This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers, which would like to enter such geographical market, on key elements to consider. In addition solutions to maximize the product development strategy are discussed, with the intention of bridging regulatory and market access gaps.
Daniel Muscionico, PharmD, MPH, MBA, Paloma Grasser, MTIM, BSc, Rosa Mouchotte, MSc, RAC and Anne Rambaud
April 2016 - Regulatory Affairs Professionals Society
Daniel Muscionico, Chief Operating Officer
Daniel has accumulated over 20 years of management experience, with Profit & Loss responsibility, in the life science industry, specializing in financial services, risk management and information security. He is also a senior lecturer in the fields of healthcare economics and public health at the Institute of Global Health, Geneva Faculty of Medicine, where he earned his Doctor of Pharmacy degree.
Paloma Grasser, Senior Analyst Market Access
Paloma is supporting the key analyses and strategy development for client engagements across global markets.She helps international clients understand the real world value of their products and how to demonstrate it to both regulators and payers.
Rosa Mouchotte,Director Drugs Biologics and ATmPs
Rosa leads projects involving the design and implementation of regulatory strategy for the development of medicinal products such as new chemical entities, biologicals as well as Advanced Therapy Medicinal Products (ATmPs). Her global expertise and understanding of CMC, nonclinical and clinical regulatory requirements allow her to understand and manage the challenges faced by drug developers, notably in the case of innovative products such as ATmPs