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Swissôtel Le Plaza

Oct 24, 2019 9:00 AM - Oct 25, 2019 5:30 PM

Messeplatz 25, 4005 Basel, Switzerland

Value, Access & Regulatory Evidence Workshop

Acknowledging the different perspectives and finding the pragmatic way forward


Lucia  D'Apote, DrSc, RAC

Lucia D'Apote, DrSc, RAC

Executive Director Global Regulatory and R&D Policy (ELMAC and JAPAC), Amgen, Switzerland

Lucia joined Amgen as Director European Lead in Global Regulatory and R&D Policy in September 2018, after 12-year tenure at the European Medicines Agency. Lucia current roles focusses on advancing policy objectives related to the European regulatory environment. She represents Amgen in a number of EU trades associations working groups. In her most recent position at EMA, Lucia was part of the EMA SciRS Office; her work was instrumental to deliver the EMA Regulatory Science Strategy 2025. She covered several regulatory affairs management roles in pharma industry in the previous 9 years. Lucia is a biologist by training, holds a PhD in molecular biology from the University of Bologna and a Master in Regulatory Affairs.

Claudine  Sapède, PharmD

Claudine Sapède, PharmD

Director, Global HTA Policy, NOVARTIS INTERNATIONAL, Switzerland

Claudine Sapède is Director, Global HTA Policy at Novartis. In this role, she focuses on value assessment, HTA and reimbursement decision-making approaches and their impact on patient access to innovative treatments. She engages with internal and external stakeholders involved in shaping HTA, pricing and reimbursement decisions. Claudine is currently a member of the EFPIA market access and HTA working groups, leading the workstream related to the implementation of the EU HTA Reg. Prior to this, she had different roles in the field of pricing and market access, at country and global levels. Her career of over 20 y in the pharma sector spans the full spectrum of evidence generation, value demonstration, MA strategies, pricing, and policy.

Anja  Schiel, PhD

Anja Schiel, PhD

Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA, Norwegian Medicines Agency (NoMA), Norway

Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as special adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and just finished her 3-year term as Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA. She also leads the international HTA team at NoMA.

Bakhuti  Shengelia

Bakhuti Shengelia

Executive Director Global Policy and Healthcare Systems, Novartis, Switzerland

Currently coordinating Novartis’s engagement in global policy dialogue that affect cancer care & access to innovative cancer medicines, while leading internal capability building in healthcare system shaping & external engagement with key international stakeholders. Since joining NVS, he has been the main subject area expert in health policy & systems in the company. 20-year experience in global health, in WHO and World Bank where he worked on health system performance assessment and led health sector reforms in many countries. Also lead the Health System Strengthening & Immunization Financing Unit in Global Alliance for Vaccines and Immunization. MD degree & Masters in Health Policy & Management from Harvard School of Public Health.

Mira  Pavlovic, DrMed, MD, MS

Mira Pavlovic, DrMed, MD, MS

HTA Expert /Director/HTA Professor, NDA Advisory Services, Medicines Development and Training (MDT) Services, France

Mira Pavlovic is the Founder of Medicines Development and Training Services (Paris, France) and Associate Professor for Regulatory and HTA science at Lisbon University (Portugal). Mira consults on clinical drug development strategies for market access purposes as a member of the NDA Advisory Board, providing scientific advice and peer review of NDA reports at the request of pharmaceutical companies. She previously served as Head of Scientific Advice at the French Medicines Agency and a Vice-Chair of SAWP at the EMA. She was also Deputy Director for HTA and international affairs at the Haute Autorité de Santé, France, where she coordinated HTA early dialogues and work on common methodology of relative effectiveness assessment in Europe.

Niklas  Hedberg, MPharm

Niklas Hedberg, MPharm

HTACG Co-Chair & Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden

Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and reimbursement since 2001. Niklas started as a medical assessor and project leader in the agency, he was the Head of the Department for New Submissions between 2009 and 2014 and is since in his current position. Niklas has a broad experience of different aspects of value based evaluation and over time has seen the increasing importance for health technology assessment (HTA) both across health care systems and on local level to prepare accurate decision making.

Giovanni  Tafuri, PhD, MS

Giovanni Tafuri, PhD, MS

Senior Scientific Officer, EUnetHTA, Netherlands

Giovanni Tafuri is the Senior Scientific Officer of the European Network for Health Technology Assessment (EUnetHTA) at the EUnetHTA Secretariat in the Netherlands. Prior to his appointment, he worked at both the HTA and the regulatory department of the Italian Medicines Agency (2006-2018) and as Seconded National Expert in Scientific Advice at EMA (2015-2017). He is a pharmacist, MSc in “International Health Care Management, Economics and Policy” (Bocconi University), PhD in “Pharmaceutical Policy and Regulation” (University of Utrecht) and held research positions at different national and international institutions (World Health Organization, Mario Negri Institute for Pharmacological Research, Italian National Institute of Health).

Stephen  Moran

Stephen Moran

Project Manager, Wugen, United States

Ian  Rentsch, JD

Ian Rentsch, JD

CCO & GM Pharma , CENTOGENE GmbH, Germany

Ian Rentsch has over 25 years’ experience in Multinational Corporate Affairs, Outsourcing Management & Clinical Research Development working in large multinational companies including large biopharma and Contract Research Organizations Globally and in Emerging Markets. Most recent roles include General Executive Management, Leadership of regional clinical teams, Business Operations and Strategic Business Development in the Contract Research Industry & Clinical Technology.

Michael  Berntgen, PhD

Michael Berntgen, PhD

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands

Michael Berntgen, Head of Scientific Evidence Generation at the EMA, Amsterdam, oversees robust medicine development. Collaborating with stakeholders, the department provides scientific advice, supports pediatric and orphan diseases, and manages the PRIME scheme. Michael, a pharmacist with a PhD, worked in pharmaceutical regulatory affairs in Germany and the UK from 1999 to 2006. Joining BfArM in 2006, he moved to EMA in 2007, holding various positions until becoming Head of the department in March 2020.

Irena  Guzina, PharmD, MPH, MSc

Irena Guzina, PharmD, MPH, MSc

Medical Assessor, Coordinator of EUnetHTA WP5B PLEG Activities, HAS, France

Irena Guzina is a Pharmacist with a Master degree in Quality Control and Public Health. She has joined HAS in 2011, where she is working as Project manager at the Department for the Assessment of Medical Procedures. Moreover, Irena Guzina is also part of HAS EUnetHTA team. She is coordinating current WP5B activities on Post-Launch Evidence Generation.

Lenka  Kellermann

Lenka Kellermann

Managing Director, OncologyInformationService, Germany

Vanessa Elisabeth   Schaub

Vanessa Elisabeth Schaub

Global Access Senior Health Systems Strategy Leader HTA & Reimbursement, F. Hoffmann-La Roche, Switzerland

Vanessa Schaub is Global Access Strategy Leader for HTA & Reimbursement at Roche. In this role she is in charge of ensuring consistent approach to HTA systems, assessment methodologies, appropriate evidence application, value frameworks and innovative reimbursement schemes globally. Before taking over the global role she hold diverse access and commercial positions in the Roche German affiliate. Vanessa has experience in the departments of oncology, neurology and respiratory diseases.

Edith  Frénoy, MA, MSc

Edith Frénoy, MA, MSc

Director, European Public Policy – Strategic EU Advocacy Lead, MSD Europe Inc., Belgium

Flora  Giorgio, MPharm

Flora Giorgio, MPharm

Deputy Head of Unit Medical Devices, DG SANTE – Medical Products and Innovation, European Commission, Belgium

Flora is a pharmacist by training. She is heading the team of Health Technology Assessment at the European Commission in DG Health (SANTE), Unit "Medical devices and health technology assessment". The team is responsible for the Legislative Proposal on HTA, for the Secretariat to the HTA Network, and oversees the activities of the Joint Action EUnetHTA. Flora joined the EC in 2006 in DG CNECT, she worked in the ICT for the Health Unit. Before joining the EC she was the Secretary General of the PGEU, the European Association of Community pharmacists and also worked in a community pharmacy.

Peter  Mol, PharmD, PhD

Peter Mol, PharmD, PhD

CHMP member, NL, MEB, Netherlands

Peter Mol is the Dutch member of the Committee for Human Medicinal Products. He was a previous member (vice chair) of EMA’s Scientific Advice Working Party. He is co-chair of the EMA Cross-Committee Task force on Registries. He is also a professor of drug regulatory science at the University Medical Center Groningen. His research interest is in the area of regulatory science; from new tools to optimize regulatory decision-making (especially impact of personalised medicine and real world evidence), to improve knowledge transfer and with a specific interest in safety communication.

Erik  Sagdahl

Erik Sagdahl

Advisor, Norwegian Hospital Procurement Trust - Division of Pharmaceuticals, Norway

Education: Pharmacist (Master of Pharmacy) - University of Oslo Bachelor in Health Economics and Management – University of Oslo European Master of Health Economics and Management – Università di Bologna and University of Oslo Experience: Pharmaceutical industry and pharmacy wholesaler 6 years with the Norwegian Medicines Agency – department of pharmacoeconomics and HTA Currently working at the Norwegian Hospital Procurement Trust – Division of Pharmaceuticals. Responsibilities are procurement of cancer drugs

Judith  Creba, PhD

Judith Creba, PhD

Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU, Novartis Pharma AG, Switzerland

Judith Creba has many years experience in drug development, regulatory affairs and strategy at Novartis. She has worked in a range of therapeutic areas, including Oncology, Infectious Diseases, and Cardiovascular, before moving into EU Regulatory Policy where she has represented Novartis on a number of trade association committees. Judith is currently involved in clinical trials policy and is co-chair of the EFPIA Clinical Research Expert Group. She is also leading implementation of the new EU clinical trial regulation within Novartis.

Catherine  Cohet, PhD

Catherine Cohet, PhD

Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

Catherine is a senior pharmacoepidemiologist in the RWE Workstream, Data Analytics & Methods Task Force, at EMA. She previously held various pharma positions, generating and evaluating RWE across all phases of medicine development, including vaccines. She also worked as an epidemiologist at the Centre for Public Health Research and the Malaghan Institute for Medical Research in Wellington, New Zealand, and the WHO International Agency for Research on Cancer in Lyon, France. Her work at EMA focuses on international guidance on RWE, and on public health emergency preparedness as Steering Group member of the EU Vaccine Monitoring Platform. She is co-chair of the ENCePP Steering Group and represents EMA in various RWE-related ICH initiatives.

François  Houyez

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURORDIS), France

François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

Matteo  Scarabelli

Matteo Scarabelli

Patient Engagement Manager in HTA, EURORDIS, France

Kalitsa  Filioussi

Kalitsa Filioussi

European Market Access Director, Hematology, ORE, Novartis Oncology, Italy

Kalitsa Filioussi is an international Pharmaceutical Executive with over 17 year of experience at Country and European level. Currently she holts the position of the Director, Value and Access Region Europe at Novartis Oncology in Switzerland. She focuses on deploying the Access and Pricing Strategy for the Novartis Hematology Portfolio in the Region. Within this role she has the opportunity to interact and co-create with key stakeholders in Europe in the fields of the harmonized joint HTA assessment and evidence generation. Prior to this role, she has spent 12 years in various roles in Medical affairs and Clinical Development in Novartis and other Pharma Companies.

Ansgar  Hebborn, PhD, MBA

Ansgar Hebborn, PhD, MBA

Head - Access Policy Affairs Europe, F. Hoffmann-La Roche AG, Switzerland

Ansgar Hebborn is Roche Pharma's Head of Access Policy Affairs Europe. He represents Roche in relevant industry associations e.g. in Brussels as the chair of EFPIA’s European HTA Working Group. During the past few years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. EU HTA Network, EUnetHTA and the HTAi Policy Forum Committee, and also has been involved in the foundation of other initiatives in this field e.g. the Green Park Collaborative, the HTAi Asia Policy Forum and SwissHTA. In an earlier role as health economist and outcomes research specialist for Roche in the US, he has gathered extensive experience with real world data research.

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