Curriculum-Vitae

Professional

2004 European Commissioner
2002 – 2004 Minister for European Affairs for Slovenia
1998 – 2004 Head of negotiating team for the accession of Slovenia to the EU
2001 – 2002 Minister Councillor at the Slovenian Prime Minister's Cabinet
1993 – 2001 Director at the Institute of Macroeconomic Analysis and Development in Ljubljana
1988 – 1993 Senior researcher at the Institute for Economic Research in Ljubljana
1984 – 1987 Assistant Director at the Institute of Macroeconomic Analysis and Development in Ljubljana

Education

1993 PhD in Economics, Faculty of Economics at the University of Ljubljana

Dr Rainer Gerold is Director of the Research DG’s ‘Science and Society’ directorate. He has been working for the European Commission's Directorate-General for Science, Research and Development since 1982. Between 1982 and 1992 he was responsible for budget and personnel and research contracts, before becoming the director responsible for co-operation with third countries and international organisations (1992-1998). In 1999-2000 he headed up the Life Sciences I directorate.

Dr Gerold studied law and economics at the University of Bonn and obtained his PhD in international law. He worked at the Oberlandesgericht (regional court of appeal) in Cologne from 1965 to 1969 then, in 1970, he joined the Federal Ministry for Research and Technology in Bonn where he became assistant to the State Secretary (1972-1974). In 1974 he moved to CERN in Geneva to take up the position of assistant to the Director-General as well as secretary of the CERN directorate. In 1978 he became administrative director of the GSF (National Research Centre for Environment and Health) in Munich, remaining there until 1982 when he moved to the European Commission.

Hermann Amstad, MD, MPH, is the deputy secretary-general of the Swiss Academy of Medical Sciences. Between 1999-2000 he was a member of the Research Ethics Committee of the Swiss Academy of Medical Sciences. He is currently responsible for the “StaR” Working Group which comprises representatives of ethics committees of the Swiss Federal Office of Public Health, the Swiss Agency of Therapeutic Products, and the Swiss Society of Bioethics. This group develops courses for EC members. Dr Amstad also initiated the internet platform www.swissethics.ch which is the website of the Swiss Ethics Committees.

Christian Andersen (born 1964) has written about health care politics almost all of his career as a professional journalist. He is a journalist at the weekly Journal of The Danish Medical Association, but has among other things also worked as a journalist at the journal of the Danish Nurses Organization and in a public relations office for the pharmaceutical industry. He is a skilled journalist from the Danish School of Journalism, has studied Danish language and literature at the University of Copenhagen and is about to finish a diploma course in strategic communication at University of Southern Denmark/Centre for Journalism and Further Studies. Member of Danish Science Journalists Association.

Cristina Avendaño-Sola

Born in Barcelona in 1961, Dr Avendaño-Sola received an MD in 1985 and has been specialising in clinical pharmacology since 1990. She is responsible for the Clinical Pharmacology Unit at the University Hospital Puerta de Hierro in Madrid and Associate Professor of Clinical Pharmacology at the Autonomous University of Madrid. She is an expert at the European Medicines Agency, participating in the clinical evaluation of new medicines and in the development of guidelines on clinical trials in different diseases.

Dr Avendaño-Sola was involved in the development of the European Directive on clinical trials with medicines, as well as in the Spanish regulation. She is currently chairperson of the Research Ethics Committee of the 6th Area in Madrid.

Alex Capron is the first Director of Ethics, Trade, Human Rights and Health Law at the World Health Organisation in Geneva, Switzerland. He joined the WHO in October 2002 to establish the ethics and health unit in the Director-General’s Office. He previously taught law, medicine, and ethics at Georgetown, Pennsylvania, Yale and, most recently, at the University of Southern California where he was University Professor, Henry W. Bruce Professor of Equity, Professor of Law and Medicine, and Co-Director of the Pacific Center for Health Policy and Ethics. From 1979-1983 he served as the executive director of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

Prof. Capron, who earned his LL.B. at Yale University and B.A. (High Honours) from Swarthmore College, specialises in health policy and medical ethics. He has written or edited eight books, including Law, Science and Medicine and the Treatise on Health Care Law. His recent articles and chapters cover such issues as brain-based determinations of death, current controversies in human gene therapy, genome mapping, human cloning, and research with human beings.

Doctor of Medicine, Master of Public Health, Doctor of Philosophy
Hospital Physician, Lyon tertiary teaching hospitals – Assistant Professor, Claude Bernard University Lyon, F
Training in Clinical Medicine, Public Health, Clinical Epidemiology, and Health Economics
Fellow, University of Pennsylvania, School of Medicine and Wharton School, Philadelphia, USA

Research
Chair (1995- ), Clinical Epidemiology Unit, Hospices Civils de Lyon, France
Member (1990- ), CNRS research unit UMR 5823 "Méthodes d’Analyse des Systèmes de Santé"
Member (2001- ), Experts group, Cell therapy, French regulatory agency for health products AFSSaPS

Ethics
Former President (1998-2004) and Vice-Président for Europe (2004- ),
French National Confederation of Research Ethics Committees (REC = French CCPPRB)
Former President (1998-2004) and Vice-Président (2004- ),
Lyon Research Ethics Committees (CCPPRB of Lyon B)
Member, Institutional Ethics Committee (1998- ), Lyon tertiary teaching hospitals and University

International Boards
Member, Executive Board (1995- ), RECIF (Réseau d’Epidémiologie Clinique International Francophone)
Member, Board of Trustees (2000- ), INCLEN Trust (International Clinical Epidemiology Network)

Teaching
Co-founder and co-Chair (1999- ), University Diploma in Ethics, Claude Bernard University Lyon
Co-founder and co-Chair (1997- ), University Degree in Research Methodology, C Bernard University Lyon
Co-founder and Chair (2004- ), Master of Sciences, Clinical Research, Claude Bernard University Lyon

Other Societies
Member (1992- ), CUESP Collège Universitaire des Enseignants de Santé Publique, France
Member (1990- ), SMDM Society for Medical Decision Making, USA
Corresponding member for France (1993- ), ISPE International Society for Pharmaco-Epidemiology, USA

An MD and Professor of Nuclear Medicine at the University of Bonn, Elmar Doppelfeld joined a group of German academics in 1980. They started a forum for exchange of information and harmonisation for the work of ethics committees, as established by the Faculties of Medicine and the Medical Associations in the German States since the late seventies. Prof. Doppelfeld became secretary general and chairman of this permanent working group of ethics committees in 1994. Up to now, there is no national ethics committee for medical research in Germany, so this group (Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland) has been accepted as an important consultancy for the public, governments and parliaments.

In 1992, Prof. Doppelfeld – scientific editor of the Deutsches Ärzteblatt (1988-2004) – was appointed by the German Government as a member of the German delegation to the Council of Europe’s Steering Committee on Bioethics (CDBI). He was a member of the Working Party which prepared the additional protocol on biomedical research adopted by the Committee of Ministers on 30 June 2004. He was elected as vice chair of the CDBI in 2003 and is chairman of a Working Party developing an instrument on research using biomaterials of human origin.

Born in 1935 Appelscha, the Netherlands, Pieter Drenth studied psychology at the Vrije Universiteit in Amsterdam and the New York University in New York (PhD 1960). He has been professor of psychology since 1967 at the Vrije Universiteit in Amsterdam, and visiting professor at Washington University, St Louis, USA (1966) and University of Washington, Seattle, USA (1977).

Between 1982-1987 he served as Rector Magnificus at the Vrije Universiteit. From 1990-1996 he was president of the Royal Netherlands Academy of Arts and Sciences, and since 2000 he has been president of ALLEA (All European Academies, i.e. the European Federation of national Academies of Sciences and Humanities).

University courses and degrees:
1982-1990 Catholique theology at the University of Bonn and at the Institut Catholique de Toulouse
1983-1988 German philology and philosophy at the University of Bonn, at the Université Toulouse-LeMirail, and the University of Cologne
1988 First State Examination, University of Bonn
1990 Diploma-exam, examined by the Catholic Theological Faculty, University of Bonn
1997 PhD, Department of Philosophy, University of Bonn

Academic Jobs:
1989-1990 Assistant to the Chair of Prof. Dr. L. Honnefelder
1991-1994 Academic Assistant at the German Bundestag
1992 Assistant at the Dept. of Philosophy, University of Bonn
Since 1994 Managing Director of the Institute for Science and Ethics (IWE), Bonn

Memberships:
Since 2000 Representative of the IWE at the Board of Directors of the European Association of Centres of Medical Ethics
Partner and project leader in several European and national research projects on bioethics and research ethics.

Sara Gambrill is senior editor at Thomson CenterWatch, a publishing company that focuses on the global clinical trials industry. Ms Gambrill has written many feature-length articles for both The CenterWatch Monthly and CWWeekly on various aspects of the clinical trial industry. She is editor of the feature “CentreStage Europe” for Thomson’s CenterWatch Monthly publication, for which she has written and edited numerous articles on the impact of Directive 2001/20/EC, as well as other areas of interest to the clinical trials industry in Europe. In addition, she is the chief editor of ten book titles published by Thomson CenterWatch, including Protecting Study Volunteers in Research, Informed Consent, The CRA’s Guide to Monitoring Clinical Research.

Assoc. Prof. Jozef Glasa, MD, PhD (medicine), physician and clinical researcher, teaches clinical pharmacology, hepatology and medical ethics (bioethics) at the Slovak Medical University in Bratislava. Founding editor of the journal Medical Ethics & Bioethics, co-editor of textbooks on medical ethics and nursing ethics, and of several international volumes on medical ethics/bioethics, and on hepato-pharmacology. Scientific Secretary of the Slovak Society of Hepatology (1992-), and Society of Clinical Pharmacology (1996-2002). Member of EASL and IASL (Eur./Int. Assoc. for the Study of the Liver) and of EACPT (Eur. Soc. for Clin. Pharmacol. and Therap.).

Secretary (1990-2) then present chairman (2002-) of the Central Ethics Committee, Ministry of Health of the Slovak Republic (SR). Deputy director of the Institute of Medical Ethics and Bioethics (IMEB) in Bratislava (1992-1993), director of IMEB Fdn./n.f. (1993-). Slovakian Republic delegate to the Steering Committee on Bioethics (CDBI; Council of Europe (Strasbourg)), member of the CDBI Bureau (2004-). Member of the Board of COMETH (2001-).

Göran Hermerén has been a professor of medical ethics at the Faculty of Medicine, Lund University, Sweden, since 1991, professor of philosophy, Lund University, since 1975, and professor of philosophy and theory of science at Umeå University, from 1970. He is the coordinator of the EU-funded research project ‘Euro-priorities’, and a partner in several ongoing EU-funded research projects.

Professor Hermerén has published books and papers on ethical problems in international periodicals. His current research interests include ethical aspects of gene testing, priority- setting, and stem cell research. He has been a member of the National Council on Medical Ethics in Sweden since it began, and has served on governmental commissions and as a referee for international journals. He is currently chairman of the ethics committee of the Swedish Research Council (Stockholm), chairman of the advisory board of the German reference centre for ethics in the life sciences DRZE (Bonn), and president of the European Group on Ethics in Science and New Technologies (Brussels).

Born in Nancy on 24 May 1930
Married with three children
Chevalier of the Ministry of Education
Officer of the Legion of Honour

Political Functions
Senator of Meurthe et Moselle (1983-2001)
Honorary Senator-Honorary MP
Former President of the Mayors’ association of Meurthe et Moselle
Former President of the General Council (1982-88)

Other functions and assignments
President of the Council for the Supervision of the National Treasury for family allowance (1997-2001)
President of the Hospitals Union of the North East of France
Former member of the National Advisory Board on Ethics for Life Sciences and Health (1995-2001)
Former member of the High Committee of Public Health
President of the National Office for the compensation of medical accidents, iatrogenic affections and bacterial infections
Member of the UNESCO International Bioethics Committee
President of the Curie Institute
State advisor in extraordinary duties
Vice President of the French Hospitals Federation

Profession
Physician
Former head of the Nephrology Department of the Nancy CHU
Emeritus professor within the Medicine Faculty of Nancy University

Alar Irs joined the Estonian State Agency in 1997 as a medical officer responsible for the protocol evaluation of clinical trials and was later involved in GCP compliance evaluation and GCP inspection. From 2000 to 2003 he was the head of the department of registration, responsible for the coordination of drug registration, clinical trials, drug information, advertising control, pharmacovigilance and drug statistics in Estonia. Since August 2003 he has held his current position as the deputy director of the State Agency of Medicines.

Alar Irs graduated as a physician from the University of Tartu, Estonia and has a postgraduate training in clinical pharmacology. He has experience in European regulatory affairs from his secondment to the EMEA in 2000. He was the CADREAC observer to the EMEA ad hoc GCP meetings for two years, and is a member of the Pan-European Regulatory Forum for Pharmaceuticals (PERF) acquis group. He is Estonia’s alternate member of the CHMP, a member of the Efficacy Working Party, and a lecturer in clinical pharmacology at the Division of Clinical Pharmacology at Tartu University.

In 1972, Ms Jensma graduated in Dutch law at the University of Groningen, before specialising in medical law and teaching it. In 1986, she set up a Medical Ethics Review Committee at the Deventer Hospital and remained a member of this committee until 2001.

Ms Jensma is currently a member of several Research Ethics Committees, is the Secretary of the Netherlands Association of Medical Ethics Committees (NVMETC), is involved in intercollegiate audits for RECs (set up by the NVMETC), is a member of the Steering Committee for and teacher on the national training of REC members, and a member of the guidance committee for the evaluation of the Dutch Medical Research Involving Human subjects Act (WMO). She is also an editorial board member of the Ethics and Law in Healthcare periodical.

Educated in Britain, Toby Johnson has worked as a journalist and consultant at European level since 1987. He is active in the fields of employment, the social economy, local development, enterprise, innovation and research and for five years has edited Euroabstracts, the European Commission’s bimonthly review of publications in enterprise, innovation and research.

Finn Kamper-Jørgensen MD PhD, comes from Denmark. Since 1981, he has been Director at the National Institute of Public health, and since 2002, Chairman of the Danish National Committee for Biomedical Research Ethics. Other posts include: 1983-1991 EU Specialised Working Group on Health Services Research (vice-chairman 1988-1991), and chairman of the EU’s Science and Society programme, Ethical Cluster, between 2003-2004.

He has extensive scientific publishing and experience in the international evaluation of research, research programmes, research institutes and medical education.

Ingrid Klingmann studied medicine in Germany and specialised in general medicine, clinical pharmacology and pharmaceutical medicine. Having joined the pharmaceutical industry as medical advisor, she has held senior management positions in different international contract research organizations. Since January 2003, she has run her own pharmaceutical development consulting company. In January 2004, Dr Klingmann became CEO of UCL Analgesia Centre Ltd. in London, UK.

Dr Klingmann is a founding member, member of the board and former chair person of the Ethics Working Party of the European Forum for Good Clinical Practice (EFGCP). She is a founding member and member of the Board of the Association for Applied Human Pharmacology (AGAH) in Germany, a member of the Steering Committee Europe (SCE), and former chair person of the SCE of the Drug Information Association (DIA).

Bartha Maria Knoppers, Canada Research Chair in Law and Medicine, is professor at the Faculté de droit, Université de Montréal, senior researcher at the Centre for Public Law (C.R.D.P.), and Officer of the Order of Canada and Fellow of the AAAS. She has been Chair of the International Ethics Committee of the Human Genome Organisation (HUGO) since 1996, a member of the Board of Genome Canada, and is co-founder of the International Institute of Research in Ethics and Biomedicine (IIREB). In 2003, she became Director of the international Public Population Project in Genomics (P³G).

1978-1984
Study of human medicine at the Free University Berlin
1985
Medicinal expert - Landesamt für Zentrale Soziale Aufgaben
1986
Kinderklinik Norderney
1987
Federal Institute for Drug and Medical Devices in the Pharmacology and Toxicology Division
1988
Head of Scientific Pre-evaluation Unit in the Pharmacology and Toxicology Division
1996
Head of Decentralised Procedure Unit in the EU-Procedures Division
2000
Deputy Head of EU Division
2002
Pharmaceuticals Unit, DG Enterprise, European Commission
Member of the Mutual Recognition Facilitation Group
Member of the European Commission ad hoc groups

• on Mutual Recognition and
• Labelling (Patient Package Insert)
• Expert: Notice to Applicants
• CPMP Expert

Past chairperson of the Mutual Recognition Facilitation Group (German Presidency)

Lecturer at the University Bonn on Drug Regulatory Affairs
Lecturer at the University Witten/Herdecke on Regulatory Affairs

Born in 1965 in Olsberg, Germany, Dr Liese studied his medical thesis at the Institute for Human Genetics in the University of Bonn. Following a six-month stay in Central America, where he worked in a state-owned hospital and on foreign aid projects, he became a ward doctor in the children’s hospital in Paderborn, Germany. Since 1994 he has worked in a joint medical practice.

Dr Liese became an MEP in 1994, representing the Group of the European People's Party (Christian Democrats) and European Democrats (EPP/ED). He is also Chairman of the EPP/ED - Working Group on Bioethics in the European Parliament, and in 2001 became EPP/ED-Coordinator on the Temporary Committee on Human Genetics and other new technologies of modern medicine. Other commitments include membership of the Committee on the Environment, Public Health and Food Safety, and substitute member on the Committee on Industry, Research and Energy.

As Deputy Director of the Office for Human Research Protections - OHRP (formerly the Office for Protection from Research Risks - OPRR), Dr Lin is responsible for the management of OHRP policy, personnel, and budgetary matters regarding biomedical and behavioral research at both national and international level. She also serves as Director at the Office of International Activities at OHRP.

Melody Lin, a native of Taiwan, received a B.Sc. degree in pharmacy, and is a registered pharmacist. She received her PhD in microbiology/immunology and carried out research at the George Washington University Medical Center and the National Cancer Institute, National Institutes of Health (NIH). Dr Lin is a Captain in the US PHS Commissioned Corps. Previous OHRP/OPRR duties include AIDS Coordinator, Chief of the Compliance Oversight Branch, and Director of Division of Human Subject Protections. She is a member of the Advisory Committee of the National Research Programme in Genomic Medicine in Taiwan, is US liaison to the National Council on Ethics in Human Research in Canada, and is a member of the Advisory Council in European Forum on Good Clinical Practice.

Pia Locatelli

Born in Bergamo, Italy, Ms Locatelli holds degrees in foreign languages and literature and in economics. Following years in education as a teacher, she later became an entrepreneur in the textiles industry (until 2000).

Ms Locatelli has been a member of the Board of Directors of the University of Bergamo, 1992-1997; vice-president of Socialist International Women, 1992-1999; member of the Italian National Commission for Equal Opportunities, in charge of international relations, 1997-2003; member of the national executive of the Socialisti Democratici Italiani party, in charge of international relations; member of the Bureau of the Women’s Standing Committee of the European Socialists party; president of the “Fondazione A.J. Zaninoni” which has among its aims the study of economic trends, analyses of labour market mechanisms, and the promotion of equal opportunities; and president of Socialist International Women, elected in October 2003. She is also a Member of the European Parliament (2004-2009).

Ruud ter Meulen, born in 1952, is a psychologist and ethicist. He is Director of the Institute for Bioethics and Professor for Philosophy and Ethics at the University of Maastricht in the Netherlands. His main research areas are research ethics, resource allocation (particularly as regards elderly care), medical ethics committees, ethical pluralism and the problem of consensus.

Prof. Ter Meulen has directed several European projects, including the two-year EVIBASE (Ethical Issues of Evidence Based Practice in Medicine and Health Care) which finished in 2003. He is coordinator of NOMET, the national training course for members of research ethics committees on the ethical and legal issues of medical research with human beings. This project is sponsored by the Ministry of Health and promoted by the Central Committee for Medical Research with Human Persons (CCMO).

Qualifications
- Semmelweis Medical University, Budapest, MD (1992)
- Haynal Imre University of Health Sciences, rheumatologist (1998)
- Pázmány Péter Catholic University, Budapest, Department of Law and Political Sciences, graduate in law (2000)

Practice in bioethics and medical law
- Lecturer in bioethics at Pázmány Péter Catholic University, Department of Law and Political Sciences, Institute of Civil Law, Sub-Department of Bioethics (1997-2000)
- Lecturer in medical law at Pázmány Péter Catholic University, Department of Law and Political Sciences, Institute of Civil Law (2000-2004)
- Deputy head of Department of Secretariat Medical Research Council and Ethics Committee of Human Reproduction (2002-present day)

Marie Moores joined the pharmaceutical industry in 1995 having worked as a nurse for five years in the intensive care environment. Since that time she has worked as a clinical research associate, project manager and is currently Director of Clinical and Regulatory Operations at Theradex (Europe) Ltd. In all, she has over nine year's experience in managing clinical oncology trials. This includes the preparation and submission of regulatory dossiers to agencies in the EU and Australia as well as providing support to site staff in making clinical trial submissions. Mrs Moores is also the person responsible for the pharmacovigilance of Theradex in Europe.

In addition to her nursing qualification, Mrs Moores gained an M.Sc. in clinical research from the Welsh School of Pharmacy in 1999, and is currently taking a Bachelor of Law at the London College of Law. She is also an expert evaluator for the European Commission on research funding for various programmes within the bioethics area.

Hanna Nohynek completed her medical studies in Helsinki, Finland, and is presently working at the Department of Vaccines for the National Public Health Institute as a senior scientist. She is the scientific project coordinator of the ARIVAC trial, a phase III effectiveness study of an 11-valent pneumococcal conjugate vaccine against childhood pneumonia being conducted by the international ARIVAC consortium on the island of Bohol in the Philippines. She did her PhD on the serodiagnosis of childhood pneumonia which she has studied in Finland, Russia, and the Philippines.

She has coordinated six phase II trials on a number of vaccines, and her current research interests are in measurement of acute respiratory infection disease burden, pneumococcal and meningococcal vaccines, herd immunity, decision-making and evidence-based implementation of new vaccines into national programmes, cost evaluation of vaccines as well as bioethics related to clinical trials.

Peter O'Donnell has a wealth of experience writing about European affairs for media across Europe and the United States, covering everything from enlargement to maritime safety, and from financial services to the Southern Caucasus. He has worked in Brussels for more than 15 years, and is currently editor of Europe Information Service, the Brussels-based news agency. He is well-known in the pharmaceutical and health fields having written a regular column, for over ten years, on European affairs in Applied Clinical Trials. He has also reported on health matters for the Financial Times, Reuters, and BioWorld International.

Renzo Pegoraro was born in Padua, Italy, on 4 June 1959. He graduated as doctor of medicine at the University of Padua (1985), then studied philosophy and theology in Padua and in Rome, graduating with a degree in moral theology (1990). He graduated with a diploma in ACorso di perfezionamento in Bioetica@ at the Catholic University in Rome. In 1993, he was the visiting researcher at the Kennedy Institute, Washington DC. In 1993, he became Professor of Bioethics at the Faculty of Theology of Northern Italy in Padua, and General Secretary of the AFondazione Lanza@ (a centre of advanced studies in ethics, bioethics and environmental ethics). Since 2001, he has been President of the Fondazione Lanza.

He is Professor of Bioethics at the School for Obstetricians of the Faculty of Medicine, University of Padua. In 1994, he was appointed as President of the Ethics Committee of the Regional Centre of Oncology and, since 1998, has been President of the Research Ethics Committee of the Medical Centre of Padua. Between 2000-2002, he was a member of the National Healthcare Council, and serves as an ethicist in several institutions. He is President Elect of the Executive Committee of the European Society for Philosophy of Medicine and Health Care, and a member of the Bureau of the European Association of Centres of Medical Ethics. Renzo Pegoraro has published articles in journals and books on different issues in biomedical ethics, in particular, religion and bioethics, human experimentation, organ transplantation, and elderly care.

Octavi Quintana Trias is an MD MPH specialist in critical care. He has worked as attending physician in an intensive care hospital unit for eight years. He served as director of the Regional Hospital of Malaga in Spain and later worked as senior advisor at the Spanish Ministry of Health. He is a former director of international affairs at the Ministry of Health and Consumer Affairs in Spain, and a former president of the Spanish Society on Quality Assurance, the Steering Committee on bioethics at the Council of Europe, and former vice-president of the European Group of Ethics at the European Commission.

Mr Octavi Quintana has acted as a health coordinator in humanitarian crises, and since 2002 has held the post of Director for Health Research at the European Commission’s Directorate-General for Research and Technology Development.

Povl Riis received an MD from the University of Copenhagen in 1952, and a DM Sci in 1959. He was professor of medicine at the University of Copenhagen between 1974-96; vice president of the European Science Foundation between 1974-77; and Chairman of the Danish Medical Research Council, 1972-77.

He has held several other posts including Chairman of the Central Research Ethics Committee of Denmark (1979-98); Member of the Danish Board Against Scientific Dishonesty (1992-99); and Scientific Editor-in-Chief of J. Dan. Med. Ass. (1967-91). He is currently an editorial board member on a number of international journals including JAMA; Advisory contributions in research ethics to EU and the Council of. Europe; DM h.c. (Odense & Gothenburg); honorary member of FRCP (London), and medical associations in Iceland, Sweden and Finland; and Chairman of AgeForum since 1996.

Elisabeth Rynning LL.D., is a Professor of Medical Law at the Department of Law, Uppsala University. Her research has primarily been focused on various issues related to patients’ rights and biomedical research, including international and comparative aspects. She has taken part in European research projects such as EURICON (on consent issues in neonatal research) and PRIVIREAL (on the processing of personal data in medical research).

Elisabeth Rynning is a member of the Swedish National Council for Medical Ethics and, for several years, was the legal expert of the Swedish Medical Research Council’s Board for Research Ethics. She has participated in a number Swedish law commissions in the areas of health care and research. Publications include Samtycke till medicinsk vård och behandling. En rättsvetenskaplig studie (Consent to medical care and treatment: A legal study), Offentligrättslig reglering av biobankerna – en utmaning för lagstiftaren (Regulating the biobanks – a challenge to legislators), and Processing of Personal Data in Swedish Health Care and Research; implementation of the Data Protection Directive in Relation to Medical Research in Europe.

Judit Sándor received her Doctor of Law at the Faculty of Law in Budapest. In 1990, she was a visiting scholar at the McGill University in Montreal, specialising in medical law. She completed the Hungarian bar exam and in 1991 was an intern in London with Simmons & Simmons. Prof. Sándor received an LLM degree on comparative constitutional law (New York Board of Education and CEU) before becoming a visiting scholar at the Hastings Center (New York) in 1993, and receiving a Mellon fellowship at the Maison des sciences de l'homme (Paris, 1996). In the same year she was awarded a PhD in law and political science, before being made associate professor of political science and law in 2000.

Her main publications and books are in the fields of health care law, human rights, reproduction and genetics. In 2004, Prof. Sándor was given the title of professor of law and political science at the Central European University, Budapest. She has participated in several European Commission research projects, and in 2004 started work as the Chief of the Bioethics Section at UNESCO, in the Division of Ethics of Science and Technology at the Social and Human Sciences Sector in Paris.

Born 1928, Daniel Serrão has a PhD in medicine, is a Professor of Bioethics and Medical Ethics, and holds a Masters, at the Faculty of Medicine of Porto (Portugal). Member of the Academy of Sciences and of the Portuguese Academy of Medicine; Director of the Centre for Bioethics Studies; Portuguese representative on the Council of Europe’s Bioethics Task Force (CDBI); Coordinator of the Research and Health Care Commission at the Health Ministry. Member of the Scientific Council of the Medical Genetic Institute; founder member of the International Association of Bioethics; Member of the International Committee of Bioethics (UNESCO; 1994-1998) and of the Pontificia Accademia per la Vita (Holy See); Member of Portuguese Council on Ethics of Life Sciences.

Daniel Serrão is also Author of 248 articles and four book chapters.

Jiri Simek is head of the Institute for Medical Ethics and Nursing at the Third Faculty of Medicine, Charles University in Prague. He is responsible for teaching humanities at the Faculty of Medicine and takes an active part in organisation of university studies for nurses. He is chairman of the Local Ethics Committee and was a member of the Ministry of Health’s ethics committee for several years. He is involved in the education of ethics committee members in the Czech Republic. His background is in internal medicine, psychiatry and psychosomatics.

During the last 14 years, Jiri Simek has also been active in research in the field of medical ethics (patients’ rights, ethical aspects of transformation of health care systems, patients in advanced technology medicine, quality of life of dementia patients, informed consent in the Czech Republic, etc.).

Sigrid Skavlid, born 1966, cand. mag. in Political Science from the University of Oslo. She has been working for the committees for research ethics in Norway in the central secretariat since 1997. Besides being the editor for the committees web pages, and journalist in the committees quarterly magazine Forskningsetikk, she is project leader for the new electronically application system the regional committees released January 2005.

Carlos de Sola was born in Spain in 1949. He is a lawyer and graduate of the University of Salamanca and University of the Sorbonne. Administrator at the Council of Europe since 1978, and Head of Bioethics Department since 1991.

Participated, as Secretary of the Steering Committee on Bioethics, in the preparation of the Convention on Human Rights and Biomedicine (Oviedo, 1997) and its three additional Protocols on the Prohibition of Cloning Human Beings (Paris, 1998), on Transplantation of Organs and Tissues of Human Origin (Strasbourg, 2002) and on Biomedical Research (Strasbourg, 2005). Author of several articles on bioethics as well as environmental law. Participated, either in a personal capacity or as a representative of the Council of Europe, in numerous international bioethics meetings.

Dr. iur, Associate Professor at the Law Faculties of the Universities of Fribourg and Neuchâtel, and Founder and Deputy Director of the Institute of Health Law of the University of Neuchâtel. Dominique Sprumont has a very wide experience in the legislation of research involving human beings. He contributed to the drafting of the first national regulation of drug trials in 1993 (IOCM Clinical Trial of Medicinal Product Regulation), as well as to the norms of application at cantonal level. He is currently a legal expert of the Swiss Federal Office of Public Health as regards the Draft Proposal of the Federal Act on Research involving Human Beings.

He was invited by the Swiss Federal Office of Justice to be an observer for the Draft Additional Protocol on Biomedical Research adopted by the CDBI in June 2003. Since 1994, he has been involved in the organisation and conduct of training programmes for ethics committee members in Switzerland. He has also acted as an expert in the Council of Europe’s DEBRA (Ethical Review of Biomedical Research Activity) project in Bulgaria, Slovenia, Estonia and Lithuania.

Zoran Stančič

Dr Zoran Stančič was born in 1962 in Kranj, Slovenia. Having finished his BSc in geodetic engineering at the University of Ljubljana in 1986 he worked as a research assistant at the Department of Archaeology at the University of Ljubljana. In 1990 and 1991-1992 he was a research fellow at the University of Arkansas, USA and in the Faculty of Geodetic Engineering, Delft University of Technology, NL. In 1992 he completed his PhD with a dissertation on the application of information systems and digital image processing of remotely-sensed images in archaeology. Having held a variety of university research posts between 1992-1997, Dr Stančič took up the post of visiting professor at the Department of Art and Archaeology, Universite de Paris I, Sorbonne, and Associate Professor at the Department of Geodesy, University of Ljubljana, SI (1997-2000). Between 1999 and 2000 he was employed as deputy-director of the Scientific Research Centre at the Slovenian Academy of Sciences and Arts.

He has published seven scientific books in Slovenia and abroad, plus a number of scientific papers on quantitative methods in archaeology and remote-sensing. Dr Stančič is also a member of the editorial board of the International Journal of Geographic Information Sciences (Leicester, UK) and of the Steering Committee of the Computer Applications and Quantitative Methods in Archaeology. Between 2000-2004 he was State Secretary for Science at the Ministry of Education, Science and Sport in the Republic of Slovenia, with responsibilities for policy-making, fund distribution and international scientific cooperation. Since December 2004 he has been working with the European Commission where he is currently Deputy Director-General.

Fergus Sweeney has a first degree in physiology (1979), a doctorat de troisiéme cycle in cancer biology (1982), and a PhD in pharmacology (1986).

In 1999, he joined the EMEA (European Agency for the Evaluation of Medicinal Products)
Inspections Sector with responsibility for the coordination of GCP inspections and, more recently, pharmacovigilance inspections. He has also been closely involved with the development of the EudraCT database – the community database of clinical trials. Prior to that he worked in the CRO industry from 1982 to 1999, covering phase I-IV clinical research and laboratory activities, primarily in the field of quality assurance.

He has extensive experience as a QA manager and auditor in Europe, the United States, Asia, Australia and South Africa. This covers a wide range of therapeutic areas, including: cardiovascular, psychiatry, transplant, oncology, infectious diseases, pulmonary function and allergy.

Zbigniew Szawarski, philosopher, with particular interests in moral philosophy, philosophy of medicine and medical ethics. Graduated from Warsaw University in 1963. Took year-long scholarship at Oxford University in 1975-6. Member of the ESPMH from 1989. One of the first philosophers in Central and Eastern Europe interested in philosophy of medicine and medical ethics.

Former editor of ETYKA. Member of editorial boards of several international journals devoted to medical ethics. Participant in four BIOMED projects. Between 1990-99, lecturer at the Centre for Philosophy and Health Care at the University of Wales in Swansea. Has written three books and numerous articles on medical ethics. Became Professor of Moral Philosophy at the Institute of Philosophy, Warsaw University in 1999.

Professor Daniel Tarschys is Chairman of the Swedish National Council for Medical Ethics. He also chairs the Department of Political Science at the University of Stockholm, and several governing boards in fields such as growth policy, ageing, and international exchange and mobility. A former Secretary-General of the Council of Europe (1994-99), he has been Secretary of State in the Swedish Prime Minister’s Office and a member of the 2000 Convention drafting the EU Charter on Fundamental Rights. As a member of the Swedish Parliament for 15 years, he chaired the Standing Committees on Social Affairs and Foreign Affairs. His publications cover comparative government, public administration, budget policy and political philosophy.

Caroline Trouet (1972) received her PhD in law (University of Leuven) with a thesis concerning the legal regulation of the secondary use of human biological materials. She is deputy general manager of pharma.be, the Belgian Association of the pharmaceutical industry, and a voluntary staff member at the Centre for Biomedical Ethics and Law, University of Leuven.

Her research activities cover health law and pharmaceutical law in general, paying special attention to the regulation of biomedical research and biobanking. She is a former member of the research ethics committee of the Faculty of Medicine, Katholieke Universiteit Leuven.

She is the author of several publications in these fields, including “Clinical trials in Belgium: Operational guidance” which will be published by Intersentia in December 2004.

Jože Trontelj

Jože Trontelj, born on 1 June 1939 in Slovenia. Medical doctor and doctor of neurosciences. Professor of neurology at the Ljubljana Medical School. Author or co-author of over 150 papers in journals, over 30 book chapters, and two books, mainly on electromyography and physiological basis of neurological disorders. Responsible for over 70 publications on bioethical issues.

‘Boris Kidric Prize for outstanding research achievements’, 1989. Since 1991, member of the Slovenian Academy of Sciences and Arts, since 2002 its Vice-President. Since 1995, Chairman of the National Medical Ethics Committee of Slovenia and Slovenian delegate to the Council of Europe’s Steering Committee on Bioethics (CDBI). Member of the CDBI Working Party which drafted the Additional Protocol to the Convention on human rights and biomedicine, on biomedical research.

Jiří Vortel, MD, was born in 1949 in Hradec Kralove, Czech Republic. In 1973, he graduated from the Faculty of Medicine at Charles University and worked in the department of internal medicine at the district hospital in Nachod. Having been awarded a specialisation in internal medicine in 1976 and again in 1980, Dr Vortel held various posts including head of the intensive care unit, a member of the Cardiology Group at the University Hospital in Hradec Kralove, and a specialist in clinical pharmacology.
Since 1999 he has been chairman of the University Hospital in Hradec Kralove; member of the National EC in the Czech Republic (2001-2004); member of the EC’s working group organised by the State Institute of Drug Control (from 2004); and a member of the Czech Republic’s EC Forum since 2004.

Janet Wisely

Originally, Janet Wisely studied physics before obtaining a PhD in low- temperature physics from the University of London. She joined the UK’s National Health Service at the then North East Thames Regional Health Authority in 1992 as an R&D national programme manager. In that role Dr Wisely was responsible for commissioning and managing three national R&D programmes covering the interface between primary and secondary care, implementation of research findings, and mother and child health.

In April 2002, she joined the Central Office for Research Ethics Committees (COREC). Originally a project manager, Dr Wisely was subsequently appointed as director of corporate affairs, where her responsibilities included the operation of the NHS REC system.