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Special Episode with EUCOPE-Part 2 with Alexander Natz

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In this episode Chloe & Alexander will be starting the discussion with an overview of EU HTA regulation, looking at the harmonization debate and how this came about. We then discuss JCA evaluation methodology (e.g. comparator selection, acceptability of clinical evidence), the potential new role of individual country agencies and how the joint HTA process will link to national processes. EUnetHTA21 and how the methodology is evolving with G-BA & IQWIG increasingly involved, will this be a major influence in the development of final methodology? Finally, we look at how Pharma companies should be best preparing for the implementation of the regulation.

Host: Chloe Sheppard

Guest Speaker: Alexander Natz

Produced by: Operations team

Helpful links:

#EUHTAPriorities – EUCOPE’s Five Priorities for a Successful EU HTA Procedure

Sounds of Science Podcast – Episode 1: A Future-Proof HTA system in Europe?

https://partners4access.com/whitepapers/pan-european-joint-hta-what-does-the-future-hold-for-innovative-therapies/

About Alex:

Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he worked as a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Dr. Natz has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling

Email: natz@eucope.org

LinkedIn: https://www.linkedin.com/in/alexander-natz-63467433/

About EUCOPE:

For more than a decade, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has been the voice of small to mid-sized health technology companies in Europe. As a trade association, we advocate for sound public policy that supports innovation, while fostering a community built on a shared purpose: improving and saving the lives of European patients through innovative therapies and medical technology.

Website: https://www.eucope.org/

  continue reading

95 tập

Artwork
iconChia sẻ
 
Manage episode 333011473 series 2324999
Nội dung được cung cấp bởi Partners4Access. Tất cả nội dung podcast bao gồm các tập, đồ họa và mô tả podcast đều được Partners4Access hoặc đối tác nền tảng podcast của họ tải lên và cung cấp trực tiếp. Nếu bạn cho rằng ai đó đang sử dụng tác phẩm có bản quyền của bạn mà không có sự cho phép của bạn, bạn có thể làm theo quy trình được nêu ở đây https://vi.player.fm/legal.

In this episode Chloe & Alexander will be starting the discussion with an overview of EU HTA regulation, looking at the harmonization debate and how this came about. We then discuss JCA evaluation methodology (e.g. comparator selection, acceptability of clinical evidence), the potential new role of individual country agencies and how the joint HTA process will link to national processes. EUnetHTA21 and how the methodology is evolving with G-BA & IQWIG increasingly involved, will this be a major influence in the development of final methodology? Finally, we look at how Pharma companies should be best preparing for the implementation of the regulation.

Host: Chloe Sheppard

Guest Speaker: Alexander Natz

Produced by: Operations team

Helpful links:

#EUHTAPriorities – EUCOPE’s Five Priorities for a Successful EU HTA Procedure

Sounds of Science Podcast – Episode 1: A Future-Proof HTA system in Europe?

https://partners4access.com/whitepapers/pan-european-joint-hta-what-does-the-future-hold-for-innovative-therapies/

About Alex:

Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he worked as a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Dr. Natz has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling

Email: natz@eucope.org

LinkedIn: https://www.linkedin.com/in/alexander-natz-63467433/

About EUCOPE:

For more than a decade, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has been the voice of small to mid-sized health technology companies in Europe. As a trade association, we advocate for sound public policy that supports innovation, while fostering a community built on a shared purpose: improving and saving the lives of European patients through innovative therapies and medical technology.

Website: https://www.eucope.org/

  continue reading

95 tập

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