Mastering the New Time Pressure on Human Pharmacology
Focused strategies based on lessons learned in the pandemic
Scientific and Programme Committee
CRS Clinical Research Services Berlin GmbH
Dr. Sybille Baumann is medical doctor by training and is board certified as …
Dr. Sybille Baumann is medical doctor by training and is board certified as anaesthesiologist and clinical pharmacologist. Her working experience includes about ten years in anaesthesiology in several institutions including the University Hospital at Homburg/ Saar. After her clinical career Dr. Baumann gained experience in clinical trials first as Investigator at the former IKP Bobenheim GmbH and later as Deputy Medical Director at CRS Mannheim GmbH where she performed and supervised phase I/IIa trials in healthy subjects and patients from planning until reporting. In January 2016 she joined her present position as Medical Director at CRS Berlin GmbH, a unit with special focus on First in Human Trials and clinical trials in the field of women´s health. Sybille is President of the German Association of Applied Human Pharmacology (AGAH e.V./ Hamburg) since 2022.
-kbr- clinical pharmacology services
Dr. Kerstin Breithaupt-Grögler (MD) studied medicine at J.W. Goethe-University Frankfurt, Germany (1976‑1983). After state approval…
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 clinical trials, writing of expert reports including safety dossiers, clinical summaries / overviews, scientific presentation and publication (30 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 2014-2018, since 2018 AGAH Regent / Consultant to the AGAH Board. AGAH Delegate to EUFEMED (European Federation for Exploratory Medicines Development, Brussels). Member of scientific programme committees, conduct of workshops and conferences, training courses in exploratory medicines development, qualification of study teams.
Independent Senior Consultant
Dr. Henri Caplain, MD, MSc is a physician, senior adviser in early clinical development strategy and drug risk management. He is the…
Dr. Henri Caplain, MD, MSc is a physician, senior adviser in early clinical development strategy and drug risk management. He is the past President of the ‘Association Française de Pharmacologie Translationnelle (AFPT) - Le Club Phase 1’ founding member of EUFEMED. After 15 years as primary investigator for early phase clinical trials and medical scientific director within an International CRO ‘Aster-Cephac Group’, he joined Sanofi-Synthelabo Research as head of clinical pharmacology and Exploratory, member of the R&D board. He became associate VP, deputy-head of worldwide clinical pharmacology for Sanofi-Aventis R&D, then head of the risk management center of excellence within Sanofi, member of the Benefit-Risk Assessment Committee chaired by the Sanofi Chief Medical Officer (CMO).
QPS Netherlands B.V.
Izaak (Sjaak) den Daas is a Clinical Pharmacologist and Director Patient Studies at
QPS Netherlands B.V….
Dr. Izaak den Daas is a Clinical Pharmacologist and Director Patient Studies at QPS Netherlands, an early phase CRO in Groningen, The Netherlands. He has been working for QPS for more than 17 years in various senior functions. He is a board member of EUFEMED and member of ACRON. Before his time at QPS he worked in R&D at GSK, Merck KGaA and Bavarian Nordic.
Eurofins Optimed
Dr Yves Donazzolo is a medical doctor and a clinical pharmacologist. In 1990, he co-founded Eurofins Optimed, a company…
Dr Yves Donazzolo is a medical doctor and a clinical pharmacologist. In 1990, he co-founded Eurofins Optimed, a company dedicated to the early clinical development of drugs and health products in Europe with particular expertise in early development studies, from First-into-Human to Proof-of-Concept trials. He has served as Principal Investigator in several hundreds of trials.
He has been a lecturer in several teaching programs in clinical pharmacology and drug development and is responsible for a Master Module at Grenoble Alps University.
He is an active member of the French Society of Translational Pharmacology (AFPT – Le Club Phase I), where he has served as President for two terms. He has been a founding member of EUFEMED, the European Federation for Exploratory Medicines Development. In addition, he is a member of the French Society of Pharmacology (SFP), the British Pharmacological Society (BPS) and the American College of Clinical Pharmacology (ACCP).
Associate VP, Clinical Pharmacology
Paul Goldsmith is an Associate VP in Clinical Pharmacology Eli Lilly with…
Paul Goldsmith is an Associate VP in Clinical Pharmacology Eli Lilly with 24 years’ experience in the pharmaceutical industry within Neurology, Psychiatry, Respiratory and Diabetes therapeutic areas.
Niche Science & Technology Ltd.
Dr Tim Hardman is a post-doctoral scientist with knowledge of a broad range of scientific disciplines and a thorough…
Dr Hardman is a post-doctoral scientist with knowledge of a broad range of scientific disciplines and a thorough understanding of the process of drug development. He started Niche Science and Technology Ltd in 1998 and now manages a multi-disciplinary team performing specialist CRO services for pharmaceutical and academic organisations. Dr Hardman is currently the Chairman of the Association for Human Pharmacology in the Pharmaceutical Industry.
UZ Leuven, Center for Clinical Pharmacology
After obtaining a Master’s degree in Chemical Sciences Prof. Jan de Hoon was trained as a Medical Doctor and specialised in…
After obtaining a Master’s degree in Chemical Sciences Jan de Hoon was trained as a
Medical Doctor and specialised in General Internal Medicine at the University of Leuven.
Subsequently, he became a certified Clinical Pharmacologist and obtained a PhD in Medical
Sciences at the University Medical Centre of Maastricht in The Netherlands.
Jan has over 25 years of experience in clinical pharmacology, partly in industry, partly in
academia. He has a special interest in early clinical drug development including exploratory
clinical trials, first-in-human, imaging and biomarker studies.
He is a founding board member – previous president – of EUFEMED: the European
Federation for Exploratory Medicines Development (founded in 2015). He was founder of the
Belgian Association of Phase I Units (BAPU) which became part of Healixia. He is board
member of Healixia, a fellow of the British Pharmacological Society, Council member for
Belgium within the European Association for Clinical Pharmacology and Therapeutics
(EACPT) and a former board member of the Dutch Society for Clinical Pharmacology and
Biopharmacy.
At present, he is appointed as Full Professor in (Clinical) Pharmacology at the Faculty of
Medicine of the University of Leuven (KU Leuven). Since 2000 he is heading the Center for
Clinical Pharmacology, an Academic Research Organisation located in the University
Hospitals of Leuven near Brussels, with a focus on early clinical drug development.
Jan is married to Ann Van Hoof and the proud father of 3 lovely children: Pieter, Fien and
Emma.
Pharmaplex bvba
Dr Ingrid Klingmann is a Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of…
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-NET, PARADIGM, ConCEPTION, PharmaLedger) and with her company in the FP7-funded paediatric LENA project. Her broad professional background as physician with experience in patient care, clinical development, site management, regulatory affairs, clinical research ethics, 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, the not-for-profit organisation focussing on global standardisation and improvement of post-graduate training in medicines development sciences. She also teaches on different clinical research and regulatory affairs topics in diploma and master courses at the University of Bonn, Germany, University of Basel, Switzerland, and the Université Libre de Bruxelles, Belgium.
SGS Belgium NV
Dr Jelle Klein is Medical Director at SGS…
Dr Jelle Klein graduated as Medical Doctor in 2016 from the University of Antwerp with a Master of Science in Medicine. Prior to this, he received a Bachelor of Health from the Hanzehogeschool in Groningen in 2009. Between 2016 and 2018, he specialized in Obstetrics and Gynecology in several hospitals in Belgium. In October 2018, Dr Klein joined the SGS Phase I unit as Principal Investigator, gaining experience in the coordination and set-up of phase 0-IV clinical trials (in different area’s as immunology, dermatology, cardiology, etc.) while being responsible of the safety and wellbeing of the subjects on site as well as the collection and review of the medical clinical data. Since mid 2022, Dr Klein is CPU Medical Director, and overall responsible for medical and scientific aspects of the CPU early phase projects.
Sanofi-Aventis Deutschland GmbH
Dr Andreas Kovar, Ph.D., F.C.P., is currently head of Translational Medicine and Early Development Germany at Sanofi-Aventis…
Andreas Kovar, Ph.D., F.C.P., is currently head of Translational Medicine and Early Development Germany at Sanofi-Aventis.
Andreas was an elected member of AGAH's Board of Regents from 2001-2018 and serves as the president of AGAH since 2020. Further, he is a co-organizer of the annual PK/PD-Expert Meeting in Germany.
Biokinetica S.A.
Agnieszka Kulesza is Chief Operating Officer at Biokinetica…
Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet. Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet.
Janssen Pharmaceutica N.V. – CPU
Erik Mannaert is Deputy Head of the Janssen Clinical Pharmacology Unit since 2017. He has a tenure of 27 years with Janssen…
Erik is Deputy Head of the Janssen Clinical Pharmacology Unit since 2017. He has a tenure of 27 years with Janssen R&D, during which he had different scientific and managerial positions in the area of clinical pharmacology. Most of his experience is related to the clinical pharmacology development of compounds in internal medicine, CNS and oncology, both in early and late stages of clinical development. In addition, he has been a lecturer in clinical pharmacology at the University of Antwerp. Erik graduated as a PharmD, PhD, with expertise in analytical toxicology, from the K.U.Leuven.
Biokinetica S.A.
Ewa Urbańczyk is a Medical Analytic – MSc in Laboratory Diagnostics…
Ewa Urbańczyk is a Medical Analytic – MSc in Laboratory Diagnostics. Completed also post-graduate education in Public Health in Medical School of Jagiellonian University. She has more than 30 years experience in Pharmaceutical Industry – started her career from Medical Representatives through various positions in Marketing and Medical Department. Worked as Senior Medical Advisor in Abbott and Mylan Healthcare. She has worked for companies such as Novartis, Novartis Ireland , Solvay, Abbott and Mylan in therapeutic areas such as Women Health ,Influenza Vaccination, Immune Diseases. Took part in several launches of new products in Polish market including biosimilars. In 2021 opened new career path in Clinical Trials working as a Scientific Advisor in Biokinetica and CT auditor. Active member of Polfemed - "Polish Association for the Development of Innovative Medicines".
Centre for Human Drug Research (CHDR) — Early clinical drug research
Rob Zuiker studied medicine at the University of Amsterdam. From 2007 …
Rob Zuiker studied medicine at the University of Amsterdam. From 2007 onwards, Rob joined CHDR as a clinical research physician and has since been working on a wide range of projects. He is registered as a clinical pharmacologist since 2012, and obtained a doctoral degree for his thesis entitled “Development and use of biomarkers in clinical development of new therapies for chronic airway disease” in 2016. His current position is associate director with a special focus on project management. Next to his work at CHDR, Rob is vice president and treasurer at the Association for Contract Research Organisations in the Netherlands (ACRON).
Sanofi
Work Experience
Work Experience
Lecturer
Education
Biopharma Excellence GmbH
Dr. Michael Pfleiderer is an internationally renowned expert in regulatory affairs and development of vaccines. He is a…
Dr. Michael Pfleiderer is an internationally renowned expert in regulatory affairs and development of vaccines. He is a biologist holding a Ph.D. in molecular virology. After his university career he firstly joined the molecular biology laboratories at former IMMUNO AG, Vienna, Austria (now Shire), where he worked on various aspects related to the development and production of recombinant medicinal products including vaccines.
Since 1998, Dr. Pfleiderer had been the Head of the Human Viral Vaccines Section at the Paul-Ehrlich-Institut (PEI), German Federal Institute for Vaccines and Biomedicines. He was responsible for all issues related to vaccine licensing and regulation, for batch testing and release of vaccines as well as inspection-related aspects. His team has had a leading function as Rapporteur, Co-Rapporteur or Peer Reviewer for a significant proportion of the Marketing Authorization Applications (MAAs) for vaccines submitted to the European Medicines Agency (EMA) in London. The team also acted on behalf of Germany as the Reference Member State (RMS) for the European Union (EU) in the Mutual Recognition (MRP) or Decentralised Procedure (DP) for a broad range of vaccines, most notably tri- and tetravalent seasonal influenza vaccines as well as pandemic influenza vaccines.
Dr. Pfleiderer has thus in-depth experience as an ex-regulator as he had guided through the decision making process on the benefit-risk ratio of vaccines and also decided on regulatory, legal and administrative issues related to vaccine applications. He has performed review of all kind of life cycle applications of vaccines related to all parts of the CTD, i.e. CMC, pre-clinical and clinical modules.
Moreover, numerous scientific advice procedures related to vaccines on the national level and at the level of EMA were performed and steered by him.
Dr. Pfleiderer has actively developed and steered the European regulatory system for vaccines. He was acting as:
Dr. Pfleiderer has significantly contributed to EMA guidelines on scientific and regulatory issues related to vaccines.
The European Centre for Disease Prevention and Control (ECDC) nominated Dr. Pfleiderer as an expert for the Scientific Expert Panel on Vaccines and Immunization.
By the European Commission Dr. Pfleiderer has frequently been nominated as an expert for reviewing research proposals and progress made for supported projects within the IMI and other R&D funding programs steered by the EC.
Dr. Pfleiderer has in-depth experience in laboratory analysis of vaccines, has established an accredited control laboratory for the conduct of official batch release assays according to OMCL batch release guidelines and has conducted inspections at manufacturing and testing sites of vaccine manufacturers.
At a global level he has established the WHO Collaborative Centre for Vaccine Evaluation and Standardization at PEI acting as the Head since 2014. In this function he has assisted WHO to establish their global regulatory science agenda as an important landmark of the World Health Assembly’s key project, the Decade of Vaccines, aimed at bridging numerous gaps identified that currently prevent equal access to vaccines around the world including emergency vaccines such as against Ebola and influenza pandemics.
Further to that, Dr. Pfleiderer was frequently acting as a temporary advisor for WHO and was a member of various scientific and technical advisory groups convened by WHO. Finally, he was part of WHO vaccine pre-qualification teams as well as of WHO teams assessing the functionality of National Regulatory Agencies.
Dr. Pfleiderer has acted as advisor to the German government as he was member of a number of governmental boards, in particular those dealing with issues related to pandemic influenza vaccines and pandemic preparedness planning.
For the EMA, Dr. Pfleiderer was chairing the EMA Pandemic Task Force (ETF) coordinating regulatory and scientific issues related to the influenza pandemic from 2009/2010. Under the new mandate Dr. Pfleiderer was acting as the vice chair of the EMA/ETF. He was also acting as a Scientific Board member of governments and institutions outside Germany.
He has published numerous articles related to the areas of expertise as described above, gives invited talks to learned societies and contributes to conferences on all aspects of development, testing and regulatory affairs of vaccines.
Dr. Pfleiderer has frequently been invited as a visiting lecturer by various academic institutions inside and outside of Europe.
By 1st of March 2016 Dr. Pfleiderer has joined the team of Biopharma-Excellence, Munich, acting as a Principal Consultant.
Grünenthal GmbH
Dr. Jens Rengelshausen leads the Clinical Science team at Grünenthal GmbH in Aachen, Germany. He is a physician with…
Dr. Jens Rengelshausen leads the Clinical Science team at Grünenthal GmbH in Aachen, Germany. He is a physician with board certification in clinical pharmacology. Jens has more than 20 years of experience in clinical drug development and translational science in the therapeutic areas of pain and inflammation. He has contributed to the clinical development of more than 10 novel compounds focusing on efficient first-in-human transition, proof of concept and marketing authorization. Dr. Rengelshausen is also a board member of the German Association for Applied Human Pharmacology (AGAH e.V.).
SocraMetrics GmbH
Professional Appointments:
since 05/2020 Senior Project Manager, SocraTec R&D…
Professional Appointments:
since 05/2020 Senior Project Manager, SocraTec R&D, Oberursel, Germany
04/2017-04/2020 Project Manager, SocraTec R&D, Oberursel, Germany
02/2017-03/2017 Pharmacist in a community pharmacy, Groß-Gerau, Germany
11/2016-01/2017 Pharmacist in a community pharmacy, Weiterstadt, Germany
Education, Academic Degrees:
2016 Degree and licence as pharmacist (Approbation)
05/2016-10/2016 lnternship: community pharmacy, Weiterstadt, Germany
11/2015-04/2016 lnternship: pharmaceutical industry, lnfectoPharm, Heppenheim, Germany
2011-2015 Study of pharmacy at Johann-Wolfgang-Goethe-Universität, Frankfurt, Germany
2011 University entrance qualification, Weiterstadt, Germany
Research Interests, Experiences
Phase I clinical trials with focus on bioequivalence assessment and determination of local tolerability and adhesion properties of dermal administered dosage forms (patches)
Experiences with FDA relevant clinical trials
SocraMetrics GmbH
Barbara Schug studied pharmacy at Rheinische Friedrich-Wilhelm-Universität, Bonn, she received a scholarship from the…
Barbara Schug studied pharmacy at Rheinische Friedrich-Wilhelm-Universität, Bonn, she received a scholarship from the "Studienstiftung des Deutschen Volkes" and was awarded a doctor’s degree for experimental pharmacological work.
She started her professional career at Zentrallaboratorium Deutscher Apotheker, Eschborn. In 1998 she founded, together with Prof Dr Henning Blume, an independent research institute, SocraTec R&D. In 2007 she founded SocraMetrics, an independent biometrical institute. She is currently managing shareholder in both companies.
Her area of work covers the planning and realisation of early phase (I and II) trials in healthy subjects and patients and she is also responsible for phase-III and phase-IV studies realised by her companies.
Dr Schug is a member of numerous national and international scientific societies, including Deutsche Pharmazeutische Gesellschaft (DPhG)[1], Arbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH)[2], Deutsche Gesellschaft für Pharmazeutische Medizin (DGPharMed)[3], European Federation of Pharmaceutical Sciences (EUFEPS) and Gesellschaft für Dermopharmazie[4].
She was president of AGAH in the past and has been an active member of the organisational committee of the German Pharmacokinetic / Pharmacodynamic Experts Conference for many years. Furthermore, she is active member of the EUFEPS Network on Bioavailability and Biopharmaceutics and in this function she is chair of the Global Bioequivalence Harmonisation Conference (next: Dec 2021 in Amsterdam, USA). Furthermore, she is co-founder and active member of the EUFEPS Network on Dermatopharmacy.
[1] German Pharmaceutical Society
[2] Association for Applied Human Pharmacology
[3] German Society for Pharmaceutical Medicine
[4] Society for Dermopharmacy
Biopharma Excellence GmbH
Dr Diane Seimetz is a leading drug development and regulatory expert with proven track record bringing…
Dr Diane Seimetz is a leading drug development and regulatory expert with proven track record bringing first in class products from idea to approval.
Dr Diane Seimetz has over 22 years of global drug development, regulatory affairs and management experience in the biopharmaceutical industry. She is co-founder and CEO of Biopharma Excellence, THE consulting company for biopharmaceutical drug development and regulatory strategies.
Since the inception of Biopharma Excellence in 2013 she supported more than 150 clients in bringing their biopharmaceutical products to the clinical trial stage or to approval. Of note, she supported the development and regulatory strategy for the first genome edited product of a commercial sponsor using the Crispr/Cas technology.
Since 2017 she is member of the Decision Board of the Helmholtz Validation Fund, a fund that has been implemented to bridge gaps between scientific findings and their commercial applications. Furthermore, she is advisory board member of the Aglaia Oncology Fund.
Before founding Biopharma Excellence, she was Executive Vice President and Chief Scientific Officer of the Fresenius Healthcare group (Biotech division). Together with her team she developed on an international level first in class biopharmaceutical products, such as the first bispecific, trifunctional antibody. Besides the novelty of the drug format this development program involved the implementation of a new clinical trial endpoint as well as a tumor-histology independent indication. After approval in the EU, this program was awarded the “Prix Galien” which honors outstanding research and innovative drug development. In addition, during her industry career she was closely involved in the successful launch of a first in human study for one of the first genetically engineered cell therapy products in Germany.
Dr Diane Seimetz received her degree in pharmaceutical science from the University of the Saarland and completed her PhD at the University of Heidelberg. Her research work was conducted at the German Cancer Research Center and the Johns Hopkins University in Baltimore (USA).
Federal Institute for Drugs and Medical Devices BfArM
Photo and CV n/a
Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet. Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet.
Consultant
Prof. Dr. med. Hildegard Sourgens is a board-certified Clinical Pharmacologist and board-certified Pharmacologist and…
Prof. Dr. med. Hildegard Sourgens is a board-certified Clinical Pharmacologist and board-certified Pharmacologist and Toxicologist. She was head of an industry-owned Research Institute for Clinical Pharmacology and head of Clinical Pharmacology of a German CRO. Hildegard Sourgens is a consultant for the pharmaceutical industry since 1996 and is involved in early drug development projects as well as international and national scientific advice and approval procedures.
From 2014-2016 she served as president of the AGAH; from 2017-2019 she served as the president of EUFEMED.
For publications please see: www.sourgens.de
Richmond Pharmacology Ltd.
Dr Jorg Taubel is medical practitioner and CEO of Richmond Pharmacology, a centre of excellence for phase I, II and I…
Dr Jorg Taubel is medical practitioner and CEO of Richmond Pharmacology, a centre of excellence for phase I, II and III studies. A specialist in clinical pharmacology, Dr Taubel has extensive experience in cardiology, neurology, gastroenterology, and ethnic bridging studies. Dr Taubel has conducted over 500 clinical trials in many therapeutic areas but currently focuses on heart failure and diabetes.
Dr Taubel is a research fellow at the Molecular and Clinical Sciences Research Institute at St George's University of London. He has a special interest in cardiac repolarisation changes related to iatrogenic interference with glucostasis. His most recent work involved dosing the first patient in a global FIH study of NTLA-2001 in patients with hereditary transthyretin amyloidosis with polyneuropathy. The first ever CRIPR treatment for TTR amyloidosis.
Dr Taubel has authored over 140 publications in peer reviewed journals and presented his research at international events in Europe, Japan and the USA.
Widler & Schiemann AG
Dr. Widler, a Ph.D. graduate from the Swiss Federal Institute of Technology (ETHZ) in Zurich, and…
Dr. Widler, a Ph.D. graduate from the Swiss Federal Institute of Technology (ETHZ) 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 35 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.
Paul-Ehrlich-Institut
Bettina Ziegele is Liaison Officer for national and international affairs at the Paul-Ehrlich-Institut (PEI) – the Federal Institut…
Bettina Ziegele is Liaison Officer at the PEI. She set up the innovation office and has many years of experience in pharmaceutical regulation and ATMP. Bettina is a member of the EU Innovation Network and Chair of the Working Group of the Simultaneous National Scientific Advice. She holds a master's degree in economics and linguistics from the University of Heidelberg.
QPS Netherlands B.V.
Izaak ((Sjaak) den Daas is a Clinical Pharmacologist and Director Patient Studies at
QPS Netherlands B.V….
Prof Jones is a visiting professor at King’s College, London and holds honorary degrees and Gold Medals from 7 universities (including the University of Athens). He is a Director of the Life Science Investment Company; Arix Bioscience plc and the Oxford based Drug Discovery.
Company, e-Therapeutics plc. He was formerly a Director of Allergan Inc. (USA) and R&D Director of The Wellcome Foundation where he led the team that discovered and developed a number of new medicines; including AZT; the first drug against the HIV/AIDS virus.
He was Chairman of the UK Government Advisory Group on Genetics Research and is currently involved in coordinating the USA: EU collaborative research projects for vaccines and therapeutic agents against COVID-19.
CSi Hamburg GmbH
Goernestraße 30
20249 Hamburg (Germany)