3 A's Conference

April 29, 2021 · April 30, 2021

Conference

Availability, Accessability, Affordability of 

Medicines & Medical Devices

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The Ministry of Health and INFARMED - National Authority of Medicines and Health Products, I.P., in collaboration with the European Commission, will organise the 3As Conference to be held on the 29th-30th of April 2021, in Lisbon, via virtual form, under the Portuguese Presidency of the Council of the European Union.

One of the identified priorities by the Portuguese presidency is “Supporting Sustainable, Equitable and Universal Access to Medicines and Medical Devices”. This priority will be advanced by structuring discussions around 3 main pillars: Availability, Accessibility and Affordability. In this context, the conference aims to give a new and renewed momentum to the discussion on how to address these longstanding topics that have been on the agenda of those with the highest responsibilities in the European pharmaceutical policy. It is therefore necessary to continue this debate in the field of pharmaceutical policy at EU level, which addresses European and national developments and challenges in the various aspects of this subject in an integrated, ethical and sustainable manner.

Enhancing cooperation between EU countries is a key factor in the improvement of the accessibility, availability and affordability of medicines and medical devices. In this context, there shall also be a discussion on pricing and reimbursement policies, cost effectiveness of medicines, how public incentives are translated into the price of the product, regional collaborations, as well as the transparency throughout the value chain and the overall sustainability of health systems. It also looks for how ensuring access and accessibility when meeting needs and unmet needs and how to improve the market launch of centrally authorized products. In this sense, it would help improving accessibility, through a more equitable and adequate patient access to health technologies.

The 3As Conference aims to promote a multi-stakeholder debate on these specific issues pertaining to the identified topics that will inform collaborative approaches, define priorities and policy options to be translated into concrete action. It aims ultimately to contribute on promoting a European Health Union, through a larger and better cooperation between the different NCAs and stakeholders in the EU, namely, in the area of medicines and medical devices.

 

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Abstracts of the interventions

 

Presentations

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Marta Temido

Portuguese Minister for Health

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Marta Temido was born in Coimbra in 1974. She holds a PhD in International Health from the Institute of Hygiene and Tropical Medicine of the New University of Lisbon, as well as a Master's Degree in Health Economics and Management from the Faculty of Economics of the University of Coimbra and a Law Degree from the Faculty of Law of the University of Coimbra. Specialized in Hospital Administration by the National School of Public Health of the New University of Lisbon, she held the positions of deputy director of the Institute of Hygiene and Tropical Medicine of UNL and non-executive President of the board of the Portuguese Red Cross Hospital. From 2016 to 2017, she was President of the Executive Board of the Central Administration of the Health System. She was Minister of Health from October 2018 to October 2019.  She held management and administration responsibilities in several hospitals of the National Health Service, as well as other health-related entities. Namely, from 2013 to 2015 presided the Portuguese Association of Hospital Administrators. Marta Temido was also member of the advisory board of the Grupo de Ativistas pelo Tratamento (GAT) and of the Institute of Hygiene and Tropical Medicine.She taught in several health institutions and is the author and co-author of scientific publications on health.

Tedros Adhanom Ghebreyesus

WHO Director-General

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Dr Tedros Adhanom Ghebreyesus was elected WHO Director-General for a five-year term by WHO Member States at the Seventieth World Health Assembly in May 2017. In doing so, he was the first WHO Director-General elected from among multiple candidates by the World Health Assembly and was the first person from the WHO African Region to head the world’s leading public health agency.  As Minister of Health from 2005 to 2012, he led a comprehensive reform of the country’s health system, built on the foundation of universal health coverage and provision of services to all people, even in the most remote areas. Under his leadership, Ethiopia expanded its health infrastructure, developed innovative health financing mechanisms, and expanded its health workforce. A major component of reforms he drove was the creation of a primary health care extension programme that deployed 40 000 female health workers throughout the country. A significant result was an approximate 60% reduction in child and maternal mortality compared to 2000 levels. As Minister of Foreign Affairs from 2012 to 2016, he elevated health as a political issue nationally, regionally and globally. In this role, he led efforts to negotiate the Addis Ababa Action Agenda, in which 193 countries committed to the financing necessary to achieve the Sustainable Development Goals. Prior to his election as Director-General of WHO, Dr Tedros held many leadership positions in global health, including as Chair of the Global Fund to Fight AIDS, Tuberculosis, and Malaria, Chair of the Roll Back Malaria Partnership, and Co-chair of the Partnership for Maternal, Newborn and Child Health Board. After taking office as WHO Director-General on 1 July 2017, Dr Tedros initiated the most significant transformation in the Organization’s history, which has generated a wide range of achievements.

Stella Kyriakides

European Commissioner for Health and Food Safety

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In her capacity as the European Commissioner for Health and Food Safety since December 2019, Ms Kyrriakides is leading the Commission’s work on various portfolios including the Europe’s Beating Cancer Plan, aiming to improve cancer prevention and care while also she is in charge of developing a new Pharmaceutical Strategy to ensure that Europe can meet its needs relating to affordable medicines. During the COVID-19 crisis, the Commissioner took on the responsibilities of coordinating the EU’s health response and of supporting Member States to tackle the outbreak. Ms. Kyriakides has previously worked as a clinical psychologist for 28 consecutive years, in the Mental Health Services of the Ministry of Health of the Republic of Cyprus in the area of Child and Adolescent Psychiatry, from 1979-2006. Ms. Kyriakides was elected to the Cyprus Parliament in 2006 and was then re-elected in 2011 and 2016 for the Democratic Rally Party, for which she served duties as Vice-President. In 2012, Ms. Kyriakides was appointed Head of the Cyprus Delegation to the Parliamentary Assembly of the Council of Europe (PACE) and in 2017 she was elected as President of PACE, thus becoming the 30th President of the Assembly.

Dolors Montserrat

Member of European Parliament, ENVI Committee

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Dolors Montserrat is a Member of the European Parliament since 2019. Amongst her parliamentary activities in Brussels is the membership of the Committee on the Environment, Public Health and Food Safety, the Special Committee on Beating Cancer and Head of the EPP Spanish Delegation. She is also a member of the EP Conference of Committee Chairs, and she chairs the Committee on Petitions. She has also served as Minister of Health, Social Services and Equality of Spain from 2016 to 2018. In addition, she has also been Member of the Congress of Deputies in the Cortes Generales between 2008 and 2019 by Barcelona. She was a practicing Lawyer from 1997 to 2011, specialized in civil, property and family law, attended the C.O.U in the United States (Memphis, Tennessee), has a Postgraduate in Urban and Real Estate Law taught by Pompeu Fabra University and a Postgraduate in Family Mediation and contractual negotiation taught by the University of Barcelona.

Rui Santos Ivo

President of Portugal's INFARMED

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Rui Santos Ivo is currently President of INFARMED – National Authority of Medicines and Health Products, I.P., since June 2019. Member of the Management Board of the EMA, since March 2016. Member of the Executive Board of EUnetHTA - the European Network for Health Technology Assessment, since June 2016. Vice-chair of the Valletta Permanent Technical Committee/Valletta Declaration, since July 2017. He is also an Invited Assistant Professor of Medicines Regulation, at the Faculty of Pharmacy of the University of Lisbon, where he is a member of the School Council. He is an external elected member of the General Council of the University of Coimbra, since 2017. Previously he was President (2014/2016) and Vice-President (2011/2014) of the Central Administration of the Health System (ACSS,IP) at the Ministry of Health, in Portugal. He was Coordinator of the Hospital Reform Project Team (2012/2015) and chaired the Governance College for the Public Health Subsystems (2015/2016). Santos Ivo initiated his professional career as a hospital pharmacist at Hospital de Egas Moniz, in Lisbon. In 1993 he joined INFARMED, where he held various responsibilities, namely vice-president (1994-2000; 2016-2019) and President (2002-2005). In 2000 and 2002 he worked as Administrator at the Directorate of the European Medicines Agency (EMA), in London, and in 2006 and 2008 he worked for the European Commission as Administrator at the Pharmaceuticals Unit, Directorate General for Enterprise and Industry, in Brussels. He was a member of the Management Board of the EMA (2002/2005) and the first Chairman of the European Union Heads of Medicines Agencies Management Group (2004-2005). Between 2008 and 2011 he was Executive Director of the Portuguese Association of the Pharmaceutical Industry (APIFARMA).

Christa Wirthumer-Hoche

Head of Austrian Medicines and Medical Devices Agency

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Besides is role at the Austrian Medicines and Medical Devices Agency, he is also Chair of the Austrian Scientific Board since 2009. Member of the EMA-Management Board (topic coordinator for the AR of the EMA annual activity report and for the report on the annual EMA Budget from 03/14 - 12/15) since 03/2016 Chair of the EMA-Management Board HMA full member (HMA alternate 2000 - Oct. 2013) Co-Chair of the EU-Training Network Centre Member of the Pharmaceutical Committee. Until 2013 he was Head of Institute for Marketing Authorisation of Medicinal Products. He was a member of the CMDh (Nov 2005 - Oct. 2013) and Chair of the ASMF-Working Group. He was also a member of the European Risk Management Strategy Facilitation Group (ERMS-FG) 10/2010 - 10/2013. Until 2005 he was Head of Unit for Pharmaceutical Affairs of the Federal Ministry of Health (Austria).

Andrzej Rys

Director for Health Systems and Products of the EC

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Andrzej Rys is a medical doctor (radiology and public health) graduated from Jagiellonian University (JU) Krakow (PL). In 1991 established a School of Public Health at the JU. SPH’s Director till 1997. In 1997 to 1999 he was appointed as Krakow’s city Health Department Director. In 1999 till 2002 he was appointed as Health Deputy Minister (PL). He is a member of the Polish accession negotiators team. In 2003 established and ran as Director the Center for Innovation and Technology Transfer at JU. In 2006 joined the EC as Public Health and Risk Assessment Director in the Directorate-General for Health and Consumers in LUX. In 2011 he was appointed as Director for the directorate of Health Systems, medical products and innovation in the Directorate-General for Health and Food Safety in Brussels.

Nuno Simões

Director of interinstitutional and health system projects at INFARMED

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Nuno Simões is director of interinstitutional and health system projects at INFARMED since April 2020. Previously worked as head of unit for executive support, communication and information at the Central Administration of the Health System. Between 2018 and 2019 national representative at the EU Social Protection Committee. He was advisor of the Executive Board of INFARMED from 2003 to 2012 and member of the permanent secretariat of the Heads of Medicines Agencies Management Group between 2007 and 2012. He has a license in international relations, master in Political Science and post graduate studies on European studies and political journalism. National defence course at the Instituto de Defesa Nacional in 2019.

Noël Wathion

Deputy Executive Director of EMA

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Noël Wathion is the Deputy Executive Director of EMA (European Medicines Agency) since 1 February 2016. He also exercises the function of Chief of Policy. He is the Chair of the EMA ORP (Operations and Relocation Preparedness) Task Force, set up since June 2016 following the United Kingdom’s decision to leave the European Union, responsible for overseeing all Brexit consequences for the Agency and coordinating the Agency’s response, including the Agency’s relocation from London to Amsterdam. He is also the Chair of the Agency’s COVID-19 Steering Group, set up in March 2020 to coordinate the Agency’s activities related to the COVID-19 pandemic, hereby ensuring EMA’s preparedness for any possible scenario during the pandemic. He joined the Agency in August 1996 and was appointed over the past 20 years to several senior managerial positions. He is a qualified pharmacist from the Free University of Brussels (VUB).

Josipa Cvek

Croatian Agency for Medicinal Products and Medical Devices (HALMED)

cvek.jpgJosipa Cvek, is a Senior Advisor for Distribution of Medicines in Croatian Agency for Medicinal Products and Medical Devices (HALMED). Dr. Cvek has a University Degree and PhD in Pharmaceutical Science from Faculty of Pharmacy and Biochemistry, University of Zagreb, Croatia. In 2020, Dr. Cvek was nominated as a NCA SPOC person and she is actively involved in activities within the EU regulatory network related to shortages of critical medicines.

Kristin Raudsepp

Director General of the Estonian State Agency of Medicines

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Kristin Raudsepp is a graduate of the University in Tartu as a physician - general practitioner. She has been working in the Estonian drug regulatory agency from 1994, from 2002 Director General of the Estonian State Agency of Medicines, and is also the estonian representative in the EMA Management Board since 2004, the representative in the Pharmaceutical Committee, European Commission, an Expert for World Health Organization in the field of regulation of medicinal products (2011, 2013) and Co-chair of the HMA/EMA Task Force of the availability of authorised medicines (TF AAM). Kristin Raudsepp has been the leader in international working groups (Heads of Medicines Agencies, Task Force of Availability of Medicinal products, HMA/EMA strategy 2020 lead for priority theme Availability of appropriately authorised medicinal products), theme leader and member of the organizational committee of international conferences (DIA Euromeeting, ICDRA, PERF), team leader of international working groups (Heads of Medicines Agencies Management Group) and is having lots of experience as a speaker and session chair at international conferences.

Hugues Malonne

Federal Agency for Medicines and Health Products

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Hugues Malonne, has more than 25 years of experience in mature and emerging markets delivering significant business results through Market Access, Public - Private Partnerships, Medical and Governmental affairs initiatives. Strong R&D background in oncology, pain and supportive care as well as modified-release dosage forms. Extensive academic experience in pharmacokinetics & pharmacodynamics, pharmaceutical technology, clinical pharmacy, ethics and pharmaceutical regulation (registration and market access). He is Director-General of FAMHP, the Belgian competent authority for the quality, safety and efficacy of medicines and health products, since 2017. The DG Post Authorization (>150 FTEs) is in charge of all the activities taking place after the first marketing authorisation for a medicine or a healthcare product. The DG regroups 4 divisions: The Post Authorization Division, the Vigilance Division, the Healthcare Products Division (MD & IVD) and the Proper Use Division. NON-EXECUTIVE DIRECTOR, Board of Directors, LIH, Luxembourg Jan 2015- Dec 2019. In January 2015, the Integrated Biobank of Luxembourg and the Centre de Recherche Public- Santé were merged into a new entity called Luxembourg Institute of Health. The Luxembourg Institute of Health is a Public Research Centre under the "Loi du 03 décembre 2014 ayant pour objet l'organisation des centres de recherche publics". The Board of Directors oversees both IBBL and former CRP-Santé activities.

 

Aida Batista

Vice-President of the European Association of Hospital Pharmacists

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Aida Batista is a Degree in Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon (1987). Specialization in Hospital Pharmacy (1994), has a Postgraduate Course in Management and Leading of Health Services, Faculty of Economics, University of Porto (2006). She is a Hospital Pharmacist since 1987, Senior Pharmacist, Centro Hospitalar de Vila Nova de Gaia (CHVNG/E) (since 2003), Member of Drug and Therapeutic Committee, CHVNG/E, (2004-2019) and Director of Pharmacy Department, CHVNG/E, (2013 -2019). She was Board Member of the Portuguese Association of Hospital Pharmacists - APFH (2002-2005) and President of APFH, (2008- January 2015). She is EAHP Vice-President since June 2017. The work for the European Association of Hospital Pharmacists focuses mainly on patient safety, medicines shortages, medical devices, hazard.

Monique Goyens

Director General of BEUC

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As Director General of BEUC, Monique Goyens represents 45 independent national consumer associations in 32 European countries, acting as a strong consumer voice in Brussels, ensuring that consumer interests are given weight in the development of policies and raising the visibility and effectiveness of the consumer movement through lobbying EU institutions and media contacts. As a consumer expert and advocate, and on behalf of BEUC, Monique is a member of the EU Platform on Sustainable Finance and of the Euro Retail Payments Board. She is Vice-Chair of the European Advisory Board of the Open Society Foundations. She is also a member of the Advisory Group on Noncommunicable Diseases of WHO-Region Europe. Since March 2021 she is a member of the Consumer Policy Advisory Group, DG Justice. Previously, she was a member of the expert group on “Online Disinformation” (2018), of the expert group on “trade agreements” (2018-2019), the EU High Level Forum for the Capital Market Union (2020) and sub-group on Artificial Intelligence, Connected Products and other new Challenges in Product Safety (2020). In her capacity as BEUC Director General, Monique is currently EU co-chair of the Transatlantic Consumer Dialogue (TACD) a network of EU and US consumer organisations, and she also represents BEUC at Consumers International, the international consumer organisation. 

Karl Broich

President of Germany's Federal Institute for Drugs and Medical Devices

broich-oradores-750x400.jpgProf. Dr. med.Karl Broich absolved a Study of Human Medicine at the Medical Faculty of the Rheinische-Friedrich-Wilhelms-Universität Bonn. Since 2014, Karl Broich is President of the Federal Institute for Drugs and Medical Devices in Bonn. His current activities in the European network of regulatory authorities are member of the European Medicines Agency’s Management Board (EMA MB) and Chair of the EU Telematics Management Board (EU TMB). In addition, he is member of the Heads of Medicines Agencies (HMA) Management Group; since March 2021, he also took over the role as Chair of the HMA Management Group. His scientific focus is clinical psychopharmacology; advanced imaging in neurodegenerative diseases, biomarkers, dementia, and methodology of clinical trials. In addition, Karl Broich is author and co-author of over 190 essays (original scientific papers, reviews, book contributions).

Emer Cooke

Executive Director of the European Medicines Agency (EMA)

emer-oradores-750x400.jpgEmer Cooke is as of 16 November 2020 the new Executive Director of the European Medicines Agency, based in Amsterdam. She also takes the role of Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) for a term of 2 years. She was the Director responsible for all medical product-related regulatory activities at the World Health Organization in Geneva between November 2016 and November 2020. In this role, Ms Cooke was responsible for leading WHO's global work on regulation of health technologies (medicines, vaccines, diagnostics, vector control products and devices), coordinating the regulatory teams (Prequalification, Regulatory Systems Strengthening, and Safety), and working with member states and international partners to assure the quality, safety and efficacy of appropriate health technologies. Ms. Cooke is a pharmacist with Masters degrees in Science and Business Administration from Trinity College Dublin. She has over 30 years’ experience in international regulatory affairs and spent 14 years (2002 to 2016) in management positions at the European Medicines Agency as Head of Inspections and Head of International Affairs respectively. From September 1998 to July 2002, she worked in the Pharmaceuticals unit of the European Commission.

Svens Henkuzens

Director of the Latvian State Agency of Medicines

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Svens Henkuzens is the Director of the Latvian State Agency of Medicines since 2015. He joined the Heads of Medicines Agencies (HMA) Management Group in 2019. He was for a brief period Deputy Head of the Department of Investments and Monitoring of the European Union Funds at the Ministry of Health. During 2015 he was Chair of the European Union Council Working Group on Pharmaceuticals and Medical Devices. Before that he was the Health and Pharmaceuticals Attaché at the Permanent Representation of Latvia to the European Union. He has a bachelor's degree in European Public Health from Maastricht University and a master’s degree in Healthcare Policy, Innovation and Management from the same University.

Helena Fonseca

PDCO member

fonseca-oradores-750x400.jpgHelena Fonseca is a Associate Professor with Habilitation in Pediatrics in the Faculty of Medicine, University of Lisbon. She is also a PDCO member of EMA, a senior Consultant at the Department of Pediatrics, Hospital Santa Maria, Head Adolescent Medicine Division and Coordinator Pediatric Obesity Clinic at Lisbon Academic Medical Centre (CAML).

Violeta Stoyanova-Beninska

Chair of the Committee for Orphan Medicinal Products

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Violeta Stoyanova-Beninska is Chair of the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) since 2018. Before that she has been member of the COMP representing The Netherlands, Chair of the National Scientific and Regulatory Advice at the Medicines Evaluation Board, member of CNS working party and Scientific advice working party at EMA. She is also member of scientific and advisory boards of international projects related to rare diseases, personalized medicine and orphan drug development. Along with the regulatory work, Violeta is active as an academic being supervisor of PhD and master students, guest lecturer at several universities, member of editorial board/reviewer panel in scientific journals.

Marco Greco

President of the European Patients Forum

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Dr Marco Greco currently sits on the Management Board of the European Medicines Agency (EMA) and acts as an observer on the Patients and Consumers Working Party (PCWP), on behalf of the Board. He works as an attorney at his law firm, focusing on litigation, commerce and consumers’ protection legislation. He has been chairman of the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) and the founder of the EFCCA Youth Group. After an LL.MM in Law, he earned a PhD in Law and Religion, religious freedom and discrimination and cannon law at Università Cattolica del Sacro Cuore in Milano, where he still collaborates with the Chair of History and Systems of Church-State relationships.

César Hernández

Head of the Department of Medicines for Human Use

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MD, PhD, specialist in rheumatology. Head of the Department of Medicines for Human Use at the Spanish Agency for Medicines and Medical Devices.

Xavier Kurz

Head of Data Analytics Workstream of EMA

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Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia.  He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada.  He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently Head of Data Analytics within the Data Analysis and Methods Task Force.

Nikolai Brun

Director of Division at Danish Medicines Agency

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MD, PhD Nikolai C. Brun, has background and experience in the clinical field and afterward in research and development of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years with a long list of publications in high-impact journals. He has worked for 4 years as Director of Division responsible for Medical Evaluation and Biostatistics – both Human and Veterinary Medical Evaluation, Danish Medicines Agency. As of 1st of January 2021 Director of Division responsible for Medical Strategy and Innovation, Danish Medicines Agency. he is Co-Chair of the joint HMA/EMA Big Data Steering Group. Member of the Board of Directors, Copenhagen Centre for Regulatory Science, University of Copenhagen Member of the Scientific Advisory Board, EHDEN, European Health Data Evidence Network.

Maria Lamas

Executive Director of the Spanish Agency of Medicines and Medical Devices

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Maria Lamas is the Executive Director, Spanish Agency of Medicines and Medical Devices (Spain) since 2018. From 2013 until 2018 she was Chief of the Pharmacy Department, Xerencia de Xestión Integrada of Santiago de Compostela. Before that she was the Area Coordinator of “Platforms and methodology”, Institute of Health Research (IDIS) of Santiago de Compostela and responsible for the Oncology Pharmacy Unit Oncology Pharmacy Unit XXI of Santiago de Compostela. She was also the Research Director Spanish Society of Hospital Pharmacy and Senior Clinical Pharmacist Conxo Hospital (Santiago de Compostela)

Anna-Eva Ampelas

Head of Unit for Medical Devices and HTA at DG SANTE

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Anna-Eva Ampelas is Head of Unit for Medical Devices and Health Technology Assessment in Unit B6 in DG SANTE, European Commission. In this capacity, she is managing files on medical devices, including in vitro diagnostic medical devices, and Health Technology Assessments (HTA). She has almost fifteen years of experience working on health policy and legislation in the European Commission and five years in managerial positions in the Commission. Before taking over the Unit on Medical Devices, Anna-Eva was heading units dealing with pharmaceuticals, substances of human origin, tobacco control and global health.  She was Health Counsellor at the Permanent Representation of Sweden 2002-2006 before joining the European Commission. Anna-Eva has a Master of Laws from Uppsala University.

Thomas Wejs Møller

Chair of the Competent Authorities (CAMD)

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Thomas Wejs Møller is Head of medical device division in the Danish Medicines Agency and Chair of the competent authorities (CAMD).

Niall MacAleenan

Health Products Regulatory Authority of Ireland

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Niall MacAleenan is the Director of Medical Devices at the Health Products Regulatory Authority (HPRA) in Ireland. As a member of the HPRA’s senior management team, he is responsible for the operation and development of HPRA’s regulatory activities and capabilities for medical devices and leadership of its Medical Device Department. His work over the next number of years will focus on ensuring effective operation and consistent application of the new EU Regulations on medical devices and optimising the HPRA activities for medical devices. 
Niall MacAleenan qualified as a medical doctor at Trinity College Dublin in 1999. Niall worked in a variety of clinical and research roles across the Irish health care system. He also attained a business degree from University College Dublin. Since joining HPRA Niall has held a variety of different roles at senior level within the organisation both in the area of medical devices and human medicines. In 2018, Niall was appointed as the Head of Medical Devices to establish and lead the HPRA’s new medical devices department.
 Niall is a leading European expert on medical devices. He represents HPRA and Ireland at the EU Medical Device Coordination Group (MDCG), the EU Regulatory Committee, the Executive Group of the Competent Authorities for Medical Devices (CAMD) network and, when required, at the European Council’s Working Party on Pharmaceuticals and Medical Devices. Niall is also a member of the European delegation to the Management Committee of the International Medical Device Regulators Forum (IMDRF). 

Sylvain Giraud

Head of Unit Medical products: quality, safety and innovation at DG SANTE

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Sylvain Giraud is since last year the Head of Unit “Medical products: quality, safety and innovation” in the Directorate General for Health and Food Safety of the European Commission (DG SANTE). The unit is in charge of EU level policy developments on quality, availability and affordability of medicines and supervises important aspects of the implementation of EU legislation, the implementation of the Pharmaceutical Strategy for Europe and the coordination of international cooperation on medicines policy.  In previous Head of Unit positions in DG SANTE  in the last 10 years Sylvain has been dealing with Health Systems, global health and EU health policy coordination.

Pedro Pita Barros

Professor of Health Economics at Nova School of Business of Economics

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Pedro Pita Barros is a Professor of Health Economics at Nova School of Business of Economics, Universidade Nova de Lisboa. He is a member of the European Commission’s “Expert panel on effective ways of investing in health”, a member of the Portuguese National Council of Ethics for the Life Sciences, a member of Portuguese National Health Council, Past-President of the Portuguese Association of Health Economics, and Past-President of the European Association of Health Economics. His research focuses on health economics and on regulation and competition policy and appeared in many academic journals. Pedro Pita Barros has also several books on health economics (in Portuguese and English). He served as Member of the Board of the Portuguese Energy Regulator (2005/2006), on the Governmental Commission for the Financial Sustainability of the National Health Service (2006/2007) and on European Commission Mission Board for Cancer (2019-2020). Pedro Pita Barros served as vice-rector of Universidade Nova de Lisboa (2013-2017). He serves on the editorial boards of academic journals in the field of Health Economics. He acted as consultant for both private and public entities, in Portugal and at the European level, in the areas of health economics, competition policy and economic regulation.

Francisco Ramos

Professor at National School of Public Health

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Francisco Ramos has a Degree in Economics, ISCTE – Instituto Universitário de Lisboa (University Institute of Lisbon), Portugal, 1978, with a Specialization Course of Hospital Administration, Escola Nacional de Saúde Pública. He is the President of the Board of the Hospital Cruz Vermelha, since 2020, and Associated Professor of Health Economics of the Group of Social Sciences Disciplines at the Escola Nacional de Saúde Pública, Universidade Nova de Lisboa, since 1987. He was Deputy Minister for Health of the XXI (2018-2019) and XVII (2008/2009) Constitutional Government. he was also President of the Board of the Portuguese Institute of Oncology of Lisbon Francisco Gentil and Chairman of the board of directors of the Instituto Nacional de Administração, INA (National Administration Institute), 2009/2012. Before that he was Deputy Director-General of Health and Deputy Director-General of the Health Studies and Planning Department (1997).

Marcel van Raaij

Director of Pharmaceutical Affairs and Medical Technology in Netherlands

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Since October 2014 Marcel van Raaij is the Director of Pharmaceutical Affairs and Medical Technology at the Ministry of Health in the Netherlands. The Directorate is responsible for the policy making on pharmaceuticals (from innovation, market access, safe use to pricing and reimbursement), medical devices and technology and tissues and cells including organ donation policy. The Netherlands presented a new Pharma policy in January 2016 and proposed an active agenda on pharmaceutical policy during the Dutch Presidency of EU council in 2016. From 2016 until May 2019 Marcel van Raaij was the first chairman of the Steering Committee of the BeNeLuxA initiative where The Netherlands, Belgium, Luxembourg, Austria and Ireland are working together on sustainable access to medicines in their countries. After his PhD he moved to the National Institute of Public Health and Environment (RIVM). He worked in the toxicological risk assessment and was active in various international working groups and commissions (EU,WHO, OECD, US EPA). He became acting director for Nutrition, Medicines and Consumer Safety. From 2011 to 2014 he was Director of Environment and Safety at RIVM dealing with environmental policy and physical safety including preparedness and response activities.

Momir Radulović

Director of Slovenian Medicines and Medical Devices Agency

radulovic-oradores-750x400.jpgMomir Radulović leads the Slovenian Medicines and Medical Devices Agency since December 2018. He is a member EMA Management Board, a member of EC Pharmaceutical Committee and a member of High-level Group on the Health Emergency Preparedness and Response Authority. His previous work experience includes Hospital and Community Pharmacy and Pharma industry, where his work focused on oncology medicines, HIV and vaccines.  By living in 6 and working in 10 different countries with diverse health systems and cultural environments and through different work areas, projects, and assignments he has learned to adapt swiftly to changes and to seize the opportunities that those can offer.

Nathalie Moll

European Federation of Pharmaceutical Industries and Associations

nathalie-750x400.jpgNathalie Moll joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) as Director General in April 2017. EFPIA represents the pharmaceutical industry operating in Europe. Together with its direct membership 40 leading pharmaceutical companies, 33 national associations representing over 1,900 companies and in collaboration with health and research players, EFPIA's mission is to create an environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. Prior to joining EFPIA, between 2010 and 2017 Nathalie was the Secretary General of EuropaBio ranked as the most effective European Trade Association in Brussels in 2013. She spent over 20 years working for the biotech industry at EU and national level in associations and corporate positions and held the position of Chair and Vice Chair of the International Council of Biotech Associations (ICBA). In 2013, Nathalie won the Technovisionaries Women Innovation Award organised by Women & Technologies while in 2009, Nathalie and the Green Biotech Team of EuropaBio were presented with the Leadership and Excellence in Advancing Ag-Biotech and Food Issues Award. Nathalie was also named one of the 15 leading women in biotech in Europe in 2017. Nathalie holds an Honours Degree in Biochemistry and Biotechnology from St Andrews University, Scotland.

Christoph Stoller

President of Medicines for Europe

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Christoph Stoller has been a member of the Board as well as of the Executive Committee of Medicines for Europe, the European committee for generics and biosimilar companies, responsible for nearly 70 % of the pharmaceutical supply in Europe, since 2014. Furthermore, he has been pivotal in setting up the sector group on Value Added Medicines and chaired that sector group until 2017. In his current role as General Manager for Teva´s cluster Germany & Austria, he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017, he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role, he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph has been working for Teva Europe in various roles with increasing responsibility since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re.

Serge Bernasconi

Medtech Europe

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Mr Bernasconi has 40 years’ experience in the world of pharmaceuticals, medical technology and trade association leadership.  He has worked in senior leadership position in companies such as Johnson & Johnson, Schering Plough (now Merck), and Medtronic. He has exercised his leadership in various geographical areas around the world, including, the US, Europe (France, Italy, Belgium, Switzerland), Turkey, the Middle East and Africa. Throughout his career he has been involved in trade association activities and responsibilities both for the pharmaceutical industry and the MedTech Industry. Prior to become the CEO of Eucomed and EDMA and then MedTech Europe, he had been elected President of APIDIM (The French Association for the Promotion of Innovation in Medical Devices), and Vice President and Treasurer of SNITEM (French Medical Technology Industry Association).

Monika Derecque-Pois

Director General of GIRP

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Monika Derecque-Pois is the Director General of GIRP, the European Healthcare Distribution Association, which brings together over 750 pharmaceutical full-line wholesaling companies and their national associations from 34 countries. Monika was appointed to her current position in 2001, having previously served as European Affairs Consultant for GIRP. Monika Derecque-Pois was born in Graz/Austria and holds a master’s degree in Economics from the University of Economics in Vienna, where she specialised in International Trade and Marketing. She has over 25 years of experience in European public affairs and healthcare distribution. Prior to her engagement with GIRP, she served as a director in a European affairs consultancy company, and she also held a six-year post as Marketing and Client Support Manager at IQVIA Austria.

Yannis Natsis

Policy Manager at European Public Health Alliance

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Yannis Natsis currently leads the advocacy for better and affordable medicines at the European Public Health Alliance (EPHA), the leading public health stakeholder in Brussels. Before joining EPHA in January 2016, he worked at the European Parliament, the Greek Ministry of Foreign Affairs, the UN and the private sector in Brussels and Athens. Between 2013-2015, Yannis was Advocacy Advisor for the TransAtlantic Consumer Dialogue (TACD) focusing on access to medicines. Between 2006-2010, he was an investigative reporter for Greece’s award-winning TV news programme “Fakeli” and a contributor to the Greek daily “Kathimerini”. He has a Master’s degree in International Conflict Analysis from the University of Kent, UK and a Bachelor’s degree in European Studies from Pantion University of Social and Political Sciences, Greece. A Greek national, he is fluent in Greek, English and French. Yannis is committed to fighting for transparency, accountability and defending the public interest in health and medicines policies.

Annabel Seebohm

Secretary General of the Standing Committee of European Doctors

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Prior to joining CPME in 2016, Annabel was head of the Brussels office of the German Medical Association (GMA) and legal advisor in the joint legal department of the GMA and the National Association of Statutory Health Insurance Physicians (NASHIP). From 2007 to 2016 she was also general counsel of the World Medical Association (WMA).  Annabel studied law at the University of Bonn, undertook her judicial service training in Hamburg and obtained a Masters’ degree from the University of Auckland, New Zealand. She is admitted to the Berlin Bar and a Member of SCIANA, the Health Leaders Network.

Ilaria Passarani

Secretary General of PGEU

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Ilaria Passarani is Secretary General of PGEU, the organization representing European community pharmacists. She provides strategic direction and leadership to the organization while managing the day to day operations of PGEU, its ongoing relationships with member associations and other stakeholders, as well as representing the pharmacy sector in various European and national fora. She is Vice-President and member of the Board of Directors of EMVO, the European Medicines Verification Organization. Before joining PGEU Dr. Passarani worked as Head of the food and health Department at the European Consumer Organization BEUC. She also served as a member of the European Medicines Agency (EMA) Management Board. She graduated cum laude in Economics from Bocconi University (Italy) and holds a PhD from the Faculty of Health, Medicine and Life Sciences at the Maastricht University (The Netherlands).

Diogo Serras Lopes

Portuguese Secretary of State for Health

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Diogo Serras Lopes is the Secretary of State for Health since September, 2020. With a degree in Economics by the Business School of Universidade Nova de Lisboa, he also attended the Masters in Political Sciences at the Instituto Superior das Ciências do Trabalho e da Empresa – Instituto Universitário de Lisboa. He’s also, since 2005, CFA Charterholder (CFA Institute). He began his professional path in 1998, as a journalist at the Economia Pura Magazine, and, from 1999 to 2014, also worked in asset management in a series of private institutions such as MC Fundos, Santander Asset Management and Banco Best. From May 2014 to November 2015, he worked in the Regulatory Policy and International Affairs Department at Comissão do Mercado de Valores Mobiliários (Portuguese Securities Market Commission). From December 2015 to August 2017, he was also adviser to the Secretary of State Assistant to the Prime Minister and from August 2017 to April 2019, he was appointed adviser for economical affairs to the Prime-Minister, in the first Government of Prime Minister António Costa. From April 2019 to September 2020, he was Vice President at the Central Administration of the Health System (ACSS).

 
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