In order to commercialize a health care product in the USA, the US FDA would need to approve it. But what is the standard process and how early would a company need to be involved and maybe even get advice? Additionally, the core question remains how could US FDA requirements be aligned with potential payer needs - are there any relationships?The #marketaccess veterans Dr. Stefan Walzer and Dr. Jamie Cross are discussing the principles as well as some very specific details. ✏️ Take the chance to stay connected and subscribe with your favorite podcast platform: <a href="https://lnkd.in/dyTZ3yQb" rel="noopener noreferrer" target="_blank">https://lnkd.in/dyTZ3yQb</a>MAP is the first and only bi-weekly <a href="https://www.linkedin.com/feed/hashtag/?keywords=marketaccess&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7075030139486527488" rel="noopener noreferrer" target="_blank">#marketaccess</a>podcast provided by MArS. For more information about <a href="https://www.linkedin.com/company/mars-market-access-&-pricing-strategy-ug-h-b-/" rel="noopener noreferrer" target="_blank">MArS Market Access & Pricing Strategy GmbH</a> visit: <a href="https://lnkd.in/db8aQWf" rel="noopener noreferrer" target="_blank">https://lnkd.in/db8aQWf</a> #podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations#pricing #drugs #medtech #usa #fda

In order to commercialize a health care product in the USA, the US FDA would need to approve it. But what is the standard process and how early would a company need to be involved and maybe even get advice? Additionally, the core question remains how could US FDA requirements be aligned with potential payer needs - are there any relationships? The #marketaccess veterans Dr. Stefan Walzer and Dr. Jamie Cross are discussing the principles as well as some very specific details. ✏️ Take the chance to stay connected and subscribe with your favorite podcast platform: https://lnkd.in/dyTZ3yQb MAP is the first and only bi-weekly #marketaccesspodcast provided by MArS. For more information about MArS Market Access & Pricing Strategy GmbH visit: https://lnkd.in/db8aQWf #podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations #pricing #drugs #medtech #usa #fda

In order to commercialize a health care product in the USA, the US FDA would need to approve it. But what is the standard process and how early would a company need to be involved and maybe even get advice? Additionally, the core question remains how could US FDA requirements be aligned with potential payer needs - are there any relationships?The #marketaccess veterans Dr. Stefan Walzer and Dr. Jamie&nbsp;Cross are discussing the principles as well&nbsp;as some very specific details.&nbsp;✏️ Take the chance to stay connected and subscribe with your favorite podcast platform:&nbsp;<a href="https://lnkd.in/dyTZ3yQb" rel="noopener noreferrer">https://lnkd.in/dyTZ3yQb</a>MAP is the first and only bi-weekly&nbsp;<a href="https://www.linkedin.com/feed/hashtag/?keywords=marketaccess&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7075030139486527488" rel="noopener noreferrer">#marketaccess</a>podcast provided by MArS. For more information about&nbsp;<a href="https://www.linkedin.com/company/mars-market-access-&amp;-pricing-strategy-ug-h-b-/" rel="noopener noreferrer">MArS Market Access &amp; Pricing Strategy GmbH</a>&nbsp;visit:&nbsp;<a href="https://lnkd.in/db8aQWf" rel="noopener noreferrer">https://lnkd.in/db8aQWf</a> #podcasthost #podcastshow #podcastepisode #marketaccess #marketaccesspodcast #reimbursement #pricingstrategy #negotiations#pricing #drugs #medtech #usa #fda

How do I get approved by the US FDA, Dr. Jamie Cross?

Market Access (or alternatively reimbursement) in health care is THE key competence in order to be commercially successful with a new drug, medical device or digital health application. However, given the fact that market access is a complex field involving various disciplines and is an ever-changing field, it is difficult to be up to speed with the different evolvements across the world.
 
MAP is THE bi-weekly Market Access Podcast provided by MArS Market Access & Pricing Strategy, which is your health care consultancy in the German-speaking markets and allows you to keep up to date with market access , reimbursement and pricing issues in the D-A-CH countries and around the world. With MAP you will get a summary of core market access systems and processes as well as latest changes in regulations including statements and opinions of core decision makers and stakeholders from various countries.
 
The CEO and founder of MArS is also the driver behind MAP: Dr. Stefan Walzer works in the field of payer strategy, pricing, health economics and reimbursement since 2004 and is the founder and CEO of MArS Market Access & Pricing Strategy GmbH based in Germany. MArS makes it as easy as possible for you to get your Pharmaceutical, MedTech or digital health product to the market and of course get the price it deserves.
Stefan previously worked as a payer consultant for various global pharmaceutical and medical device / diagnostic companies, successfully launching their products across the world. He was the Global Payer Strategy Leader for various products and compounds at F. Hoffmann – La Roche AG, where he successfully developed early payer strategies as well as launching and maintaining the reimbursement process for top brands and early compounds. Stefan is capable in translating the clinical and economic evidence into successful reimbursement submissions and pricing negotiations especially in Austria, Germany and Switzerland. Additionally he teaches market access, pricing and negotiations at the State University of Baden-Wuerttemberg and the University of Applied Sciences Weingarten-Ravensburg (both Germany).
Besides other roles and responsibilities. Stefan was the head of the committee “Inpatient care” of the German Health Economic Association (DGGÖ). Furthermore he is also a member of the Austrian Health Economic Association (ATHEA) and the Swiss Health Economic Association (SGGÖ). Additionally, he is a member of the Access Advisory Committee of the Global Pneumonia Prevention Coalition.
Stefan received a Master of Science in Economics from the University of Tuebingen (Germany), a PhD in Health Economics from the University of Zurich (Switzerland) and a post-graduate diploma in Clinical Trials from the London School of Hygiene and Tropical Medicine (UK). He is co-author of more than 40 peer-reviewed scientific articles and more than 300 scientific abstracts.

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Market Access (or alternatively reimbursement) in health care is THE key competence in order to be commercially successful with a new drug, medical device or digital health application. However, given the fact that market access is a complex field involving various disciplines and is an ever-changing field, it is difficult to be up to speed with the different evolvements across the world. MAP is THE bi-weekly Market Access Podcast provided by MArS Market Access & Pricing Strategy, which is your health care consultancy in the German-speaking markets and allows you to keep up to date with market access , reimbursement and pricing issues in the D-A-CH countries and around the world. With MAP you will get a summary of core market access systems and processes as well as latest changes in regulations including statements and opinions of core decision makers and stakeholders from various countries. The CEO and founder of MArS is also the driver behind MAP: Dr. Stefan Walzer works in the field of payer strategy, pricing, health economics and reimbursement since 2004 and is the founder and CEO of MArS Market Access & Pricing Strategy GmbH based in Germany. MArS makes it as easy as possible for you to get your Pharmaceutical, MedTech or digital health product to the market and of course get the price it deserves. Stefan previously worked as a payer consultant for various global pharmaceutical and medical device / diagnostic companies, successfully launching their products across the world. He was the Global Payer Strategy Leader for various products and compounds at F. Hoffmann – La Roche AG, where he successfully developed early payer strategies as well as launching and maintaining the reimbursement process for top brands and early compounds. Stefan is capable in translating the clinical and economic evidence into successful reimbursement submissions and pricing negotiations especially in Austria, Germany and Switzerland. Additionally he teaches market access, pricing and negotiations at the State University of Baden-Wuerttemberg and the University of Applied Sciences Weingarten-Ravensburg (both Germany). Besides other roles and responsibilities. Stefan was the head of the committee “Inpatient care” of the German Health Economic Association (DGGÖ). Furthermore he is also a member of the Austrian Health Economic Association (ATHEA) and the Swiss Health Economic Association (SGGÖ). Additionally, he is a member of the Access Advisory Committee of the Global Pneumonia Prevention Coalition. Stefan received a Master of Science in Economics from the University of Tuebingen (Germany), a PhD in Health Economics from the University of Zurich (Switzerland) and a post-graduate diploma in Clinical Trials from the London School of Hygiene and Tropical Medicine (UK). He is co-author of more than 40 peer-reviewed scientific articles and more than 300 scientific abstracts.

Market Access (or alternatively reimbursement) in health care is THE key competence in order to be commercially successful with a new drug, medical device or digital health application. However, given the fact that market access is a complex field involving various disciplines and is an ever-changing field, it is difficult to be up to speed with the different evolvements across the world.
 
MAP is THE bi-weekly Market Access Podcast provided by MArS Market Access &amp; Pricing Strategy, which is your health care consultancy in the German-speaking markets and allows you to keep up to date with market access , reimbursement and pricing issues in the D-A-CH countries and around the world. With MAP you will get a summary of core market access systems and processes as well as latest changes in regulations including statements and opinions of core decision makers and stakeholders from various countries.
 
The CEO and founder of MArS is also the driver behind MAP: Dr. Stefan Walzer works in the field of payer strategy, pricing, health economics and reimbursement since 2004 and is the founder and CEO of MArS Market Access &amp; Pricing Strategy GmbH based in Germany. MArS makes it as easy as possible for you to get your Pharmaceutical, MedTech or digital health product to the market and of course get the price it deserves.
Stefan previously worked as a payer consultant for various global pharmaceutical and medical device / diagnostic companies, successfully launching their products across the world. He was the Global Payer Strategy Leader for various products and compounds at F. Hoffmann – La Roche AG, where he successfully developed early payer strategies as well as launching and maintaining the reimbursement process for top brands and early compounds. Stefan is capable in translating the clinical and economic evidence into successful reimbursement submissions and pricing negotiations especially in Austria, Germany and Switzerland. Additionally he teaches market access, pricing and negotiations at the State University of Baden-Wuerttemberg and the University of Applied Sciences Weingarten-Ravensburg (both Germany).
Besides other roles and responsibilities. Stefan was the head of the committee “Inpatient care” of the German Health Economic Association (DGGÖ). Furthermore he is also a member of the Austrian Health Economic Association (ATHEA) and the Swiss Health Economic Association (SGGÖ). Additionally, he is a member of the Access Advisory Committee of the Global Pneumonia Prevention Coalition.
Stefan received a Master of Science in Economics from the University of Tuebingen (Germany), a PhD in Health Economics from the University of Zurich (Switzerland) and a post-graduate diploma in Clinical Trials from the London School of Hygiene and Tropical Medicine (UK). He is co-author of more than 40 peer-reviewed scientific articles and more than 300 scientific abstracts.

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How do I get approved by the US FDA, Dr. Jamie Cross?

How do I get approved by the US FDA, Dr. Jamie Cross?

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