Annual Conference

3 September 2024 – Novartis Campus Basel, Switzerland

Program Committee

Mike Wallenstein

Global Head RA Medical Devices, Combination Products & Precision Medicine

Novartis

Bio

Mike is Global Head RA Medical Devices, Combination Products & Precision Medicine at Novartis Pharma AG since August 2022. In this role, Mike oversees all regulatory activities related to Medical Devices & Combination Products and Precision Medicine at Novartis globally. Prior to this role Mike was managing the EU MDR implementation at Novartis. Mike joined Novartis in 2010 as Global Auditor in Group Compliance and Audit, and developed further into a role as Executive Director in QA, overseeing all compliance activities related to Medical Devices & Combination Products at Novartis. Before joining Novartis, he was Director Global Audit Systems at Gambro Renal Care (today Baxter), and European Head Quality Systems & Audits at 3M. Mike is a member of several US and EU Expert Committees and Interest Groups on Combination Products, and lecturer at the Universities in Baltimore (US) and Bern (CH) on Medical Devices & Combination Products. Mike studied Chemical Engineering and Plastic Technologies in Münster, Germany, and has over 25 years of experience in QA, R&D, and Manufacturing within the Medical Devices & Pharmaceutical Industry.

Fanny Barbotin

Regulatory Affairs Sr. Manager

BD

Bio

Nathalie Schober-Ladani

Senior Director Public Affairs and Regulatory Intelligence

SFL

Bio

Nathalie is a Member of the 2023 Medtech & Pharma Program Committee. In her role as Senior Director Public Affairs and Regulatory Intelligence at SFL Regulatory Affairs & Scientific Communication GmbH, she provides strategic policy and regulatory intelligence support to interdisciplinary projects for a wide range of products in the life sciences field such as in vitro diagnostics.

With her expertise in law and policy making processes in Switzerland and the European Union, she plays a crucial role in the engagement and organizational work of national and international associations. With a main interest in innovative product development and through regular interaction with stakeholders from academia, industry and patient groups, she has insights into different perspectives on current health policy topics including digital health. Nathalie holds an MD from the Medical University of Vienna, Austria, and a Master of Laws degree in Medical Law with emphasis on the legal framework for Advanced Therapy Medicinal Products.

Theresa Jeary

Global Head, Medicinal & Biologics Team

BSI

Bio

Jasmin Barman-Aksözen

 

University of Zurich

Bio

Jasmin Barman-Aksözen studied molecular biology and biochemistry at the University of Heidelberg and obtained her PhD and Venia Legendi from the University of Zurich. She is a patient with the ultra-rare inborn error of metabolism erythropoietic protoporphyria (EPP). Her research topics cover basic science and drug development in EPP and related diseases (the porphyrias), as well as aspects concerning the regulatory assessment and benefit evaluation of orphan drugs. During her PhD, she was involved in the development of the first drug for treating her own condition and later became a patient representative for the respective approval proceedings at the European Medicines Agency. To promote access to therapy for patients with EPP and other porphyrias, she co-founded the International Porphyria Patient Network, a group of dedicated patient advocates with a professional background in science, medicine, and other relevant expertise. She is working at the Institute for Laboratory Medicine at the Municipal Hospital Zurich, which is the Swiss Reference Center for the Porphyrias, and is currently studying health economics and methods of health technology assessment at the University of Applied Sciences in Winterthur. In addition, Jasmin is a steering committee member of ITINERARE, the university research priority programme on Innovative Therapies for Rare Diseases at the University of Zurich.

Marie-Claire Beurier

Regulatory Group Director

Roche

Bio

Marie-Claire Beurier is a Regulatory Group Director at F. Hoffmann-La Roche Ltd, Basel. She graduated as an engineer in analytical chemistry in France. In 1998, she started her professional career in analytical development in the veterinary industry in the Netherlands at Intervet (now MSD Animal Health). Then she moved to France and continued to develop in analytical and CMC activities as a technical regulatory lead. In 2002, she joined Roche Basel and worked in regulatory affairs as Country Manager for the Middle East. She further developed into a DRA manager role for mature products for several years , then as an EU partner in oncology drug development and for another 9 years as Global Regulatory Lead. Her areas of expertise are in oncology lung and tumor agnostic which are disease areas involved with many biomarkers and companion diagnostics. Particularly, Marie-Claire was the GRL for the new molecule entrectinib (trade name Rozlytrek) targeting NTRK and ROS biomarkers. For the last 2 years, Marie-Claire moved into line management of EU oncology program managers and is also involved with regulatory infrastructure activities. In this context, Marie-Claire has been heavily involved with the implementation of IVDR at Roche.

Mike Wallenstein

Global Head RA Medical Devices, Combination Products & Precision Medicine

Novartis

Marie-Claire Beurier

Regulatory Group Director

F. Hoffmann-La Roche

Fanny Barbotin

Regulatory Affairs Sr. Manager

BD

Nathalie Schober-Ladani

Senior Director Public Affairs and Regulatory Intelligence

SFL Regulatory Affairs & Scientific Communication GmbH

Jasmin Barman-Aksözen

 

University of Zurich

Theresa Jeary

Global Head, Medicinal & Biologics Team

BSI

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