Venue
Congress Center Basel
Congress Center Basel, Messepl. 21, 4058 Basel, Switzerland

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Qwoted is a free expert network: we help reporters connect with experts & we help those same experts build relationships with top reporters.

Event Date Wed Mar 22 CET - Fri Mar 24 CET (over 1 year ago)
In your timezone (EST): Tue Mar 21 7:00pm - Thu Mar 23 7:00pm
Location Congress Center Basel
Messepl. 21, 4058 Basel, Switzerland
Region EMEA
Details

DIA Europe 2023 is designed to drive insights into action by connecting key policy discussions to real-world knowledge that you need for your everyday job. Your participation will accelerate your growth and your organization's performance in the drug development ecosystem.

Gathering innovative thought leaders from the entire life science landscape, DIA always has the aspiration to be ahead of current developments, reflected by 4 new content tracks in 2023:

• Artificial Intelligence and Data Science
• EU Health Policy and Regulatory Strategy
• Medical Devices and Combination Products
• Professional Development

Why should you attend? 

• NETWORKING - Reunite with your colleagues and expand your network!
• STATE OF ART CONTENT - 100+ session filled with conversations on today's healthcare priorities.
• MULTI-STAKEHOLDER MEETING - Countless international key stakeholders, including speakers from the Regulatory Authorities (EMA, FDA, MEB, MHRA), the European Commission, Academia, HTAs, Patient Organizations and more.

Speakers

2023 Speakers

Virginia Acha, PhD, MSc
AVP, Global Regulatory Policy, Merck Sharp & Dohme LLC, United Kingdom

Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

Sabine Atzor, MPharm, RPh
Head of EU Regulatory Policies, F. Hoffmann-La Roche Ltd, Switzerland

Alison Bond, PhD
Director, Global Regulatory and R&D Policy, Amgen, United Kingdom

Thomas Brookland, MSc
EU Data Policy Lead, F. Hoffmann-La Roche Ltd., Switzerland

Ursula Busse, PhD, MBA
Head of Regulatory Affairs, Tigen Pharma SA, Switzerland

Claudia Cabrera
Senior Director Epidemiology & Evidence Excellence, AstraZeneca AB, Adj Researcher Karolinska Institute, Dept Epidemiology and Biostatistics, Sweden

Melanie Carr
Head of Stakeholders and Communication Division, European Medicines Agency, Netherlands

Michelle Crouthamel, PhD
Head, Digital Science, AbbVie, United States

Juan Garcia-Burgos, MD, PhD
Head of Public and Stakeholders Engagement, European Medicines Agency, Netherlands

Markus Goese
Head EU CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland

Fengyun(Vicky) Han
Senior Director, Head of Regulatory Policy for Asia Pacific, Johnson & Johnson Pte. Ltd., Singapore

Shahid Hanif, PhD, MSc
Managing Director, GetReal Institute, Canada

Helena Harnik
Executive Director, The Synergist ASBL, France

Inka Heikkinen, MBA, MS, MSc
Director, Global Regulatory Policy, MSD, Denmark

Anne-Sophie Henry-Eude, PharmD
Head of Access to Documents Department, European Medicines Agency, Netherlands

Esteban Herrero-Martinez, PhD
Director Regulatory Policy and Intelligence, AbbVie, United Kingdom

Milou Hogervorst, PharmD, MSc
PhD Candidate, Utrecht University, Netherlands

Tony Humphreys, MPharm
Head of the Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands

Judith Catherine Macdonald
Senior Director, Global Policy Development, Pfizer, United Kingdom

Marina Alexandra Malikova, PhD, MBA, MS, RAC
Executive Director, Translational Research, Assistant Professor of Surgery, Boston University School of Medicine, United States

Michael Meighu, PhD, MS
Director of Consulting - Expert, Artificial Intelligence, CGI, United States

Anne Moen, PhD, MSc, RN
Professor, Faculty of Medicine, Coordinator, Gravitate-Health, University of Oslo, Norway

Mireille Muller, DrSc, PhD, MSc
Regulatory Policy & Intelligence Director, Novartis Pharma AG, Switzerland

Koen Nauwelaerts, PharmD, PhD, MBA
Regulatory Policy and Innovation Lead, Bayer AG, Belgium

Francesco Pignatti, MD
Head of Oncology and Hematology, European Medicines Agency, Netherlands

Matt Popkin, PhD
Senior Director, CMC Excellence, Global Regulatory Affairs, GlaxoSmithKline, United Kingdom

Claudia Popp
Head EU Regulatory Science and EMA Liaison, F. Hoffmann-La Roche Ltd / EFPIA , Switzerland

Valerie Powell, MS
Chief Patient Officer, CorEvitas and EVP, Patient Experience, Corevitas, LLC, United States

Lars Rugholm, MSc
Senior Adviser, Danish Medicines Agency (DKMA), Denmark

Tina Wang, MSc
Senior Manager, HTA programme and strategic partnership, CIRS- Centre For Innovation In Regulatory Science, United Kingdom

Amira Deia Younes
Associate Director, Reg Policy& Intelligence MEA, Russia, CEE & EFPIA MERN Chair, AbbVie, United Arab Emirates

Blythe Adamson, PhD, MPH
Principal Scientist, Flatiron Health, United States

Susana Almeida, PhD
Clinical Development and Safety Director, Medicines for Europe, Belgium

Billy Amzal, PhD, MPA, MSc
CEO, Quinten Health, France

Susanne Ausborn, PhD
Global Head International Regulatory Policy, Roche, Switzerland

Samvel Azatyan, MD, PhD
Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland

Gesine Bejeuhr, PharmD
Pediatric Regulatory Leader, Bayer AG, Germany

Susan Bhatti, PhD
Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs, Merck Healthcare, Netherlands

Agnete Louise Bjerregaard Nielsen
Principal Advisory Consultant, NNIT, Denmark

Sérgio Cavalheiro Filho, MPharm
Manager, Regulatory Affairs, IFPMA, Switzerland

Alison Cave, PhD
Chief Safety Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Evjatar Cohen
Global Head of Life Sciences Industry Solutions, ServiceNow, Switzerland

Solange Corriol-Rohou, DrMed, MD, PhD
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca, France

Helena Corte-Real Correia, PhD
Global Head of Regulatory Operations, F. Hoffmann-La Roche Ltd, Switzerland

Annick De Bruin, MBA
Senior Director, Research Services, CISCRP, United States

Jean-Christophe Delumeau, MD, PhD
Senior Expert, Institute of Pharmacovigilance, Czech Republic

Laurent Desqueper
IDMP Business Lead, MSD Europe, Belgium

Douglas Drake, MBA
Senior Director, Client Solutions, Clinerion Ltd, Switzerland

Maria Dutarte
Executive Director, European Patients Academy (EUPATI), Netherlands

Jelena Duza
Junior Public Affairs Manager, Novartis, Switzerland

Theo Favard
Vice President of External Relations, European Pharmaceutical Students' Association (EPSA), Belgium

Mick Foy
Deputy Director of Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jan Geissler, MBA
Managing Director, Patvocates, Germany

Andrew Gray
Director, Global Regulatory and R&D Policy, Amgen, United Kingdom

Paolo Guerra
Medtech Director and Principle Consultant, ProductLife Group, France

Sabine Haubenreisser, PhD, MSc
Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands

Claudia Hey, DrSc, PharmD
Senior Director, Head Europe Global Regulatory & Scientific Policy, Merck Healthcare KGaA, Germany

Kenneth Hu, PharmD, MBA
Senior Manager (US Reg Lead), Global Regulatory Strategy & Policy, Oncology, Bristol Myers Squibb, United States

Angelika Joos, MPharm
Executive Director, Global Regulatory Policy, Merck Sharp & Dohme (Europe) Inc., Belgium

Katrin Manlik
Senior Lead Data Scientist, Bayer AG, Pharmaceuticals, Germany

Mary Lynn Mercado, PhD
Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States

Alexandra Moens
Director of Product Marketing, H1, United States

Rodrigo Palacios, MBA
Regulatory Policy Lead, F. Hoffmann-La Roche, Switzerland

Nikos Paragios
President & Chief Executive Officer, TheraPanacea, France

Marjon Pasmooij, PhD
Head Science Department, MEB, Netherlands

Mark Perrott, PhD
Managing Partner, Axian Consulting Limited, United Kingdom

Marc Philipp
Partner & Managing Director, Kearney, Germany

Elena Popa, MPharm
Regulatory Policy & Innovation Lead, Bayer, Switzerland

Smita Robinson
Director - Regulatory Labelling, Pfizer, United Kingdom

Stephan Roenninger, DrSc
Director, Quality External Affairs, Amgen, Switzerland

Sharmila Sabaratnam
Senior Director, Vault Safety Strategy, EU, Veeva Systems, United Kingdom

Junko Sato, PhD
Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Katherine Tyner, PhD
FDA Liaison to the EMA, Office of Global Policy and Strategy, OC, FDA, United States

Adrian van den Hoven
Director General, Medicines for Europe, Belgium

Sarah Vaughan
Head of Vigilance Development, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Emmanuel Walckenaer
CEO, Yseop, United States

Kathy Wang, MSc, RAC
Director, Devices & Digital Therapeutics, CMC Regulatory Affairs, AstraZeneca, Sweden

Anne Willemsen, MSc
Senior Project Manager, Joint Production Co-Lead Partner - Pharmaceuticals, ZIN - National Health Care Institute, Netherlands

Youness Ameur
Regulatory Associate Program Director, Roche, Switzerland

Priya Bahri, PhD, RPh
Lead Pharmacovigilance and Risk Management Guidance and Policy, European Medicines Agency, Netherlands

Anne Bourrelly, MBA, MSc
GTL Regulatory Information Management, F Hofmann-La Roche Ltd, Switzerland

Patrick Brady, PharmD
Head Regulatory Policy & Intelligence, Bayer AG / Research & Development, Pharmaceuticals, Germany

Karl Broich, DrMed
President, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Magda Chlebus, MA
Executive Director, Science Policy & Regulatory Affairs, EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

Vicki Edwards, RPh
Vice President, Pharmacovigilance Excellence and International QPPV, AbbVie, United Kingdom

Claudia Ferreira
Scientific Programmes Specialist, DIA, Switzerland

Zaide Frias, PharmD
Head of Digital Business Transformation Task Force, European Medicines Agency, Netherlands

David Haerry
Co-Chair Advisory Committee, EUPATI Foundation,European AIDS Treatment Group, Belgium

Martin Harvey Allchurch, LLM
Head of International Affairs, European Medicines Agency, Netherlands

Ralf Herold, MD, PhD
Senior Scientific Officer, Regulatory Science and Innovation Force, European Medicines Agency, Netherlands

Anette Hjelmsmark, MS
Senior Regulatory Intelligence Manager, Novo Nordisk A/S, Denmark

Ian Hudson
Senior Advisor, Integrated Development, Bill and Melinda Gates Foundation, United States

Christophe Lahorte
Head of National Innovation Office and Scientific-Technical Advice Unit, Federal Agency for Medicines and Health Products, Belgium

Fadila Lakkis
Regulatory Affairs, Intelligence & Communications Manager, Gulf, GSK, United Arab Emirates

Susanne Norskov
Vice President, Global Clinical Compliance, Novo Nordisk A/S, Denmark

Chelsea O'Connell, MS, RAC
Director, Global Regulatory and R&D Policy, Amgen, United States

Magdalini Papadaki, PhD, MBA, MSc
Director, Regulatory Affairs International, MSD, United Kingdom

Leonardo Semprun, RPh
Global Regulatory Policy Lead-LatAm, MSD, Panama

Nick Sykes, MS
Senior Director, Global Regulatory Affairs, Pfizer Inc, United Kingdom

Francisca Vaz
Senior Specialist, QA Release Coordinator, Moderna, Switzerland

Nadege Le Roux, DrPH, PhD
Regulatory Policy Senior Director, Bristol Myers Squibb, Switzerland

Nevena Miletic
Regulatory Policy Lead, Roche, Switzerland

Hubert Leufkens
Professor, Pharmaceutical Policy and Regulatory Science, Utrecht University, Netherlands

Cedric Berger
Head of Knowledge Extraction and Integration, F. Hoffmann-La Roche, Switzerland

Claus Bolte, DrMed, MBA
Head of Authorisation, Swissmedic, Switzerland

Emer Cooke, MBA, MSc
Executive Director, Chair, ICMRA, European Medicines Agency, Netherlands

Arie Gafson
Head of Personalized Medicine R&D for Digital Health, Biogen, Switzerland

Grigorios Agkyralidis, MSc
Head of Regulatory Affairs, BOEHRINGER INGELHEIM HELLAS Single Member SA, Greece

Scott Askin, MSc
Global Program Regulatory Director, Novartis Pharma AG, Switzerland

Cristina Baccarelli, MSc
GMP Inspector, European Directorate for the Quality of Medicines and Healthcare (EDQM), France

Liese Barbier, PharmD, MS
Postdoctoral researcher, KU Leuven, Belgium

Henrik Bjorklund
Associate Professor, Department of Computing Science, Umea University, Sweden

Christelle Bouygues
Acting Head of Regulatory Affairs, Office Scientific and Regulatory Management, European Medicines Agency, Netherlands

Gabriele Breda
Research and Innovation Director, ProductLife Group, France

David Brown, MSc
Head of Statistics Team, Healthcare, Quality & Access, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Lisa Charlton
Senior Director, Product Development, eCO, Science 37, United States

Fabio D’Atri
Policy Officer, Deputy Head of Unit, Unit B5 Directorate General for Health and Food Safey, European Commission, Belgium

Claudia Dollins, PhD, RAC
Head, Global Regulatory Affairs, Precision Medicine and Digital Health, Bristol Myers Squibb, United States

Katherine Donegan
Pharmacoepidemiology, Research & Intelligence Unit Manager, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Marwan Fathallah
President & Global Chief Executive, DIA, United States

Giovanna Ferrari, PhD
Regional Labelling Lead, Senior Director, Pfizer Ltd, United Kingdom

Barbara Freischem, DVM
Head of Veterinary Surveillance and Regulatory Support Department, European Medicines Agency, Netherlands

Yasuhiro Fujiwara, MD, PhD
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

James Gallagher
Team Leader, Janssen Clinical Innovation, Switzerland

Kenneth Getz, MBA
Executive Director/Professor, Tufts CSDD; Founder/Board Chair, CISCRP, Tufts University School of Medicine, United States

James Griffiths
Team Leader for Integration Services, Veeva Systems, United Kingdom

Hilmar Hamann, PhD
Head of Information Management Division, European Medicines Agency, Netherlands

Niklas Hedberg, MPharm
Chair EUnetHTA Executive Board, Dental and Pharmaceutical Benefits Agency, TLV, Sweden

Nasir Hussain
Associate Director of Regulatory Intelligence, Gilead Sciences, United Kingdom

Lars Hyveled-Nielsen, MPharm
Regulatory Project Director, Zealand Pharma, Denmark

Veronika Jekerle, PhD, RPh
Head of Pharmaceutical Quality, European Medicines Agency, Netherlands

Evangelos Kotzagiorgis, MPharm, MS
Scientific Administrator, Quality of Medicines, Human Medicines Evaluation Div, European Medicines Agency, Netherlands

Olivier Luttringer
Global Head, Advanced Quantitative Evidence, Global Medical Affairs, Novartis, Switzerland

Neil McAuslane, PhD, MSc
Director, Centre for Innovation in Regulatory Science (CIRS), United Kingdom

Vishal Mehta
Head of Life Sciences Go-to-Market EMEA, ServiceNow

Hudu Mogtari
Executive Director, African Centre For Health Regulatory Consult, Ghana

Raul Mora, MSc
Senior Strategic Operational Intelligence Head, Hoffmann-La Roche, Switzerland

Ritu Nalubola, PhD
Director, FDA Europe Office, FDA, Belgium

Handan Öztunca
Head of Marketing Authorization Department, Turkish Medicines and Medical Devices Agency (TITCK), Turkey

Lykke Pedersen, PhD
Head of RNA THerapeutics, Abzu, Denmark

Stefan Peev
PRINCIPAL ADVISORY CONSULTANT, NNIT, Switzerland

Ana Maria Rodriguez Leboeuf Rodriguez, PhD, MPH, MSc
Director, Preference Practice Lead, Patient Centered Solutions, IQVIA, Spain

Joseph M Rymsza
Vice President, Global Safety, Regulatory and Quality Technology Solutions, IQVIA, United States

Khushboo Sharma, MBA
Chief Regulatory Innovation Officer, Accumulus Synergy, United States

Hiiti Sillo
Unit Head, Regulation and Safety, WHO, Switzerland

Andrew Thomson, PhD, MA, MS
Statistician, Methodology Taskforce, European Medicines Agency, Netherlands

Christine van Hattem, MSc
PhD candidate, Utrecht University, Netherlands

Effy Vayena
Deputy head of Institute of Translational Medicine, Swiss Federal Institute of Technology, Switzerland

Wija Oortwijn, PhD, MSc
Senior Scientific Researcher, Department for Health Evidence, Radboud University Medical Centre, Netherlands

Dimitrios Athanasiou, MBA
Patient Advocate, WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece

Michael Berntgen, PhD
Head of Scientific Evidence Generation, European Medicines Agency, Netherlands

Stephen Duffield
Senior Analyst, National Institute for Health and Care Excellence (NICE), United Kingdom

Aleksandra Opalska
Policy Officer, European Commission - DG SANTE, Belgium

Mark Turner, MD, PhD, MRCP, FFPM
Professor of Neonatology and Research Delivery, University of Liverpool, United Kingdom

Aris Tzavaras
Head of Notified Body Artificial Intelligence, BSI Group, Netherlands

Padraic Ward
Head of Roche Pharma International, Roche, Switzerland

Lauren Abrey
CMO, inCephalo, Switzerland

Hiroyuki Arai, PhD
Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Stephanie Croft
Technical Officer, World Health Organization, Switzerland

Joan D'souza
Regulatory Intelligent Expert, Institute of Pharmacovigilance, Switzerland

Kelly M. Dumais, PhD
Principal Scientific Advisor, Clario, United States

Helen Kathryn Edelberg, MD, MPH, FACP
Deputy Office Director for Safety, Office of New Drugs, FDA, United States

Inci Ergönül
Head of Clinical Trials Department, Turkish Medicines and Medical Devices Agency (TITCK), Turkey

Sini Eskola, MPharm, MS, MSc
Director Regulatory Affairs, EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

Melissa Estevez, MS
Senior Quantitative Scientist, Flatiron Health, United States

Markets Supply Lead (MCAM)
AstraZeneca; Chair of the Supply Chain WG at EFPIA, Italy

Daniel Fernandez
Data Scientist, AstraZeneca, Netherlands

Anthony Gill, DrMed
Principal Medical Adviser, TGA, Australia

Flora Giorgio, MPharm
Deputy Head of Unit Medical Devices, DG SANTE – Medical Products and Innovation, European Commission, Belgium

Marco Greco, PhD
President, European Patients' Forum, Belgium

Sibel D. Guerler, MSc
Head, Innovation, Partnerships & Process Optimization, WorldWide Patient Safety, Bristol Myers Squibb, Switzerland

Adrian Hernandez, MD, MHS
Professor of Medicine; Executive Director, Duke Clinical Research Institute (DCRI), United States

Rhydian Howells
Senior Manager, KPMG, United Kingdom

Tahira Jan
Vigilance Development Improvements Lead, MHRA, United Kingdom

Rosanne Janssens, DrSc, MSc
Postdoctoral Researcher, Patient Preference Studies, KU Leuven, Belgium

Alireza Khadem Broojerdia
Scientist, Regulatory Systems Strengthening (RSS), WHO, Switzerland

Jesper Kjær, MS
Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre, Danish Medicines Agency (DKMA), Denmark

Dominique Lagrave, PharmD
VP of Regulatory Innovation, Accumulus Synergy, United States

Andrew Lennard, PhD, MS
Regulatory Affairs CMC, Amgen, United Kingdom

Declan Noone
PRAC Patient Representative, President of the European Haemophilia Consortium (EHC), Ireland

Cécile Mathilde Ollivier, MS
Managing Director Europe, Critical Path Institute, Netherlands

Zack Pemberton-Whiteley, LLM
Chief Executive Officer, Leukaemia Care, United Kingdom

Douwe Postmus, PhD, MSc
Assistant Professor, Medical Statistics & Decision Making, Dept of Epidemiology, University Medical Center Groningen, Netherlands

Karen Quigley
Clinical Data Publication Manager, European Medicines Agency, Netherlands

Leyla Rahjou-Esfandiary, PharmD
Lead CSO, Office of Compliance, CDER, FDA, United States

Kirsty Reid
Director Science Policy, EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

Elizabeth Scanlan, PhD, MSc
Scientific Communication Officer, European Medicines Agency, Netherlands

Gabriele Schwarz, MPharm
Head, GCP Inspectorate, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Jeffrey Scott, JD
Lead Compliance Counsel, Digital, Reporting, and Aanlytics, Pfizer Inc, United States

Laura Squire
Chief Healthcare Quality & Access Officer, MHRA, United Kingdom

Lisa Stagi, MSc
Patient Safety County Cluster Lead Europe, Roche Spa, Italy

Valentina Strammiello, MA
Head of Programmes, European Patients' Forum, Belgium

Jonathan Sutch, PhD
Principal Medicinal Technical Specialist, BSI Group, United Kingdom

Marlene Thomas
Senior International Scientific Director, F. Hoffmann-La Roche, Switzerland

Cynthia L. Verst, PharmD, MS
President, Design and Delivery Innovation, Research & Development Solutions, IQVIA, United States

Stephanie Von Klot, PhD, MPH, RPh
Lead Safety Data Scientist, Boehringer Ingelheim International Gmbh, Germany

Baoshu Wen
Center for Drug Evaluation, CFDA, China

Juergen Wieland
Global Drug Development Environmental Sustainability Lead, Novartis Pharma AG, Switzerland

Sacha Wissink, PhD
Executive Director, Regulatory Affairs Europe, MSD Netherlands, Netherlands

Alessandra Zago Jorgetto, MBA
Regional Patient Safety Head - Emerging Market, Boehringer Ingelheim, Germany

Larisa Aragon Castro
Executive Board Member, EUPATI Switzerland, Switzerland

Leonardo Dutra Rosa
Head of the International Affairs Office, ANVISA, Brazil

Lorenzo Guizzaro
Scientific Officer, European Medicines Agency, Netherlands

Chitkala Kalidas
VP and Head Oncology Regulatory Affairs, Bayer, United States

Georg Neuwirther, MS, MSc
IT Director, Austrian Medicines & Medical Devices Agency (AGES), Austria

Linda J. Scarazzini, MD, RPh
Vice President, Pharmacovigilance and Patient Safety, AbbVie, United States

Alex Simpson
Access RWE Lead, Hoffmann-La Roche, Switzerland

Álmath Máire Spooner, PhD, RPh
Director of Regulatory Policy and Intelligence, AbbVie, Ireland

Aimad Torqui
Head of Division Medicines Evaluation Board, MEB, Netherlands

Rick Vreman
Patient Access Manager, Roche Netherlands B.V., Netherlands

Michael Zaiac
Head of Medical Affairs Oncology Region Europe, Novartis, Switzerland

Fiona Adshead, DrMed, DrPH, MD, MPH, MSc, FRCP
Chair of the Sustainable Healthcare Coalition, Sustainable Healthcare Coalition, United Kingdom

Monique Al
Team Coordinator National Clinical Trial Office, Central Committee on Research Involving Human Subjects (CCMO), Netherlands

Bandar Al Hammad
Chief Pharmacist, Regulatory Affairs Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia

Rinol Alaj, MBA
Director, Clinical Outcomes - Assessments and Innovation, Regeneron Pharmaceuticals, United States

Jill Baehring
Associate Director, IQVIA, United States

Marc Bailey
Chief Science and Innovation Officer, MHRA, United Kingdom

Nihan Burul Bozkurt, PhD
Health Policies Director, AIFD, Turkey

Lisbeth Bregnhoj, PhD, MPharm
Medicines Inspector, GCP, Danish Medicines Agency (DKMA), Denmark

Jasper-Hugo Brouwers
Head of corporate affairs, stakeholders engagement and medicines use, MEB, Netherlands

Cristiana Campa, PhD
Technical R&D Advisor and Senior Fellow, GSK Vaccines, Italy

Catherine Chronaki, MSc, PMP
Secretary General, HL7 Europe Foundation, Belgium

Corneel Coens, MSc
Lead Statistician, EORTC, Belgium

Isabelle Colmagne-Poulard, PharmD, MBA, MSc
Head, International Global Regulatory Affairs & Scientific Policy, Merck KGaA, Switzerland

Brendan Cuddy
Chairman, GMDP Inspectors Working Group; Lead Scientific Officer, European Medicines Agency, Netherlands

Kevin Cunningham
Scientific Officer, European Medicines Agency, Netherlands

Michael Drues, PhD
Founder and President, Vascular Sciences, United States

Maria I. Florez, MA
Research Consultant, Tufts Center For the Study of Drug Development, United States

Thierry Gastineau, PharmD
Global Head Quality Innovation, Culture & Engagement, Sanofi, France

Louise Gill, PhD
Vice President Regulatory Policy, GSK, United Kingdom

Ali Hansford, PhD, MSc
Head of Regulatory Strategy Policy, ABPI, United Kingdom

Jane Howard-Jones
Senior Director Regulatory Affairs, Gilead Sciences, United Kingdom

Martin Huber, MPH, MPharm
Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Brad Jordan, PhD
Senior Director, Head of Regulatory Affairs Policy, Flatiron Health, United States

Daisuke Koga
Division Director, Division of Planning and Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Ye-eun Lee
Assistant Director, Department of Novel Product Approval, Ministry of Food and Drug Safety(MFDS), Korea

Claudia Louati, MA, MSc
Policy Advisor, FDA Europe Office, U.S. Food and Drug Administration, Belgium

Laurent Mallet, PhD
Head of Biological Standardisation, OMCL Network and HealthCare Department, European Directorate for the Quality of Medicines and Healthcare (EDQM), France

Chris McCurdy
Chief Architect for Healthcare & Life Sciences, Amazon Web Services, Netherlands

Heike Moehlig-Zuttermeister, DrSc
Head of Business Line IVD, TUV SUD, Germany

Deana Mohr
CEO & Co-Founder, Muvon Therapeutics, Switzerland

Vasee Moorthy
Science Division, World Health Organization (WHO), Switzerland

Remco Munnik
Associate Director, Iperion, Netherlands

Irene Norstedt
Director - People Directorate, DG Research and Innovation, European Commission, Belgium

Christopher Oduor Okonji
African Union Commission, Ethiopia

Chi Pakarinen, MA
Programme Lead, Medipace Ltd., United Kingdom

Melanie Poulin-Costello, MSc
Dir Biostatistics, Hoffmann-La Roche Ltd., Canada

Melissa Ream
AHSN, in collaboration with UK’s National Health Service, United Kingdom

Robert Scheiner, MSc
CIO, iVigee Services a.s., Czech Republic

Anja Schiel, PhD
Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA, Norwegian Medicines Agency (NoMA), Norway

Thomas Schindler, PhD
Director Global Regulatory Affairs, BioNTech, Germany

Ines Silva
Business Process Leader, Roche, United Kingdom

Alexandre Templier, PhD, MBA, MSc
President and Co-Founder, Quinten Health, France

Katherine (Kit) Valentine
Regulatory Senior Program Director, F. Hoffman La-Roche AG, United States

Paul van Geffen
Senior Manager, Quality & Regulatory Compliance, Deloitte Risk Advisory, Netherlands

Beat Walther, MBA
Managing partner, Vendbridge AG, Switzerland

Max Wegner, PharmD, RPh
Head Regulatory Affairs, Bayer AG, Germany

Ling Chao Zhang
NMPA, China

Omar Aimer
Drug and Device Safety Leader, Executive Committee, Member of ISoP, Canada

Peter Bachmann
Deputy-Head, European Union and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Emma Du Four, MBA
Head of International Regulatory Policy, AbbVie, United Kingdom

Pedro Franco, PharmD, PhD, MS, MSc
Director for Global Regulatory & Scientific Policy (GRASP), Merck Serono Limited, United Kingdom

Virginie Hivert, PharmD, PhD
Therapeutic Development Director, Eurordis-Rare Diseases Europe, France

Marianne Lunzer, DrMed
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria

Lorenz Mayr
CEO, Vector BioPharma AG , Switzerland

Heraclio Palacios Rodriguez
Regulatory Head Policy and Science LATAM, Sanofi, Panama

Jan Petracek, MD, MSc
CEO, Ivigee, Czech Republic

Céline Pulcini
Full Professor of Infectious Diseases, Université de Lorraine, France

Bettina Ryll
Member of the First EU Cancer Mission Board, MPNE, Vision Zero Cancer, Sweden

Claudine Sapède, PharmD
Director, Global HTA Policy, Novartis Pharma AG, Switzerland

Fakhredin Sayed Tabatabaei, MD, PhD
Senior Assessor, MEB, Netherlands

Christa Wirthumer-Hoche, PhD
Chair, EMA Management Board, Head, Austrian Medicines & Medical Devices Agency (AGES), Austria

Maha Al Jaghbeer
Pharmacist, Head of Drug Registration Department, Jordan Food and Drug Administration, Jordan

Frank Bretz
Distinguished Quantitative Research Scientist, Novartis Pharma AG, Switzerland

Erik Briers
Vice Chair, EUROPA UOMO, Belgium

Gregory Chen
Statistician and Data Scientist, Merck, Switzerland

Gwenael Cirefice, PharmD
Scientific Officer, European Directorate for the Quality of Medicines and Healthcare (EDQM), France

Lynne Corner
COO and Director, VOICE at the UKs National Innovation Centre for Ageing (NICA), United Kingdom

Viola Savy Dsouza, MSc
PhD Scholar, Prasanna School of Public Heath, Manipal Academy of Higher Education (MAHE), India

Falk Ehmann, MD, PhD, MS
Chair of Innovation Task Force, European Medicines Agency, Netherlands

Philippe Girard
Vice Director, Head of Licensing, Swissmedic , Switzerland

Hugo Hamel, MBA, MSc
Associate Director, BRDD, Health Canada, Canada

Claire Harrison
Chief Digital and Technology Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Derek Johnston
QA Director, Regulatory Intelligence Office, Labcorp Drug Development, United Kingdom

Dag R. Jordbru
Area director - Norwegian Medicines Agency, NOMA, Norway

Olga Kholmanskikh Van Criekingen
Clinical Assessor, CTCG Working Group member, Federal Agency for Medicines and Health Products, Belgium

Mariammah Krishnasamy
Principal Assistant Director, Head of Medical Device Registration Section, Medical Device Authority (MDA), Ministry of Health Malaysia, Malaysia

Edel Larkin
Director, Disclosures and Transparency, Gilead Sciences, Ireland

Lyne Le Palaire, MSc
Quality Advocacy Leader, Sanofi, France

Stephane Lejeune, MPH, MSc
Head International Affairs and Policies, European Organisation for Research and Treatment of Cancer (EORTC), Belgium

Lada Leyens, PhD, MSc
Regulatory Senior Program Director, F. Hoffmann-La Roche Ltd, EFPIA's Clinical Research, Switzerland

Paulo Martins
Founder & CEO, Vitruvian, Switzerland

Mafora Florah Matlala
Pharmacovigilance Manager, South African Health Products Regulatory Authority, South Africa

Margareth Ndomondo-Sigonda
Head of Health Programs, African Union-New Partnership, Africa's Development (NEPAD), South Africa

Lars Bo Nielsen
Director General, Danish Medicines Agency (DKMA), Denmark

Prisha Patel, MS
Senior Mangaer, Global Regulatory Policy, Pfizer, United Kingdom

Martina Penazzato
GAP-f, Science Division, World Health Organization (WHO), Switzerland

Andres Addis Reyes
Clinical Monitor, Roche, Venezuela

Roberto Rigobello
Senior Director, Sustainability, International Operations, Novo Nordisk, Switzerland

Rizwan Waheed Shaik, MPharm
Regulatory Affairs Specialist, Denmark

Andrei Spinei, MPharm, MSc
Scientific Administrator, European Medicines Agency, Netherlands

Rebecca Stanbrook, RPh
Executive Director, Regulatory and Development Policy, Regulatory Affairs, Novartis, Switzerland

Shannon Thor, PharmD, MS
Deputy Director, Office of Global Policy & Strategy, Europe Office, FDA, United States

Ana Trullas, PharmD, MPharm
Senior scientific specialist, European Medicines Agency, Netherlands

Britt Vermeij, PharmD
Senior Director Regulatory Policy & Intelligence Europe, Teva Pharmaceuticals; IATF Chair, Netherlands

Chantal Walther, MPharm
Head Regulatory Assessment Unit 4, Swissmedic, Switzerland

Jenna Claire Willis, PhD
Pharmacovigilance Partnering Strategy Leader, F. Hoffmann-La Roche, United Kingdom

Yue Yang, PhD, MS
Research Professor and Doctoral Supervisor, School of Pharmaceutical Sciences, Tsinghua University, China

Bettina Ziegele, MA
Chair DG SNSA of the EU-Innovation Network at EMA & Liaison Officer, Division Major Policy Issues, Paul-Ehrlich-Institut, Germany

Brian Aylward
Clinical Assessor & Chair of the PDCO FWG, EMA, Health Products Regularity Authority, United Kingdom

Federico Cimini
Qualified Person, Swissmedic, Switzerland

Jacques Demotes, MD, PhD
Director General, European Clinical Research Infrastructure Network (ECRIN), France

Georgy Genov, MD
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department, European Medicines Agency, Netherlands

Marc Gitzinger
Chief Executive Officer and co-founder, BioVersys, Switzerland

Cammilla Gomes
European Federation of the Pharmaceutical Industry - Regulatory LATAM Network, Belgium

Thomas W. Møller
Director Global Regulatory Affairs - Devices, Novo Nordisk, Denmark

Alan Morrison, PhD
Vice President Regulatory Affairs Intl, MSD, United Kingdom

Lucinda Orsini, MPH
Vice President - Value and Outcomes Research, COMPASS Pathways, United States

Lutz Wevelsiep
Managing Director, UNION Therapeutics A/S, Denmark

Gabriela Zenhaeusern, DrSc
Deputy Head Stakeholder Engagement, Swissmedic, Switzerland

Mariam Al Jalahma
CEO, National Health Regulatory Authority (NHRA), Bahrain

Christelle Anquez-Traxler, PharmD
Regulatory and Scientific Affairs Manager, AESGP, Belgium

Elena Bonfiglioli
Managing Director, Health and Life Sciences, Microsoft, Belgium

Tony Clark
Technical Director, Cambridge Spark, United Kingdom

Lucia D'Apote, DrSc, RAC
Executive Director Global Regulatory and R&D Policy (ELMAC and JAPAC), Amgen, United Kingdom

Sophie Dagens, LLM
Junior Regulatory Officer, Medicines For Europe, Belgium

Martin De Kort, PhD, MS
Senio Scientific Program Manager, EATRIS ERIC, Netherlands

Britt Dhaenens, DrMed, DrSc
MD, PHD Student, Erasmus University, Netherlands

Mark Duman
Patient Advocate, Diabetes UK, United Kingdom

François Houyez
Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURORDIS), France

Nigel Hughes, MSc
Scientific Director, Observational Health Data Analytics/Epidemiology, Janssen Research and Development, Belgium

Melissa Hunt, MSc
Director, Health Canada, Canada

Neil Mackillop
Exec Director, AstraZeneca, United Kingdom

Jerome Michaud
COO, PhenomX Health , Switzerland

Greet Musch, PhD
General Director, FAMHP, Belgium

Mark Pellett, PhD, MSc, RPh
Sr Director and Group Manager, AstraZeneca, United Kingdom

Peter Rijnbeek, PhD
Assistant Professor Medical Informatics, Erasmus Medical Center, Netherlands

Christina Schlecker, DrMed
Senior patient safety physician, Boehringer Ingelheim International Gmbh, Germany

Leire Solis
Health policy and advocacy senior manager, International Patient Organisation For Primary Immunodeficiencies (IPOPI), Belgium

Alice Vanneste, MSc
PhD researcher, KU Leuven, Belgium

Camille Vleminckx
Scientific Administrator, European Medicines Agency, Netherlands

Gülbengü Yüksel
Head of Quality, Tigen Pharma SA, Switzerland

Ditte Zerlang Andersen, PhD, MSc
Senior Regulatory Assessor, Danish Medicines Agency (DKMA), Denmark

Valentina BARBUTO
Policy Assistant, European Commission, Belgium

Giulia Gabrielli
Netherlands

Julian Isla
Chairman and Founder, Foundation 29; Scientific Director, Dravet Syndrome European Federation, Spain

Martin Landray, PhD, FRCP
Chief Executive, Protas, United Kingdom

Kristina Larsson, MS
Head of Office for Orphan Medicines, European Medicines Agency, Netherlands

Martin Leu
Head of Unit Quality Assessment of Biologics, Swissmedic, Switzerland

Larry Liberty
Temple University School of Pharmacy , United States

Dimitra Lingri
Senior Legal Expert for EOPYY/ Managing Director of EHFCN, European Healthcare Fraud & Corruption Network, Belgium

Katja Pecjak
Director of Regulatory Affairs & EU QPPV, Billev farmacija vzhod d.o.o, Slovenia

Nathalie Seigneuret, PharmD
Senior Scientific Project Manager, Innovative Medicines Initiative (IMI), Belgium

Bruno Sepodes, PharmD, PhD, MPH, MSc
Vice-Chair CHMP (EMA); Senior Expert INFARMED, INFARMED, Portugal

Tiago Villanueva
Vice-President, UEMO, Portugal

Raymond Anderson
Retired Community Pharmacist, former PRAC Member, Belgium

Franck Deveaux
HUDERF Hopital Universitaire des Enfants Reine Fabiola, Belgium

Engy El-Hosary
Head of Central Administration of Biological and Innovative Products and Clinic, Egyptian Drug Authority (EDA), Egypt

Obaidullah Malik
Director, Drug Regulatory Authority of Pakistan , Pakistan

Nermina Nakas, MD, MPH
Vice President, Medical & Scientific Strategy, Syneos Health, United States

Deka Nipom, MD
Global Safety Medical Director, Immuno-Oncology, Amgen, United States

Francisco Nogueira, MBA
Chief Executive Officer, Accumulus Synergy, United States

Representative Invited
Head of Unit 'Digital Health' unit - DG SANTE, European Commission

Charlotte Thibault
Policy Coordinator, European Pharmaceutical Students' Association (EPSA), Belgium

Slawa Troubniakov
Director, Strategy Implementation, Merck Group, Germany

Pascal Wettstein
Regulatory Expert, VolV, Switzerland

Marie Valentin, PharmD
Technical Officer, Regulatory Convergence & Networks Team [RCN], Regulation & Safety Unit [REG], Regulation & Prequalification Dept, World Health Organization, Switzerland

Rosa Castro
Senior Policy Manager for Healthcare Delivery and Networks’ Coordinator, European Public Health Alliance, Belgium

Wim Goettsch
Associate Professor, Utrecht University, Netherlands

Raun Kupiec, MS
Head of Global Regulatory Affairs, Vifor Pharma Management , Switzerland

Yann Le Cam, MBA
Chief Executive Officer, Eurordis-Rare Diseases Europe, France

Jessica Liu
VP, M&A Management Department, Tigermed Consulting, China

David Mukanga
Deputy Director, Africa Regulatory Systems, Bill and Melinda Gates Foundation, United States

Patricia Oliveira Pereira Tagliari, LLM, MPH
Associate Director, Brazilian Health Regulatory Agency - ANVISA, Brazil

Mariana Santos, PharmD, LLM, MPharm, MSc
International Affairs Officer, PharmD, MSc, European Medicines Agency, Netherlands

Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jorge Batista
Professional Affairs Advisor, PGEU, Belgium

Najla Chebib
Co-founder & CEO, OrCa, Switzerland

Lucia Perez-Kempner
Senior Consultant, Parexel International, Spain

Elizabeth Vroom
President, Duchenne Parent Project, Netherlands

Weidong (David) Yu, PhD
PK Scientist, Biopharma Services Inc., Canada

Bunmi Femi-Oyekan
Director, Regulatory Affairs, Pfizer Specialities Ltd, Nigeria

Ansgar Hebborn, PhD, MBA
Head - Access Policy Affairs Europe, F. Hoffmann-La Roche AG, Switzerland

Kasper Bendix Johnsen
Head of Section, Danish National Center For Ethics, Denmark

Deepika Lakhani
Vice President, Regulatory and Quality, PAVmed Inc., United States

Patrick Middag, MBA, MSc
Director, Deloitte Risk Advisory, Belgium

Cornelia Bigler Weber
SwissMed, Switzerland

Zilke Claessens, MHS
PhD Researcher, KU Leuven, Belgium

Fredrik Harenstam
VP of Business Development, Elypta, Sweden

Sabine Schneider
Vice President Global Government Relations, Labcorp, Switzerland

Boitumelo Semete-Makokotlela
CEO, SAHPRA, South Africa

Petra Bettendorf
Head of Regulatory Affairs Region, Boehringer Ingelheim International GmbH, Germany

Laura Oliveira
Regulatory Affairs, Director, MSD Spain , Spain

Jorge Batista, MPharm
University of Algarve, Portugal

Bjorg Hunter, MSc
Director, Novo Nordisk, Denmark

Andrew Bruce
Health Policy and Reimbursed Director, Amgen, Belgium

Tim Chesworth
Senior Director Regulatory Affairs, AstraZeneca, United Kingdom

Philippe Page, DrSc
Head of Knowledge Sharing, Trustee, The Human Colossus Foundation, Switzerland

Klaus Hammer
Head of Regulatory, PeriVision, Switzerland

Francoise Sillan, MD
VP GPS TA ENDO-ONCO & EU QPPV, Ipsen, France

Delese Mimi Darko, MBA, RPh, RAC
Chief Executive Officer, Food and Drugs Authority, Ghana

Baher Higazy
Co-Founder & Chief Medical Officer, Consulto Care, Switzerland

Sina Schader, DrMed
EU and UK QPPV, AbbVie, Germany

Ronnie Harprit Mundair
Regional Labelling Head - AfME, Canada and LATAM - Senior Director, Pfizer, United Kingdom

Edith Frénoy, MA, MSc
Director, European Public Policy – Strategic EU Advocacy Lead, MSD Europe Inc., Belgium

Aleksandar Ruzicic
Healthcare Consultants, Executive Insight AG, Switzerland

Sponsors & Partners

2023 Sponsors

GOLD SPONSORS:
• NNIT
• Propharma
• Quinten-Health
• RWS
• Basel.ch

SILVER SPONSORS:
• G&L Healthcare Advisors
• H1
• IQVIA
• KPMG
• MTG
• Primevigilance
• Productlife
• Pharmalex
• ServiceNow
• SeproTec
• Veeva
• Yseop

BRONZE SPONSORS:
• Arex-Advisor
• Asphalion logo
• August Research
• Axian Consulting
• Barrington James
• Biomapas-200x75
• Cegedim Health Data
• Croissance Clinical Research
• ClinChoice-Inc.
• DADA
• Extedo
• INCONSULT GmbH
• Ivigee
• MedDRA MSSO
• Nextrove
• OwlPharma-Consulting Lda.
• P-95
• PPD
• Pharmazones
• Replica Analytics
• SFL
• TigerMed
• ValGenesis

SUPPORTERS:
• Acolad Life Sciences
• Awinsa
• Almac Group
• AFCROs
• Amplexor
• Biologit
• Critical Path Institute
• Croissance Clinical Research
• Copyright Clearence Center
• Drug Safety Research Unit
• DLRC
• DDReg Pharma Pvt Ltd.
• European Directorate for the Quality of Medicines & HealthCare
• DIA Europe | EMA
• Empatica Srl
• Generis
• Insuvia
• Ideagen
• Loftware
• Metronomia Clinical Research GmbH
• NES-UK-Limited
• PMDA-Pharmaceuticals-and-Medical-Devices-Agency
• Paul-Ehrlich-Institut
• Pharma D&S
• Pharmathen
• Premier Research
• RAPS
• DIA Europe | Swissmedic
• United Language Group
• Uppsala Monitoring Centre
• UL Solutions