Dr. Beat Widler, a Ph.D. graduate from the Swiss Federal Institute of Technology in Zurich, and holds the Swiss Diploma of Pharmaceutical Medicine.
He operates as an independent CQA, Quality Risk Management, GCP & Pharmacovigilance Auditing
Expert and is Managing Partner at Widler & Schiemann AG (www.wsqms.com) in Zug Switzerland.
Over his 30 years long career in the pharma industry he built his extensive knowledge in the field of
clinical development. From 1986 till 2012 Dr. Widler worked for Hoffmann-La Roche first as an
International Drug Regulatory Affairs officer, then as a Senior Clinical Research Scientist.
In 1993 he then joined the International Clinical Quality Assurance department. From 1997 to 2011 he was the Global Head of the Department for Quality, Ethics and Systems’ in Roche Pharma. In 2012 he
founded together with Dr. Peter Schiemann Widler & Schiemann Ltd.
Dr. Widler is an active member in a variety of international GCP working parties and he regularly
lectures at DIA, EFGCP, WHO, ECPM (University Basel) seminars. In the areas of quality risk
management and Quality by Design he was an active member of the CTTI (Clinical Trials
Transformation Initiative) and OECD working groups.
He is a founding member of ACRES – the Alliance for Clinical Research Excellence and Safety (www.acresglobal.net), founding member of the midata cooperative (http://www.datenundgesundheit.ch) and a member of the SAFE-Biopharma Advisory Board.
He was the project leader for the development of the Association of the British Pharmaceutical
Industry (ABPI) Clinical Trial Disclosure Toolkit, released in August 2013.
Mary Lynne Van Poelgeest-Pomfret is a long-standing dedicated international patient advocate promoting the rights of patients at both national and international levels. At the forefront of health-related concerns in the Netherlands and internationally. A member of several patient advocacy movements and organizations like IAPO (International Alliance of Patient Organizations) and EPF (European Patients Forum). She has organized several workshops and given numerous presentations at major international scientific and patient advocacy organizations. A member of the Steering Group MedTech – Patient Dialogue as an EPF representative. She also sits on a number of EPF working groups and steering committees, culminating in the Universal Access to Healthcare campaign in December 2017. She became a Board member of EFGCP in April 2016 and sits on a number of EFGCP working groups. She became Vice-Chair of EFGCP as of March 2017 and is keen to actively contribute to the work of EFGCP, primarily from the patient perspective. She participated in the first EUPATI workshop of patient advocate experts in Frankfurt in September 2012 and actively participates in ËUPATI. Lynne became the President of WFIP – World Federation for Incontinent Patients in January 2011: an international umbrella organization dedicated to enhancing the rights of patients suffering from incontinence and pelvic floor dysfunction in general. In this capacity the latest initiatives include a collaborative agreement with the European Association of Urology relating to patient advocacy issues and a Patient Platform. Also until April 2016, chairperson of the ICP – Netherlands Interstitial Cystitis Patients’ Organization Most recently January 2017 she became a member of the ‘Core Board’ for one of the EIP –AHA Focus groups led by the University of Valencia, Spain.
Lynne worked for Shell in the Netherlands for 23 years and has a BA degree from the UK and Drs. Degree from Leiden University in the Netherlands.
Rieke van der Graaf studied classics (MA, 2001) and theology (MA, 2006) at Leiden University. She has written a PhD thesis on ‘Ethical fundamentals in human subjects research. On equipoise and human dignity’ (2010). In this thesis she has applied equipoise and human dignity to concrete controversial issues in research ethics, like standard of care and biobank research. Her current research interests are global justice in international research, the integration of care and research, fair subject selection and the ethics of innovative research designs. She is a member of the Research Ethics Committee of the UMC Utrecht and she has been the Secretary of the Working Group on the Revision of the CIOMS Guidelines (2016).
Susan Trainor has worked and lived for over 30 years in a global environment. She has extensive international experience, including more than 25 years in bio-pharmaceutical development. She is a trained ISO-9000 Lead Auditor and a Certified Empowerment and Self Leadership coach.
She is consulted by the International Health Care Industry in the area of quality management, risk assessments, due diligence and leadership coaching, internationally.
She is the founder, President and CEO of Trainor & Partners, a firm specializing in quality management of clinical research for developed and emerging regions and she is the co-founder and Director of Sutra Quality Management. The firms operate out of Belgium & India, with consultants situated internationally.
More recently she founded SuTra Coaching a division of Trainor & Partners specialized in Organizational Culture and Empowerment and Self Leadership coaching.
Paul Strickland founded Strickland Quality Assurance Ltd, a QA consultancy capitalising on his 25 years of experience in Clinical Quality Assurance. As a consultant he has audited across the world, for organisations of all sizes. He has also given GCP training and refresher courses, inspection preparation guidance and support during the inspections themselves.
Paul previously worked for twelve years at Amgen Ltd, most recently as Director of Intelligence and Inspections, and Regional Head of Clinical Auditing. In former years, Paul worked in a GCP auditing capacity with the Wellcome Foundation and with Glaxo. From the beginning, he led the facilitation of many regulatory inspections, both in-house and in the field in Europe, USA and Africa. He also has several years’ previous experience in QA of manufacturing with Serono Diagnostics. His first healthcare role was in 1979 with Amersham International.
Paul has been course principal for the RQA GCP auditing course for seventeen years, and was a tutor on the course for a number of years before this. He gained RQA’s Diploma in Research Quality Assurance in 1998 and is a Fellow of the Association. Paul is the chair of the Audit Working Party, a subgroup of the EFGCP, and has held this role since 2005. He is a member of the EFGCP Board and an invited member of the MHRA Stakeholder Engagement Meeting.
Heather A. Sampson, Assistant Professor, Department of Family & Community Medicine, University of Toronto, Department of Research, Michael Garron Hospital, Chair of Toronto Public Health Research Ethics Board
Responsible for facilitating an integrated program of community-based health research, including clinical trials, health outcomes measurement and knowledge translation at the Michael Garron Hospital and teaching at the University of Toronto, Faculty of Medicine. She also provides education and support for Research Ethics Board (REB) members, researchers, medical residents, medical students, support staff, patients and families.
Invited to join Research Ethics Boards presented an enigma that developed into more than a passing interest. She finds that having held a number of medical and health research grants in the area of research and research ethics has contributed to informing her on the challenges of being a researcher, clinical research facilitator and REB member. As a member of a number of international research groups she contributes to global harmonization research efforts; working towards breaking existing barriers to conducting “medical research without borders”.
Believes that all medical and healthcare innovation and/or research that is worth doing, is worth doing well. For example, she is currently Principal Investigator on an education research grant with the University of Toronto and the Royal College of Surgeons of Ireland: Transatlantic medical student integration: an innovative research education program.
Also believes that doing clinical research is fun and rewarding; witnessing participant driven healthcare change and improvement due to innovation and research is an honour and a privilege.
When not running the clinical research program at the Michael Garron Hospital, Toronto East Health Network, teaching research methodology to 2nd year medical students at the University Of Toronto Faculty Of Medicine, being an international research ethics advisor or REB chair and member, is found sailing, singing in an a cappella rock choir and generally creating gentle havoc with her family.
Denis Lacombe graduated with his MD from the University of Marseilles (France) in 1988 and obtained a Master Post-Doctoral Fellowship at The Roswell Park Cancer Institute (Buffalo, NY USA) for research in pharmacology and pharmacokinetics from 1989 to 1991. From 1991 to 1993, he worked as a Clinical Research Advisor in charge of the development of a new drug in oncology in the pharmaceutical industry.
Dr Lacombe joined the EORTC in 1993 as a research fellow and quickly became a very active and productive Clinical Research Physician involved in the conduct of clinical research from protocol development through publication for a number of oncology indications from phase I to phase III.
Dr Lacombe contributed to the strategic evolution of the EORTC pan-European clinical and translational research infrastructure by setting up various supportive assets such as regulatory and Pharmacovigilance expertise, as well as partnership models with the pharmaceutical industry.
Dr Lacombe rose to the position of Director EORTC Headquarters in 2010, and in April 2015 was appointed EORTC Director General. In his current position, Denis Lacombe is now involved in the coordination and administration of all EORTC activities in order to promote the EORTC as a major European organization in Cancer Clinical and Translational Research and is responsible for the organization of scientific activities, public relations and medium term strategies as defined by the EORTC Board as well as for internal and external communications.
Dr Lacombe is the author of well over 100 peer reviewed publications and communications that have had a positive impact on the future of cancer therapy.
|University Hospital of Lord’s Transfiguration
|Hospital Pharmacy Specialist,
|Senior Pharmacist, Clinical Trials
|Chair of MASHA project
Ms. Korczowska received her Master of Pharmacy degree in 2001 from the Poznan University of Medical Sciences. She has been working in hospital pharmacy for more than 15 years, with a special interest in oncology. In 2009 she qualified as a specialist in hospital pharmacy and in 2011 she started her doctoral thesis at the Poznan University of Medical Sciences evaluating environmental contamination with antineoplastic drugs in Polish hospitals.
Ms. Korczowska is an active member of Polish Pharmaceutical Society, Polish Association of Oncology Pharmacists and European Society of Oncology Pharmacy (ESOP). Since 2008, she has been a member of the Masterclass Faculty at ESOP.
Her pharmacy experience includes taking leadership roles in the safe handling of antineoplastic drugs and in the running of clinical trials in a hospital setting. She is the designated member of pharmacy staff for clinical research at the University Hospital of Lord’s Transfiguration in Poznan. She was also a lead investigator in the first study conducted in Poland assessing cytotoxic contamination in Polish hospitals.
Ms. Korczowska is an author of several articles and scientific abstracts, and the co-author of Polish Standards in Oncology Pharmacy (third edition). She has delivered more than 30 scientific presentations at local, national and international symposia, and she has participated in over 40 scientific international and Polish conferences in the areas of pharmacy and oncology. At the 17th Congress of EAHP, Milano, 2012, Ms. Korczowska was nominated for a poster award (“Evaluation of surface contamination with eight antineoplastic drugs in preparation and administration areas in four Polish hospitals”). In 2016 she was awarded 3rd Prize for the abstract and poster entitled “Contamination with cytotoxic drugs in the workplace – ESOP pilot study” presented during the 21st Congress of EAHP in Vienna.
Ms. Korczowska conducts continuing education programs for pharmacists in oncology throughout Poland and is a mentor to Polish and foreign students at the Poznan University of Medical Sciences. She participates in pharmacy training for professional work by conducting didactic classes in the field of oncology.
Ms. Korczowska is the Chair of the ESOP project (“MASHA”) monitoring environmental contamination with cytotoxic drugs in European hospitals. The objective of this work is to make recommendations which lead to improvements in the safe handling of these drugs.
Ingrid Klingmann, MD, PhD, FFPM, FBCPM
European Forum for Good Clinical Practice (EFGCP), PHARMAPLEX bvba
Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of experience in different senior medical, operational and managerial functions in pharmaceutical industry, CROs and clinical trial sites with focus on clinical trial design and management, ethical and regulatory aspects.
Since January 2003 she has her own pharmaceutical development and site management support consulting company.
Dr. Klingmann is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was and is involved in different FP7- and IMI-funded projects (ICREL, PatientPartner, PharmaTrain, EUPATI, Combacte-Magnet) and with her company in the FP7-funded paediatric LENA project and the IMI-project SPRINTT. Her broad professional background as physician with experience in patient care, clinical development, site management and patient engagement enables Dr. Klingmann to bridge the gaps between the interests and skills of all different stakeholders in medicines development with the aim to develop new patient-relevant treatments more efficiently.
Dr. Klingmann is also President of PharmaTrain Federation and teaches different topics in diploma and master courses at the University of Bonn, Germany, University of Basel, Switzerland, and the Université Libre de Bruxelles, Belgium.
Eric Klasen is Vice President, Regulatory Affairs and Quality with Medtronic International Trading Sàrl, Switzerland and President of Medtronic BioPharma Europe. He is also an active member of MedTech Europe as well as Board Member of the European Forum of Good Clinical Practice (EFGCP).
Prior to joining Medtronic he headed up Global Drug Regulatory Affairs at Novartis Consumer Health in Nyon, Switzerland. He also held the positions of Director Regulatory Compliance of Chiron Vaccines SpA, Director of R&D and Quality at Serono SA in Switzerland and Italy as well as Head of the Immunochemistry Department of T.N.O. Medical Biological Laboratory in Rijswijk, The Netherlands. Eric has also worked as an independent consultant to the pharmaceutical and diagnostics industries.
A native of the Netherlands, Eric holds a M.Sc./Drs. in Genetics/Molecular Biology and a B.Sc. in Biochemistry from the University of Leiden, The Netherlands.
Tanja Keiper, molecular biologist by training holds a doctoral thesis in internal medicine and is since 2005 working in the healthcare industry in various positions within clinical research & development. She joined Merck KGaA in 2007 and is since 2014 member of Global Clinical Operations External Innovation and focusing on patient centricity and innovation in clinical development. Tanja has shown her expertise in patient centricity/patient engagement in various IMI projects.
Barney Horne is Senior Director QA for Daiichi Sankyo, based in UK. He is a member of the Research Quality Association (RQA) GCP Committee and represents RQA at the MHRA Stakeholder Engagement Meeting.
Barney started his industry career with ICI Pharmaceuticals and held various posts in pharmaceutical development, clinical monitoring and international trials management, before joining Global Clinical Quality Assurance in 1995.
Barney left AstraZeneca in 1999 to join Janssen Pharmaceutica as QA Director, based in Beerse, Belgium, returning to Cambridge, UK in 2001 as Director (later Executive Director) of Clinical Quality Assurance for PPD Global. In 2011 he joined Novartis as Global Head GCP-PV Auditing for Novartis Pharma AG in Basel, Switzerland, and moved to Daiichi Sankyo in December 2013.
As well as his activities with RQA, Barney is a member of the Royal Pharmaceutical Society of Great Britain (RPSGB), and the Drug Information Association (DIA). He has served on conference programme committees for RQA, SQA and DIA, organised GCP specialist meetings and training events, and presents at regional and international QA meetings and conferences.
Graduated in physics at the University of Vienna, worked 14 years as medical physicist in the field of nuclear medicine, 10 years as managing editor of a medical journal.
Since 2010 senior staff member of the ethics committee of Vienna Medical University, involved in all project-related and administrative issues, with special expertise in the field of informed consent. The EC of Vienna Medical University is the largest ethics committee in Austria, responsible for the assessment of about 1200 studies per year, ranging from PhD theses to multi-center clinical trials.
Co-chair of the EFGCP Ethics Working Party, has been co-chair of the EUPATI Ethics Panel
Dr. François is specialist in Intensive Care medicine and Anaesthesiology at the University Hospital of Limoges, France. He works in a 22 bed medical/surgical ICU and is the head of the Limoges Clinical Investigation Center (Inserm CIC-P 1435) of which main expertise is Infectious Diseases in critically ill patients. He has been national coordinator for numerous emergency trials especially in Sepsis, VAP and VAP prevention, and has participated in several advisory boards for Sepsis and VAP multinational trials, independent Clinical Evaluation Committees and Adjudication Committees. He is author of many publications in Infectious Disease in the ICU especially about Sepsis and VAP and is also reviewer for several medical journals in the ICU field. He has an expertise in the practical bedside organization of clinical research in the ICU. He created the CRICS network dedicated to clinical research in Sepsis trials in 2007 and is now co-leading the French TRIGGERSEP research network (F-CRIN certification within ECRIN) which integrate all research activities in Sepsis from basic science to clinical trials. Since 2012, he is co-coordinating the COMBACTE consortium within the IMI framework.
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held various positions in monitoring, Project Management, and more recently in GCP Compliance and Training Management.
Gail was promoted to Senior Inspector in October 2005 and accredited to perform Pharmacovigilance Inspections in November 2007. In June 2010 Gail was promoted to Expert Inspector, GCP.
Gail holds a BSc (hons) in Applied Biology and a certificate in Human Pharmacology
Dr Brian Edwards:
– 1980 – 1994 Guy’s Hospital Medical School followed by hospital medicine and clinical research in London, Birmingham, and Manchester
– 1994 -1999 Senior Medical Assessor Pharmacovigilance Assessment Group UK Medicines Control Agency
– 1999 – 2005 Senior Medical Director– Parexel Scientific and Medical Services
– 2005 – 2007 Deputy Qualified Person for pharmacovigilance for Janssen Cilag
– Since July 2007 Principal Consultant in Pharmacovigilance and Drug Safety with NDA Regulatory Science Ltd based in UK.
Director of ISoP Secretariat Ltd and Advisory Board Member of ISoP
Vice President Pharmacovigilance & Drug Safety in the Alliance Clinical Research Excellence and Safety (ACRES) and Chair of UK Pharmaceutical Human Factors & Ergonomics group
Nicky Dodsworth is currently Vice President Quality Assurance, Risk & Compliance for Premier Research with responsibility for pharmaceutical and medical device studies.
Nicky is an active member of European Forum for Good Clinical Practice (EFGCP), in 2011 she was appointed Chair of the Education Working Party and is a member of the Audit Working Party. Nicky has conducted widespread training for various groups and has presented in 16 different countries. She is a Senior Associate Member of the Royal Society of Medicine. In 2009 Nicky became a Chartered Scientist, an award from the Science Council in the UK which is awarded to individuals who are professional scientists practicing and/or advancing science and for whom this is an integral part of their daily work. Nicky has worked closely with the Institute of Clinical Research since 1996, she is currently Co-Chair of the GCP Forum and she also works closely with the Ethics Forum. In July 2011, Nicky became a member of the Research Quality Assurance, West & Wales Organising Group which promotes information exchange at a regional level.
Nicky has written many publications, including addressing risk mitigation in clinical research, quality by design and risk management, risk based approaches, quality culture, training and education, auditing and inspections, fraud and misconduct, ISO 14155, implementing quality in times of change, improving quality through metrics, standards for Ethics Committees in Europe, Standard Operating Procedures and running trials in Eastern Europe and Russia. Nicky has assisted in preparation of the 4th Edition of Fraud and Misconduct, Royal Society of Medicine Press, by writing the chapter on enhanced audits. In 2016 she published a chapter of a book on Audits and Inspections commissioned by the Oxford University Handbook Series – the Oxford Handbook of Clinical and Healthcare Research. Nicky also wrote Chapter 11 on Good Clinical Research Practice for the 2017 edition of Clinical Research Manual. She has given over 80 lectures and presentations with various audiences including academia and the NHS in the UK, on clinical trials, good clinical practice, good clinical laboratory practice, quality, risk assessment, informed consent, audits and audit findings, fraud and misconduct and ethics in clinical research.
Myra Daridan is a clinical research professional with more than 25 years experience within the industry, in CROs and as a consultant in clinical research. She obtained her PhD in Biophysics at King’s College London, and thereafter was active in both medicines and medical device clinical research in Europe. She has headed European clinical research activities as a at Alcon, then as a Director at Boston Scientific, and as a VP of Clinical and Regulatory Affairs at CERC before founding Clinical Research Consultants in 2010 in Paris, France, which she has been managing since. Myra equally headed Clinical Affairs departments as Transitional Manager for reputed European companies. She has also participated to the works of the ISO14155 revision committee at AFNOR standards organization, and has been a member of the French government Economic and Social Council. Myra is an expert to the European Commission since 2012 in the evaluation of Health projects.
Dr. Kerstin Breithaupt-Grögler (MD) studied medicine at J.W. Goethe-University Frankfurt, Germany (1976-1983). After state approval as physician and medical thesis (doctor of medicine, summa cum laude) worked as Junior Research Fellow at Center of Physiology, University Frankfurt (1983-1985).
From 1986 to 1995 Research Physician / Clinical Investigator at Center of Cardiovascular Pharmacology, Mainz-Wiesbaden, Germany and Board Certification in Clinical Pharmacology. Since 1995 working as independent consultant in clinical pharmacology and medical writer. More than 20 years experience in planning, conduct, evaluation and reporting of Phase I to III clinical trials, writing of expert reports including safety dossiers, clinical summaries / overviews, scientific presentation and publication (28 original papers, more than 80 abstracts and oral presentations).
Founding member of the German Association of Applied Human Pharmacology (AGAH e.V., Hamburg), Board Member since 1997; President 2012-2014, Past President since 2014. AGAH Delegate to EUFEMED (European Federation for Exploratory Medicines Develop-ment, Brussels). Member of scientific programme committees, conduct of workshops and conferences, training courses in exploratory medicines development, qualification of study teams.
Tamás Bereczky currently works as the communications advisor of the European AIDS Treatment Group (www.eatg.org), the largest European network of individuals living with HIV, and as the communications officer and trainer of the European Patients’ Academy for Therapeutic Innovation EUPATI. HIV positive since 2003, he served as a member of the board of directors of the EATG for almost 4 years, and also served the co-chair of the European Commission’s Civil Society Forum on HIV/AIDS between 2013 and 2015.
Originally a linguist (ELTE University of Budapest), and psychologists (Open University), Tamás is set to defend his PhD based on research into the significance and perspectives of patient organizations in Europe early 2018. In addition to his work as a communications person, he also works as an advisor to EACS, UNAIDS and ECDC in matters concerning HIV, HCV, men having sex with men, substance use, and health policy. He has also been the editor and developer of the EATG website for 3 years, and has been producing HIV and hepatitis C advocacy videos, websites and blogs in his native Hungarian.
Some recent and upcoming publications of Tamás discuss the standing and possibilities of patient organisations in neoliberalism; the use and utility of sociodramatic techniques in patient education; and the significance of social media in clinical development; the health issues of men having sex with men from a queer theory perspective; the discursive positioning of HIV/AIDS thirty years into the epidemic; and a training manual for patient organisations on the methods and processes in medicine pricing, the affordability of medicines, and practical advocacy for more affordable medicines.
Tamás speaks fluent German, English and Hungarian. He is father to an adult daughter and lives with his partner and a mischievous cat in Budapest, Hungary.
You can read some of Tamás’s work here:
Dimitrios Athanasiou holds a BA in Business Administration and an MBA in Financial Management. He speaks three European languages and has more than 25 years’ experience with international business projects, working in various countries in consulting, developing and reorganizing companies.
When his son was diagnosed with Duchenne Muscular Dystrophy, a fatal and incurable rare disease, he become a strong international patient advocate in Duchenne and Rare Diseases.
Having a passionate personality and technocratic background, he educated himself with basic rare disease and advocacy knowledge via the EURORDIS Summer School and then with the 14 month Patient Expert Course of the European Patient Academy of Therapeutic Innovation (EUPATI) acquiring basic biotech and regulatory knowledge, where he served as a Member of EUPATI’s Course Committee for the next year, representing the patient voice. Being a EUPATI fellow, he established the Greek EUPATI National Liaison Team.
Locally in Greece he established the Parent Project MDA HELLAS, creating an active network of patient advocates, and became a board member of the Duchenne Global Organization, United Parent Project MD (UPPMD) promoting a vibrant network of patient organizations where children with DMD will have access to the best care irrelevant to where they live.
In his role as a patient advocate, he interacts with Regulators, HTA authorities, Industry and Academia promoting the rights of patients with rare diseases to have access to the best care possible and to new, safe and affordable drugs for rare diseases.
As a strong and commited patient advocate for DMD and rare diseases, he serves the patient community through various roles. He is a EURORDIS EPAC/TAG member, he serves in the Board of the European Forum for Good Clinical Practice (EFGCP), Co-Chairing the Children Medicines Working Party (CMWP), Patient Advisor in TREAT-NMD Advisory Committee for Therapeutics (TACT), DIA’s Program Committee Member and many others.
In 2014 he was nominated patient expert by EMA for DMD and has participated in several of EMA’s Scientific Advice, SAG, Protocol Assistance and CHMP pilot meetings for Duchenne, providing the essential patient representative perspective when companies request regulatory advice or approval.
He currently serves as PDCO member in EMA representing EURORDIS.