062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer

062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer

I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy. Stefan discusses: Discounts, Rebates, and how Co-Payment is different in Europe How data is presented to payers in Europe and European Reimbursement Germany/AMNOG Process Negotiation Dr. Stefan Walzer is a healthcare economist, podcaster, and CEO of MArS Market Access & Pricing Strategy GmbH based in Germany. He previously worked as a payer consultant for various global pharmaceutical and medical device / diagnostic companies, successfully launching their products across the world. Dr. Walzer was also the Global Payer Strategy Leader for various products and compounds of 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. Dr. Walzer is experienced in the development of early payer strategies and the related evidence generation. Furthermore he is also capable in translating the clinical and economic evidence into successful reimbursement submissions and pricing negotiations especially in Austria, Germany and Switzerland. Additionally he also teaches at the Master course of Consumer Health Care at the Charité in Berlin (Germany) and is a tutor in market access and health technology assessment at the State University of Baden-Wuerttemberg (Germany). From 2018-2019 Dr. Walzer was the head of the committee “Inpatient care” of the German Health Economic Association (DGGÖ). Furthermore he is a leading member of the Special Interest group for Medicial Nutritions at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Dr. Walzer is also a member of the Austrian Health Economic Association (ATHEA) and the newly founded Swiss Health Economic Association. Additionally, he is also a member of the Access Advisory Committee of the Global Pneumonia Prevention Coalition. Dr. Walzer 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 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 100 scientific abstracts. Furthermore Dr. Walzer is the Editor in Chief of the German Journal of ClinicoEconomics (www.germanjournal-clinicoeconomics.de) and the lead author of the book chapter “Vergütungshöhe und Preissetzung” [Reimbursement value and pricing] in Business Planning in Health Care (http://www.springer.com/de/book/9783658081850). MAP Podcast: Link MAP Youtube Channel: Link

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240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances a...

3 Kesä 11min

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.The core question behind ICH Q12 is simple: once a ...

27 Touko 10min

239 - ICH Q11 in 6 Minutes

239 - ICH Q11 in 6 Minutes

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.He places Q11 in context with...

20 Touko 6min

238 - 6 Audit Strategies Every Auditor Should Know

238 - 6 Audit Strategies Every Auditor Should Know

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn this episode,...

13 Touko 10min

237 - ICH Q10: The Pharmaceutical Quality System

237 - ICH Q10: The Pharmaceutical Quality System

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style...

6 Touko 8min

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how i...

29 Huhti 12min

235 - ICH Q8: How Pharmaceutical Development Actually Works

235 - ICH Q8: How Pharmaceutical Development Actually Works

This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice.ICH Q8 defines...

22 Huhti 10min

234 - ICH Q7: The GMP Framework for API Manufacturing

234 - ICH Q7: The GMP Framework for API Manufacturing

In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read ...

15 Huhti 13min

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