Speakers and Panellists

HM1: A spotlight on CEE – Challenges and Opportunities in Central and Eastern European Countries | 22 September 2021

Leader and Chair

Eva Kopecna  

Head of Global Regulatory Affairs, Medical and Pharmacovigilance
Accino, Switzerland





 

Leader, chair and speaker

Tomáš Boráň

Director of the Marketing Authorisation Section
SÚKL, Czech Republic





 

Speaker

Nataliya Burlakina

GMP Inspector
State Institute of Drugs and Good Practices, Russian Federation


 


 

Filip Vrubel

Speaker

Filip Vrubel

Executive Director
Czech Association of Pharmaceutical Companies, Czech Republic


 


 

HM2: Fireside Chat with Emer Cooke - A Review of Current and Future Priorities | 22 September 2021

Daniela Drago

Leader

Daniela Drago

Chief Regulatory Officer
Aurion Biotech, USA





 

Speaker

Emer Cooke

Executive Director
European Medicines Agency (EMA)


 


 

HM3: The evolution of the EMA-EUnetHTA collaboration - bridging of decision makers | 22 September 2021

Chair

Carlos Langezaal

Senior Director, Global Regulatory Affairs
BMS, USA





 

Michael Berntgen

Speaker

Michael Berntgen

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





 

Michael Berntgen

Speaker

Niklas Hedberg

Chief Pharmacist
EUnetHTA / TLV, Sweden




 

Speaker

Flora Giorgio

Deputy Head of Unit B6, DG Sante
European Commission


 


 

HM4: Real world evidence in regulatory decision-making | 22 September 2021

Leader and chair

Francesca Buttigieg

Associate Director Regulatory Affairs
PTC Therapeutics, Switzerland





 

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, USA





 

Speaker

Robert Kalesnik-Orszulak

Regulatory Innovation Lead for RWE & Data Science, Global Regulatory Strategy & Policy
BMS, USA


 


 

Xavier Kurz

Speaker

Xavier Kurz

Head of Data Analytics
European Medicines Agency (EMA)


 


 

HM5: Reliance, worksharing and recognition as 21st century regulatory tools | 22 September 2021

Leader and chair

Francesca Buttigieg

Associate Director Regulatory Affairs
PTC Therapeutics, Switzerland





 

Speaker

Murray Lumpkin

Deputy Director Integrated Development (Lead for Global Regulatory Systems Initiatives)
Bill & Melinda Gates Foundation





 

martin-harvey-allchurch

Speaker

Martin Harvey Allchurch

Principal International Affairs Officer
European Medicines Agency





 

martin-harvey-allchurch

Speaker

Heidi Wang

Vice President, Head of Oncology, Global Regulatory Strategy & Policy
BMS, US





 

TOPRA Annual Lecture: From ‘knocking on the door’ to co-creation: 25 years of patient engagement in R&D | 23 September 2021

martin-harvey-allchurch

Annual Lecture Speaker

Virginie Hivert

Therapeutic Development Director
EURORDIS France





 

HM6: Clinical trials of the future – patient oriented and digitally connected | 23 September 2021

Leader and chair

Susan Bhatti

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





 

Leader and chair

Carlos Langezaal

Senior Director, Global Regulatory Affairs
BMS, USA


 


 

Speaker

Tanja Keiper

Director Clinical Trial Execution, Clinical Delivery Unit
Merck Healthcare, Germany


 


 

Speaker

Isaac Rodriguez-Chavez

Senior Vice President, Scientific & Clinical Affairs Head
Icon, USA





 

Speaker

Fergus Sweeney

Head, Clinical Studies and Manufacturing Taskforce
European Medicines Agency (EMA)




 

Panellist

Ann-Marie Janson Lang 

CTFG co-chair
MPA, Sweden





 

HM7: Regulatory progress in delivering on the promise of ATMPs | 23 September 2021

Leader, chair and panellist

Tomáš Boráň

Director of the Marketing Authorisation Section
SUKL, Czech Republic





 

Daniela Drago

Leader

Daniela Drago

Chief Regulatory Officer
Aurion Biotech, USA





 

Wilson Bryan

Speaker

Wilson W. Bryan

Director of the Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research (FDA), USA




 

ana-hidalgo-simon

Speaker

Ana Hidalgo-Simon   

Head of Advanced Therapies
European Medicines Agency (EMA)




 

Panellist

Michael Ladd

VP Regulatory Science
Orchard Therapeutics




 

Christelle Bouygues

Speaker

Angelo Loris Brunetta

Board member of Thalassaemia International Federation and former member of the Committee for Orphan Medicinal Products (COMP), Italy





 

HM8: Enhancing dialogue to foster innovation | 24 September 2021

Leader and chair

Susan Bhatti

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





 

Speaker

Carlos Langezaal

Senior Director, Global Regulatory Affairs
BMS, USA


 


 

Iordanis Gravanis

Speaker

Iordanis Gravanis

Head of Scientific Advice
European Medicines Agency (EMA)


 


 

Claudia Hey

Speaker

Claudia Hey   

Senior Director Global Regualtory and Scientific Policy Europe
Merck Healthcare, Germany


 


 

HM9MD5: Innovation in drug-device combinations – how to navigate a complex regulatory environment? | 24 September 2021

Chair and leader

Bjorg K Hunter

Department Manager, Regulatory Affairs NextGen Drug-device
Novo Nordisk, Denmark




 

Christelle Bouygues

Speaker

Christelle Bouygues

Regulatory Affairs Officer
European Medicines Agency (EMA)





 

Christelle Bouygues

Speaker

John (Barr) Weiner   

Associate Director for Policy and Product Classification Officer
FDA, USA





 

Speaker

Manfred Maeder

Global Head Device Development & Commercialization
Novartis, Switzerland


 


Panellist

Nada Alkhayat

Policy Officer – Medical Devices, Unit B6, DG Sante
European Commission 



 

 


HM10: Avoiding disastrous mistakes with an effective regulatory strategy | 24 September 2021

Daniela Drago

Leader

Daniela Drago

Chief Regulatory Officer
Aurion Biotech, USA





 

Leader and speaker

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, USA





 

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TOPRA Symposium 2021

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