Speakers and Panellists

More speaker details to be announced across all programmes.

 


HM1: A Decade of Innovative Clinical Trials: What Have We Learned and Where Are We Going? | 17 October 2022

Leader

Susan Bhatti

Director EU Global Regulatory and Scientific Policy
Merck BV, the Netherlands





 

Leader

Francesca Buttigieg

Associate Director Regulatory Affairs
PTC Therapeutics, Switzerland





 

Speaker

Mireille Muller

Regulatory Policy Executive Director
Novartis, Switzerland





 

Speaker

Anja Schiel

Alternate Member, Scientific Advice Working Party at European Medicines Agency
Norwegian Medicines Agency, Norway





 

Panellist

Marianne Lunzer

PV und CT Safety Assessor
Austrian Medicines and Medical Devices Agency (AGES), Austria





 

HM2: Are Expedited Programs Delivering on the Promise to Accelerate Drug Development and Patient Access? | 17 October 2022

Leader

Laura Liebers

Director, International Regulatory Policy & Intelligence
United Kingdom





 

Leader and chair

Carlos Langezaal

Senior Director, Global Regulatory Affairs
BMS, USA


 


 

Speaker

Fred Senatore

Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research
U.S. Food and Drug Administration (FDA), USA





 

Speaker

Daniel O’Connor

Deputy Director, Innovation Accelerator and Regulatory Science
MHRA, United Kingdom


 


 

Tim Stonehouse

Panellist

Tim Stonehouse

Vice President – International Regulatory Strategy
Vertex, United Kingdom


 


 

HM3: Lessons Learned and Strategic Priorities | 17 October 2022

Daniela Drago

Leader and chair

Daniela Drago

Expert Consultant,
NDA Partners, USA





 

Leader and chair

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication
European Medicines Agency (EMA)


 


 

Speaker

Emer Cooke

Executive Director
European Medicines Agency (EMA)


 


 

Speaker

Christa Wirthumer-Hoche

Head of Austrian Medicines and Medical Devices Agency (AGES)
Austria





 

Speaker

Robert Califf

Commissioner of Food and Drugs
U.S. Food and Drug Administration (FDA), USA





 

HM4: Assessing the value of Innovative Therapies: Trends, Challenges, and Learnings | 18 October 2022

Leader

Carlos Langezaal

Senior Director, Global Regulatory Affairs
BMS, USA





 

Tina Wang

Speaker

Tina Wang

Senior Manager, HTA programme and Strategic Partnership
Centre for Innovation in Regulatory Science (CIRS), United Kingdom




 

Michael Berntgen

Speaker

Michael Berntgen

Head of Product Development Scientific Support Department
European Medicines Agency (EMA)




 

Claudia Wild

Speaker

Claudia Wild

CEO
Austrian Institute for Health Technology Assessment (AIHTA), Austria




 

HM5MD1: Digital Health Opportunities and Advancements in Healthcare | 18 October 2022

Chair and leader

Bjorg K Hunter

Department Affairs Director, Regulatory Affairs Digital Health
Novo Nordisk, Denmark




 

HM6: Innovation in Regulatory Science: The Path from Data to Evidence and the Promise to Streamline the Regulatory Lifecycle | 18 October 2022

Leader and Chair

Guenter Waxenecker  

Nonclinical and Biological Assessor
Austrian Agency for Health and Food Safety (AGES), Austria





 

Leader and speaker

Fred Senatore

Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research
U.S. Food and Drug Administration (FDA), USA





 

Speaker

Frank Nogueira

CEO
Accumulus Synergy, USA





 

Álmath Spooner

Speaker

Álmath Spooner

Director Global Regulatory Policy and Intelligence
Abbvie, Ireland




 

Christian Gartner

Panellist

Christian Gartner

Biostatistician, Senior Expert
Austrian Medicines and Medical Devices Agency (AGES), Austria


 


 

HM7: Are Patients Still the Missing Piece in the Global Drug Development Puzzle? | 19 October 2022

Leader

Susan Bhatti

Director EU Global Regulatory and Scientific Policy
Merck BV, the Netherlands





 

Michael Berntgen

Leader

Sabine Ellenberger

Director, International Regulatory Affairs
Blueprint Medicines, Switzerland





 

Jo Dewhurst

Speaker

Jo Dewhurst

Director, Therapeutic Expertise
ICON plc, United Kingdom


 


 

Speaker

Maria Mavris

Patient Relations
European Medicines Agency (EMA)


 


 

Jo Dewhurst

Speaker

Claas Röhl

Patient representative, NF Patients United
EUPATI, Austria


 


 

HM8: The Present and Future of Developing and Commercializing Cell and Gene Therapies in a Global World | 19 October 2022

Leader

Francesca Buttigieg

Associate Director Regulatory Affairs
PTC Therapeutics, Switzerland





 

Speaker

Martina Schuessler-Lenz

Chair of the Committee for Advanced Therapies (CAT), European Medicines Agency (EMA) and Paul-Ehrlich-Institut
Germany


 


 

Speaker

Julie Taccoen

Senior Director, Regulatory Affairs
PTC Therapeutics, France





 

Patrick Celis

Panellist

Patrick Celis

Scientific Administrator, Committee for Advanced Therapies (CAT)
European Medicines Agency (EMA)


 


 

HM9: Strategy Under Uncertainty – Improving the Odds of Regulatory Success | 19 October 2022

Daniela Drago

Leader and speaker

Daniela Drago

Expert Consultant
NDA Partners, USA





 

Speaker

Carlos Langezaal

Senior Director, Global Regulatory Affairs
BMS, USA


 


 

Speaker

Fortunato Fred Senatore

Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research
U.S. Food and Drug Administration, USA





 

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TOPRA Symposium 2022
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