrategy.de
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In Europe, there are at least as many reimbursement assessment processes in place as European countries. Some of these are transparent and clearly defined like the German AMNOG process, others are even more complex and sometimes even unclear, dependent also on the product of interest. Anyhow, the European Commission has already decided that a European joint assessment will come into place in 2025 starting with oncology and ATMP products. Anyhow, currently timelines and national processes to implement the outcomes of the European evaluation are still unclear and to be defined. Dr. Stefan Walzer and Dr. Elvira Mueller discuss the current status as well as issues and potential solutions for the new upcoming reimbursement start in Europe.
Take the chance to stay connected and subscribe with your favorite podcasting platform or directly listen on our website: https://lnkd.in/dZtyKw8B
MAP is the first and only bi-weekly market access podcast provided by MArS. For more information about MArS Market Access and Pricing Strategy visit: marketaccess-pricingstrategy.de
#podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations #pricing #germany #Europe #JointHTA
It seems to be a given, that prices in the US are higher than in the rest of the world. But what might happen, if the US refuses to pay these higher amounts anymore? There are already changes either approved or heavily discussed like the pricing inflation act, the cap on out-of-pocket cost and the opportunity for Medicare negotiating prices starting in 2026. If the global price system changes, it will become even more important to get the price right from the beginning.
Those and other questions are discussed by the market access and pricing experts Dr. Stefan Walzer, Dr. Renato Dellamano and Dr. Jack Mycka.
Take the chance to stay connected and subscribe with your favorite podcasting platform or directly listen on our website: https://lnkd.in/dZtyKw8B
MAP is the first and only bi-weekly market access podcast provided by MArS. For more information about MArS Market Access and Pricing Strategy visit: marketaccess-pricingstrategy.de
#podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations #pricing #germany #US #Europe