First name Last name Affiliation
Isabelle Abousahl Entrepreneur, Alcoam by design; Former Director Data Management, Deputy Biometry, Global Drug Development, Ipsen Innovation, France
Giuseppe Banfi General Manager of San Raffaele Foundation, Italy
Martine Dehlinger-Kremer Vice President Global Medical and Regulatory Affairs, SynteractHCR; Chair of the Paediatric Working Group, EUCROF
Horst Domdey Managing Director, BioM Biotech Cluster Development GmbH Geschäftsführer, Germany
Michael Engsig Executive Director, Clinical Management Central and Eastern Europe, PPD
Sini Eskola Director, Regulatory Affairs; EFPIA - European Federation of Pharmaceutical Industries and Associations
Giovanni Fiori President and Scientific Director at MediNeos Observational Research, Italy
Xavier Fournie Corporate Medical Director, Executive; Vice President, Global Medical Affairs - Real World Evidence, Mapi Group
Shayesteh Fürst-Ladani Managing Director SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland
Ingrid Klingmann Chairman at EFGCP, President at PharmaTrain Federation asbl, Managing Director at Pharmaplex bvba, Belgium
Andy Lawton Consultant, Former Global Head of Clinical Data Management, Boehringer Ingelheim Ltd, UK
Christoph Male Former Member of the PDCO at EMA and Associate Professor of Paediatrics, Department of Paediatrics, Division of Paediatric Cardiology, Medical University of Vienna, Austria
Anabela Marçal Head of Committees and Inspections Department, Inspections, Human Medicines Pharmacovigilance & Committees Division, European Medicines Agency (EMA)
Yoanni Th. Matsakis President TELEMEDICINE TECHNOLOGIES S.A.S.,France
Nicholas Moore Head of Pharmacology Department of the University of Bordeaux; Head of Clinical Research of the University Hospital of Bordeaux; President of the International Society of Pharmacovigilance; Member of the Advisory board of ENCePP, France
Holger Maria Rohde Director, Strategy Implementation Lead, Merck Serono | Strategy and Business Operations Global R&D
Yvonne Rollinger Managing Director, OmniComm Europe GmbH, Bonn, Germany
Ivo Schauwecker Clinical Studies Manager, AO Foundation, Switzerland
Gabriele Schwarz Head of GCP Inspectorate, German Federal Institute for Drugs and Medical Devices
Mark Turner Chair of the European Network for Paediatric Research at EMA, University, Liverpool
Jorunn Tverland Clinical Trial Manager, Dako, Agilent Technologies, Denmark
Vincent Varlet Executive Consultant www.varlet.paris – business transformation for healthcare companies
Alan Yeomans Quality Manager, PCG Solution; representing EUCROF WG on NT
Gianluca Zia CEO, Caretek s.r.l., Torino, Italy

Isabelle Abousahl

Entrepreneur, Alcoam by design; Former Director Data Management, Deputy Biometry, Global Drug Development, Ipsen Innovation, France

Isabelle Abousahl-Chaunu has about 25 years of managerial experience and leadership role within Clinical Research organisations, more specifically in the following functions: Clinical Pharmacology; Clinical Operations; Drug Development Resource Planning; R&D Data Management.

She has developed over years an expertise in clinical studies, from phase 1 to real world studies, including the registration process for market authorisation in various geographies.

Engineer by background, she has developed a strong expertise in data management and eClinical information systems.
Isabelle is a certified Data Privacy Professional for Europe, continuing her cursus in Privacy Program Management and Privacy IT.

After many years of employment in the pharmaceutical industry (Novartis, Phase Forward, Sanofi and Ipsen), her objective is now to use her experience and skills to advance a new generation of clinical data solutions, supporting the innovation in clinical research, with a strong focus on clinical research site needs, and protective of the patient rights. She is the founder and owner of a new company: “alcoam by design” which aims at providing “data solutions for intelligent drug development”.

Data Privacy
Tuesday, 18 October, 15:05 - 15:30

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Prof. Giuseppe Banfi, MD, PhD

General Manager of San Raffaele Foundation, Italy

He was graduated cum laude in Medicine and Surgery on 1984 at University of Pavia and postgraduated in Public Health on 1988 at University of Milan.

He had wide work experience in laboratory medicine department in the Scientific Institute San Raffaele Hospital and in direction of hospitals at S. Maria Clinic, Institute Villa Aprica (Como) and, finally, at Galeazzi Orthopedic Institute in Milan.

He was Professor of Clinical Biochemistry and Clinical Molecular Biology at School of Medicine at University of University of Milano from 2006 to 2014 and now at University Vita-Salute San Raffaele.

Management skills
Director of Scientific Research programs at IRCCS, (Scientific and Teaching Hospital) Galeazzi Orthopaedic Institute from May 2007
Director of Scientific Research programs at Gruppo Ospedaliero San Donato Foundation from September 2008
General Director of Fondazione Centro San Raffaele from May 2012
Member of Board of directors of Fondazione Instituto Insubrico Ricerca per la Vita Foundation from June 2012

He was specific experience and knowledge on clinical and basic research management and on clinical experimental medicine organization and management.

Big Data-Big Opportunity for Patient Associations and Clinical Trial Center
Tuesday, 18 October, 15:30 - 15:55

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Dr. Martine Dehlinger-Kremer

Vice President Global Medical and Regulatory Affairs, SynteractHCR
Chair of the Paediatric Working Group, EUCROF

Dr. Martine Dehlinger-Kremer has nearly 30 years of experience in the clinical research industry. including more than 25 years of progressively higher levels of Regulatory and Medical  Affairs leadership responsibility. For 21 years, she served as a vice president of International and Global Regulatory Affairs and Global Medical Affairs at various CROs headquartered in the U.S.

Dr Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars, from early development stages through clinical studies and final registration. She has participated in more than 100 New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) in local and common technical document format, electronic common technical document (eCTD) and NeeS format; in the maintenance of products on the market and in numerous clinical studies across all phases.

Dr. Dehlinger-Kremer has seen the evolution in complexity of trials and the impact of global trials on innovation. She has served as Chair of the Paediatric Working Group of EUCROF (the European CRO Federation) since 2008 and has influenced the standards, protocols and number of trials conducted for drugs being administered to children. Dr. Dehlinger-Kremer is also Member of Working Parties of Enpr-EMA  (European Network of Paediatric Research at the European Medicines Agency) and Member of Children’s Medicines Working Party of EFGCP (European Forum for Good Clinical Practice).

Dr Dehlinger-Kremer was Named One of PharmaVOICE 100’s Most Inspiring People in Life Sciences (Industry leader recognized for impact, experience and advocacy in clinical research) in August 2015.

Dr. Dehlinger-Kremer holds a doctorate in sciences from the University of J.W. Goethe in Frankfurt, a general academic studies degree in neurophysiology from the Louis Pasteur University in Strasbourg, France, and a Master of Science from the University Moulin de la House in Reims, France.

Feasibility and challenges with paediatric clinical trials
Tuesday, 18 October, 12:05 - 12:30

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Horst Domdey, Prof. Dr.

Managing Director, BioM Biotech Cluster Development GmbH Geschäftsführer, Germany

Horst Domdey, a trained biochemist, held research positions in Germany, Switzerland and the United States, before he became Professor for Biochemistry at the University of Munich in 1994. In the same year he co-founded Medigene, one of the first biotech companies in Germany. In 1996 he successfully led the Munich Biotech Initiative into the German BioRegio Competition. Since 1997 he has been the Managing Director of BioM, the cluster development and management organization of the Munich Biotech Cluster. Since 2006 he also manages the Bavarian Biotechnology Cluster. Since 2003, he is the scientific director of the Bavarian Genome Network BayGene, since 2011 the coordinator of the Bavarian Center for Molecular Biosystems BioSysNet. He has been cofounder of BIO Deutschland, of the Association of the German BioRegions and of the Council of the European BioRegions (CEBR). In 2010 the Munich Biotech Cluster became – under his leadership – one of the winners in the German Leading Edge Cluster Competition. Since 2013 he is chairman of the Supervisory Board of Medigene AG.

Personalized Medicine: With Big Data to Better Health?
Tuesday, 18 October, 14:40 - 15:05

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Michael Engsig

Executive Director, Clinical Management Central and Eastern Europe, PPD

Michael Engsig is currently Head of Clinical Management for Central and Eastern Europe in PPD where he provides strategic direction, leadership and management of the Clinical Management organisation.
Prior to joining PPD, Michael came from Takeda Pharmaceuticals where he held various positions through the last 12 years, most recently as head of the established product portfolio for the emerging markets. From 2007 to 2011 Michael was leading the global clinical operations in Nycomed Pharmaceuticals (later acquired by Takeda). From 2011 to 2014 Michael was responsible for establishing Takeda’s Russian Innovation Centre focused on local product development including clinical development programs for Russia and the CIS region.
Through his career Michael have worked with clinical development in most parts of the world and today brings a perspective from both the sponsor/client as well as the provider side.
In his early career Michael has worked with early stage drug discovery in the biotech industry as well as in investment banking as biotech and pharma equity analyst.
Michael holds a Master of Science in Biotechnology from the Technical University of Denmark as well as a Graduate Diploma in Business Administration (Organisation and Management) from Copenhagen Business School.

Key Note Speech
Monday, 17 October, 12:45 - 13:30

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Sini Eskola

Director, Regulatory Affairs; EFPIA - European Federation of Pharmaceutical Industries and Associations

Sini Eskola is working as Regulatory Affairs Director at European Federation of Pharmaceutical Industries and Associations (EFPIA) since Feb 2014. She has a degree in pharmaceutical sciences (M.Sc) from the University of Helsinki. In EFPIA her main focus areas are leading and coordinating the regulatory related policy and advocacy activities on clinical trials and clinical trial data transparency, pharmacovigilance, regulatory information management and environmental, health and safety aspects. She has previously worked over 5 years at AstraZeneca R&D Global Regulatory Affairs in Sweden and prior to that as an Executive Director of Finnish Pharmacists’ Society. She has a vast experience as practicing community pharmacist. She is since 2011 a member in Executive Committee of Industrial Pharmacy Section of International Pharmaceutical Federation.

Regulation 536/2014: Status Quo from EFPIA perspective
Monday, 17 October, 13:30 - 13:55

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Giovanni Fiori, PhD, MPH

President and Scientific Director, MEDINEOS Observational Research, Italy

He is the founder and Scientific Director of MediNeos Observational Research. He has an academic background in epidemiology and human populations biology. His current main scientific interests are clinical epidemiology (innovative study designs and analytical methods), outcome and health services research. He is the chairman of EUCROF Late Phase working group. He is also the national coordinator of the Observational Studies Working Group of the Italian Society for Applied Pharmacological Sciences and active member of several scientific organizations (ISPOR, ISPE, SIF, SISMEC). He is regularly invited as a lecturer professor for Master Courses in experimental medicine and clinical research offered every year at the University of Milano Bicocca and at the Catholic University “Sacro Cuore” in Rome. He is the author of several scientific publications and lectures both at national and international congresses.

Non-interventional Studies: Different Types - Different Challenges
Monday, 17 October, 16:40 - 17:05

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Dr. Xavier Fournie, M.D.

Corporate Medical Director, Executive
Vice President, Global Medical Affairs - Real World Evidence, Mapi Group

As Mapi Group Corporate Medical Director since January 2008 and Executive Vice President of Mapi Real World Evidence since 2009, Dr. Fournie plays a leading role in the development and maintenance of professional relationships with a variety of audiences (including medical/scientific community, health authorities, patient advocacy groups and Industry), oversees medical monitoring services and develops a culture of ethical and regulatory compliance across Mapi business units. He provides input to successfully bridge clinical, commercial and legal considerations. He has held various posts over his three decades of tenure with the Mapi Group including market research and clinical research project management clinical operations leadership, general management of central lab activities, medical direction, Quality Assurance and Regulatory Affairs direction, and pharmacovigilance management. From 2001 Dr. Fournie led the development of an independent unit within the Mapi Group, ProClinica™, dedicated to multi-country direct-to-patient contact management for proactive PRO data collection and patient assistance in studies. Dr. Fournie has practiced as a GP for 4 years in hospitals and private practices in France and Germany. He has additional qualifications in Medical Law (Forensic Medicine), Sports Medicine, and Aviation Medicine. He is also an active member of the ENCePP Working Group 1 “Research Standards and Guidances” and of the French and European CRO federations (AFCROs/EUCROF).

Interventional Vs. Non-Interventional Study Classification in the European Union: Would my Study Remain Non-Interventional if I use Direct-to-Patient Contact Methods?
Monday, 17 October, 17:30 - 17:55

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Shayesteh Fürst-Ladani

Managing Director SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland

Shayesteh is the CEO and founder of SFL. She leads the team at SFL and provides global strategic support for the development of healthcare products. Shayesteh has longstanding experience in formulating global regulatory strategy for drugs, orphan drugs, drug & device combination products, borderline products, medical devices, in vitro diagnostics (IVDs) and advanced therapy medicinal products (ATMPs).

She has extensive experience in negotiating companies’ interests at a senior level in meetings with regulators. Shayesteh has been involved in reviewing and assessing the impact of European and US legislation, such as the Cell & Tissue Directive, the Advanced Therapy Medicinal Products Regulation, the Orphan Medicinal Product Regulation, and reviewing requirements impacting Drug & Device Combination Products, Personalized Medicine and HTA. Shayesteh held several management positions within the pharma, biotech and medical device sectors before founding SFL.

Before founding SFL, Shayesteh hold senior positions in various biotech and major pharmaceutical companies as Head of Global Regulatory Affairs and Head of Regulatory Affairs for Development Products.

She is Chair of Program Committee at Medtech & Pharma platform, an active member of European biotech Trade Association EuropaBio and chaired for 3 years the Combination Products Task Force. She is frequently invited speaker and conference chair. Shayesteh is Adjunct Instructor for Regulatory Affairs at the George Washington University School of Medicines and Health Sciences.

She received her MSc in Microbiology from the University of Vienna, Austria, and an MBA from the Open University Business School, Milton Keynes, UK.

The new EU Medical Device Regulation - How will it change our lives?
Tuesday, 18 October, 11:15 - 11:40

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Andy Lawton

Consultant, Former Global Head of Clinical Data Management, Boehringer Ingelheim Ltd, United Kingdom

Andy Lawton has extensive experience in Computing, Statistics, Data Management, RDE/RDC, System Design, RBA in CSV and Clinical trials. He has previously worked with Seismic Exploration (1971-1972), National Health Service (NHS) - Consultant Statistician (1979-1984) and Global Head of Clinical Data Management at Boehringer Ingelheim (1984 – Mar 2016). He is currently Consultant and Director of Risk Based Approach Ltd.

Beyond that, Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publications is the paper with Dr. Alistair Ross on GP Audit - throughout 80's and 90's this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and central monitoring in the TIRS Journal.

Risk based monitoring, is the reality matching the model?
Tuesday, 18 October, 09:00 - 09:25

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Ingrid Klingmann, MD, PhD, FFPM, FBCPM

Chairman at EFGCP; President at PharmaTrain Federation asbl; Managing Director at Pharmaplex bvba, Belgium

Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of experience in different senior operational and managerial functions in pharmaceutical companies, CROs and academic sites, focussing on clinical trial 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. Currently Dr. Klingmann is also President of PharmaTrain Federation.  Dr. Klingmann is Module Chair in the post-graduate Master Course in Regulatory Affairs at the University of Bonn, Germany, and is lecturer in the Diploma Course in Clinical Trial Practices and in the ECPM course at University of Basel and in the Pharmed course at Université Libre de Bruxelles, Belgium.

Patient Centric approaches – an overview
Tuesday, 18 October, 14:15 - 14:40

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Christoph Male, MD, MSc

Former Member of the PDCO at EMA and Associate Professor of Paediatrics, Department of Paediatrics, Division of Paediatric Cardiology, Medical University of Vienna, Austria

Christoph Male is associate professor of paediatrics at the Department of Paediatrics, Medical University of Vienna (MUW), Austria. His scientific interest is in paediatric haemostasis & thrombosis, paediatric cardiology, drug evaluation and clinical trials methodology in children. He is actively involved in multiple academic or industry-sponsured clinical trials in children. He is executive board member of the Austrian paediatric research network (OKIDS).
From 2007-2016, Dr. Male served as Austrian delegate in the Paediatric Committee (PDCO) at the European Medicines Evaluation Agency. He is member of the Scientific Board of the Austrian Medicines Agency, chair of the working group on paediatric medicines, Austrian Paediatric Society, and paediatric member of the ethics committee of the MUW.
He currently acts as chair of the Pediatric Subcommittee of the International Society of Thrombosis & Haemostasis (ISTH).

Regulatory Situation 9 years after the implementation of the Paediatric Regulation
Tuesday, 18 October, 11:15 - 11:40

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Anabela Luis De Lima Marçal

Head of Committees and Inspections Department, Inspections, Human Medicines Pharmacovigilance & Committees Division, European Medicines Agency (EMA)

Career to date
Head of Compliance and Inspections, European Medicines Agency (2013-present)
Head of Community Procedures, European Medicines Agency (2009-2013)
Specialised Group Leader for Post-Authorisation Safety and Efficacy Central Nervous System / Endocrinology, European Medicines Agency (2001-2009)
Scientific Administrator, European Medicines Agency (1999-2001)
Scientific Administrator, Infarmed, Lisbon, Portugal (1995-1999)
Hospital Pharmacist, Dona Estefânia Hospital, Lisbon, Portugal (1991-1995)
Pharmacist, Community Pharmacy, Lisbon, Portugal (1991)

Professional certification in hospital pharmacy, Portugal (1994)
Degree in pharmacy, Portugal (1991)

The EU Portal: A Gate to Simplified Clinical Research?
Monday, 17 October, 13:55 - 14:20

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Mr Yoani Matsakis


Yoani Th. MATSAKIS is the CEO of Telemedicine Technologies, a company specialized in e-health systems and delivering EDC and ePRO solutions for clinical trials. He is also the acting treasurer of EUCROF, co-chairing the working group on new technologies and member of the AFCROs' board of directors. He graduated as space and aeronautics engineer at the National High School for Aeronautics and Space (ENSAE) in France. He then joined the French National Center for Scientific Research (CNRS) as scientist where he was in charge of an experiment onboard the MIR Space Station. He then joined CNES – Centre National d’Etudes Spatiales – as payload manager and participated to several scientific programmes in the field of space physiology and medicine.
In 1997 he founded the telematics department of the Institute of space medicine and physiology and conducted an R&D programme in the field of telemedicine that resulted in the creation of Telemedicine Technologies in March 2000.

The convergence of e-health & clinical research reshaping the stakeholders' landscape
Monday, 17 October, 17:10 - 17:25

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Prof. Nicholas Moore, MD, PhD, FRCP (Edin), FISPE

Head of Pharmacology Department of the University of Bordeaux; Head of Clinical Research of the University Hospital of Bordeaux; President of the International Society of Pharmacovigilance; Member of the Advisory board of ENCePP, France

Pr Nicholas Moore is MD, PhD, qualified in Cardiology and Pharmacology. His areas of research include drug utilisation and measure of drug exposure, drug safety and especially of low-dose NSAIDs for analgesia, measure of real-life performance of drugs within European and national Risk-Management Plans and Post-Approval Studies.

He was born in New York, USA, did his medical studies in Paris, then trained in Cardiology and Pharmacology in Rouen during which time he became vice-president of the French Association of regional Pharmacovigilance Centres and founded the European Society of Pharmacovigilance. In 1996 and after 12 years working in the department of Pharmacology and Pharmacovigilance of Rouen, he became Professor of Clinical Pharmacology at the University of Bordeaux.

Since 2003, Pr Nicholas Moore is the Director of the Department of Pharmacology. This department has over 100 members of staff and is constituted of: Clinical Pharmacology and Pharmacoepidemiology research units, Laboratories for Experimental pharmacology, Toxicology and Therapeutic Drug Monitoring as well as regional Pharmacovigilance and Pharmacodependence Centres. Pr Nicholas Moore develops fundamental and applied research projects in Phytopharmacology as a team-leader in the Experimental Pharmacology Laboratory.

Pr Nicholas Moore is involved in the advisory group of the EMEA project: "European Network of Centres of Excellence in Pharmacovigilance and Pharmacoepidemiology" (ENCePP).

He is also Head of Clinical Research of the University Hospital of Bordeauxand of the South-West France Inter-Region, member of the Hospital Board, and of the Regional Ethics Committee (DIRC, CPP SOOM3).

He is founder and President of the International Society of Pharmacovigilance (ISoP), vice-chairman of the European Association of Clinical Pharmacology and Therapeutics (EACPT), and on the board of directors of the International Society for Pharmacoepidemiology (ISPE).

He has been elected Fellow of the Royal College of Physicians of Edinburgh, Fellow of the International Society of Pharmacoepidemiology, of the Felow of Chinese Medical Association of Minorities. He is also invited professor of Pharmacology at the Medical University of Xinjiang (China) and the Institute of traditional Uyghur Medicine.

He has co-authored over 300 papers in peer-reviewed journals.

Considerations on ENCePP and best pharmacoepidemiology methods for PASS
Monday, 17 October, 17:05 - 17:30

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Dr. Holger Maria Rohde

Director, Strategy Implementation Lead, Merck Serono | Strategy and Business Operations Global R&D

Dr. Holger Maria Rohde, MBA studied Human Biology at Philipps-University Marburg and Monash University Melbourne and Health Economy at the European Business School Wiesbaden. Starting with the pharmaceutical industry in 2000, he worked in preclinical and clinical oncology research for Boehringer-Ingelheim and Novartis. Later he engaged with PharmaLex GmbH, Mannheim, one of the leading service providers for development consulting and regulatory affairs in Germany. Here he was heading the department „Preclinical and Medical Affairs & Market Access“for several years and was responsible for consulting and successful delivery of all preclinical, clinical and pharmaeconomic service projects with his team for numerous well-known pharmaceutical client companies. After that, he worked in Medical Affairs for Teva Speciality Medicines and was responsible for peri- and postapproval medical operations. After that he started as Director Strategy and Business Operations for Merck KGaA and later Director Regulatory Project Management, where he coordinates the implementation of strategic change initiatives in the R&D Department.

Transparency in Clinical Research of Medicinal Products: Pre and Post Marketing Authorisation
Monday, 17 October, 14:40 - 15:05

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Dr Yvonne Rollinger

Managing Director, OmniComm Europe GmbH, Bonn, Germany

Dr. Rollinger is Managing Director of OmniComm Europe, located in Bonn, Germany. Dr. Rollinger is overseeing all business activities of this entity. Before joining OmniComm Dr. Rollinger was Director Clinical Services and Senior Consultant at DATATRAK, leading the team of project managers and data managers and being responsible for EDC change management and workflow consulting for clients. Prior to that position Dr. Rollinger served as Project Manager, CRA and Sales Representative at Medifacts International Medical Consultants, Padcom Clinical Research, Dolorgiet Pharmaceuticals and Spitzner Pharmaceuticals.

Dr. Rollinger received a PhD from Rheinische Friedrich-Wilhelms-Universität Bonn in Biology and Biochemistry. She has more than 20 years of experience in the pharmaceutical industry with a focus on clinical trial management and EDC.

Risk-based Monitoring, trends in the model implementation
Tuesday, 18 October, 9:50 - 10:15

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Ivo Schauwecker

Clinical Studies Manager, AO Foundation, AOCID, Switzerland

Ivo Schauwecker holds a degree in biochemistry and a diploma in Pharmaceutical Medicine (EUCOR/ECPM).  He has over 20 years of operational experience in international clinical research in the pharmaceutical, medical device and CRO industry. He started his career in clinical research with the CRO Pharma Focus Consultants (now Clinipace) in Switzerland. After that he became co-funder of the CRO Appletree in Switzerland and was serving the company for 6 years. He joined the clinical research institute AOCID of the AO Foundation 6 years ago. At the AOCID he is member of the managing team and is responsible for various fields of activities. His responsibilities are client relations and business development as well as vendor management. He is also the lead figure in the AO Clinical Study Center program to establish and educate a global network of orthopedic and trauma clinics qualified to conduct clinical research and he acts as faculty in various courses in the field of GCP offered by AOCID. He initiated and consults on the new AO initiative to establish the Medical Device World – a conference bringing together various stakeholders in the medical device field. He also serves as board member of the Swiss Association of Pharmaceutical Professionals (SwAPP) for more than 12 years.

Challenges of Clinical Research in the Surgical Field - How to Generate Clinical Evidence?
Tuesday, 18 October, 11:40 - 12:05

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Gabriele Schwarz, PharmD

Head of GCP Inspectorate, German Federal Institute for Drugs and Medical Devices

Gabriele Schwarz is head of the GCP Inspectorate at the German Federal Institute for Drugs and Medical Devices (BfArM). Her responsibilities entail the planning, coordination, and execution of BfArM’s GCP inspection activities, primarily in relation to European marketing authorization procedures for medicinal products.

Since 2001, she is an appointed member of the GCP Inspectors Working Group (GCP IWG), hosted and chaired by the EMA in London, providing regulatory expert advice and support on matters related to GCP and GCP inspections. She is involved in several GCP IWG subgroups dealing with topics such as Risk-Based Quality Management of Clinical Trials, Risk-Based Monitoring, (electronic) Trial Master Files and the implementation of electronic tools and media for capturing e.g. source data (eSource) and Informed Consent (eIC). She is co-author of several European Guidance Documents and Reflection Papers.

Since 2006 she is involved in the ADAMON research project that deals with the scientific evaluation of risk-adapted monitoring strategies.

In 2011/12 she contributed to the development of the OECD Recommendation on the Governance of Clinical Trials.

Since 2014 she represents the EU Member States in the ICH E6 Expert Working Group.

She is author and co-author of several publications on e.g. currents trends in GCP, GCP inspections, monitoring, authorization procedures for clinical trials and GCP-compliant digital archiving of paper-based patient records of clinical trial subjects.

ICH-GCP Addendum
Monday, 17 October, 15:35 - 16:20

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Any pitfalls in RBM implementation? The perspective of the Regulators
Tuesday, 18 October, 9:25 - 9:50

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Mark Turner

Chair, European Network of Paediatric Research at the European Medicines
Agency & Senior Lecturer in Neonatology, University of Liverpool, UK

Mark Turner BSc, MBChB, DRCOG, MRCP, MRCPCH, PhD is a Neonatologist at Liverpool Women’s Hospital and the University of Liverpool. He aims to improve the access of newborn babies and children to high quality medicines. He has studied the dosing, safety and efficacy of 12 medicines in neonates in the past 5 years. He led the European Study of Neonatal Excipient Exposure (ESNEE) which conducted ground-breaking research about the exposure of neonates to excipients using PK and epidemiological methods. He is clinical lead on studies of paracetamol and midazolam using microdosing methodologies. He is currently working on manipulations of medicines, the avoidability of adverse drug reactions and the pharmacoeconomics of age-appropriate formulations.

He believes that research infrastructure is key to improving the quality of information about medicines and he works to develop paediatric medicines research infrastructure as Associate Director for International Liaison at the English National Institute for Health Research Clinical Research Network’s Children Theme (NIHR CRN:C), as Chair of the European Network for Paediatric Research at the European Medicines Agency (EnprEMA) and as co-Coordinator of the European Commission-funded Network of Excellence, Global Research in Paediatrics (GRiP).

The role of paediatric Networks and benefits in paediatric research
Tuesday, 18 October, 11:40 - 12:05

Jorunn Tverland

Clinical Trial Manager, Dako, Agilent Technologies, Denmark

Jorunn Tverland has 11 years of work experience with clinical trial operations, both pharmaceutical and medical device trails. Since June this year Jorunn holds the position as Senior Clinical Trail Manager at Dako, an Agilent Technologies company where she conducts clinical trials within Invitro cancer diagnostics.

Jorunn earned her Bachelor Degree in Nursing in 1999 and a few days after her graduation she travelled to Botswana where she in collaboration with UNICEF, UNHCR and Botswana Family Welfare opened and ran a youth clinic offering sexual and reproductive health services with the aim to stop the spread of HIV/AIDS. Jorunn continued to work within the field of HIV/AIDS with Copenhagen HIV Programme for 8 years where she held the positions as Clinical Monitor, Clinical Trial Coordinator and Clinical Trial Manager and participated in monitoring, planning and the conduction of large international clinical trials with HIV treatments. Prior to Jorunn´s move to Dako, she worked as Manager Monitoring with Cook Medical for three years where she managed the company´s European medical device trial activities.

Specific considerations of in vitro diagnostics
Tuesday, 18 October, 12:05 - 12:30

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Vincent Varlet, Dr., MD, MBA, INSEAD

Executive Consultant www.varlet.paris – business transformation for healthcare companies

Dr Vincent VARLET was born in 1964 and earned his medical degree at Faculté de Médecine de Paris. He received also his master degree in marketing from Université Pierre et Marie Curie in 1992 and a Global Certification at INSEAD in 2015.
After spending several years in Servier’s laboratories in different positions (R&D, commercial, marketing), he joined the pharma company IPSEN as manager of the Business Franchise for a large range of products. During the same period Dr Varlet Founded the department of New technologies and Communication.

In parallel, he maintained his medical activities in Emergency Room and SAMU’s ambulance during 12 years.

In 2001, Vincent Varlet joined the executive committee of Wyeth Pharmaceuticals France as e-Business director, in charge of creating a new department dedicated to e-Strategies regarding intranet, internet, e-learning, e-detailing, e-CRM and all other e-initiatives like mobile or social media activities, integrated in business operation and communication.

In 2008 Dr Varlet became the Communication Director in addition of his previous responsibilities, in a special commitment to prepare the merger with Pfizer.

In 2010 and for 5 years, Vincent  joined the French Novartis executive committee (including all Divisons – Pharma, Sandoz, Vaccines, OTC, Onco, Animal Health) as the Executive Director for Marketing Services & Communication, driving the synergy, the Customer Demand management and the deliverables of several departments dedicated to the Business objectives: Communication (internal, external, patient groups, corporate Cross-Division), Advertising, Promotional material & logistics, Digital operations, Training (Field Forces & competencies), transversal customers (pharmacists, nurses), Congresses & Events, Professional relationships, Reps BackOffice and all outsourced suppliers (Specialties, Primary Care and Oncology), Shared tools for an ongoing reassessment of business models, including governance, productivity, customer differentiation, visibility and optimization.

In the same year he decided to revamp the Digital Healthcare think-tank « LeLabEsanté » as the president including patient groups, HCP, pharma industries, star-ups, IOT and developers.

Dr Varlet is now focused on business transformation for healthcare companies as an executive consultant varlet.paris

From pharma to health Laboratories: how the Internet of Things is changing the way of delivering treatments
Monday, 17 October, 16:40 - 16:55

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Alan Yeomans

Quality Manager, PCG Solution; representing EUCROF WG on NT

Alan Yeomans has been Quality Manager for Pharma Consulting Group since late 2008, where he is responsible for Quality Assurance of both the EDC vendor business and the CRO business that is part of the group.

Within the Clinical Research industry Alan has earlier worked as CTO for a Swedish CRO (CDC) and as CTO and QM for an international ePRO provider (Clinitrac).

Alan has worked with electronic source data in medical research since 2000.

He has worked in the following International Projects aimed at the reuse of EHR data for clinical research:

EHRCR Project – EU Team Leader
EHR4CR Project – Member of User Scenario Task Team
eClinical Forum eSource Task Group – Technical Stream Team Leader

Alan has worked with the development of computerised systems for over 30 years as hardware designer, programmer, system architect, project manager and in a number of management roles including CTO and QM.
Alan graduated with a Bachelor of Engineering (Electronics) from the University of Western Australia in 1980, and studied Control Systems at the Imperial College (London) in 1983.

Alan is a member of RQA (the Research Quality Association) and eCF (the eClinical Forum).

Cloud services, Internet of Things, Independant Third Party: new opportunities for CROs ?
Monday, 17 October, 16:55 - 17:10

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Eng. Gianluca Zia

CEO, Caretek s.r.l., Torino, Italy

Gianluca Zia, is President of Caretek LLC, a SME based in Turin, Italy, that develops Information&Communication Technologies (ICT) systems and connected devices for Health applications. 

Specific to Active&Healthy Ageing

Since 2013 -:  WP6 Leader of the IMI “SPRINTT” Consortium, a collaborative project on Physical Frailty & Sarcopenia that will follow-up at least 1500 over 70 years old participants for two years, with paper-less clinical data collection, remote data monitoring and physical activity measuring via a connected device. SPRINTT clinical trial is conducted in 7 EU countries.

2011-, contributing to the European Commission public consultation and the subsequent Active&Healthy Ageing Pilot Innovation Program, with a focus on adapted homes and independent living for elderly people. 

Gianluca, is a civil engineer, holding a master's degree in Structural Civil Engineering from “La Sapienza” University, in Rome, Italy. 

He has extensive knowledge and skills in the design of buildings, home automation and applied ICT. He has lead working teams on large projects, and more than 30 year experience on computer science applied to civil engineering, and corporate information systems. 

After graduating, he worked for a Hewlett Packard partner developing connections for medical devices with the previous standards (GP-IB, IEEE488, RS232). More recently he has developed a specific software for nonlinear rail-structure interaction of bridges.
He has designed and coordinated the implementation of 24/7 service for Mondonet (for Hewlett Packard in Telemedia International-TelecomItalia) a global worldwide network which implements point-to-point communication services on frame relays between the USA, Europe and the Far East.
He has directed and managed ICT projects and services for governmental and private sector enterprises i.e.: Poste Italiane, BNL (currently BNP Paribas), INPS (the Italian pension government system), ERP and RAI (the Italian national radio-television broadcasting company).
He previously served as managing director of the Italian branch of Nemetschek AG, a German company that develops software for architectural and civil engineering.

Innovative ICT architecture with modular integrated component for new study profile: SPRINTT study ICT structure
Monday, 17 October, 17:25 - 17:40

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