Speakers and Panellists

The list of speakers and panellists for the 2020 TOPRA Symposium is being finalised. You can see the list of confirmed participants below.

If you would like to be notified when additional participant details are announced, please email meetings@topra.org

Speakers & panellists

Samvel Azatyan

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks, Unit Head a.i., Regulation and Safety
World Health Organisation (WHO)



Session: HM2 - Expansion of regulatory innovation in other markets
When: 5 October | 12:30 – 14:00 BST (GMT+1)


 

Susan Bhatti

Susan Bhatti

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

Topic: Capturing the patient voice on benefits and risks of medicinal products

Session: HM8 - Patient centricity in regulatory affairs and involvement in evidence generation
When: 7 October | 14:15 – 15:45 BST (GMT+1)


Erik Briers

Erik Briers

Expert Patient Advocate - Board Member
Patient Expert Committee - Belgium

Topic: The patient experience of patient-centric research

Session: HM8 - Patient centricity in regulatory affairs and involvement in evidence generation
When: 7 October | 14:15 – 15:45 BST (GMT+1)


Tim Chesworth
Tim Chesworth

Senior Director Regulatory Affairs - Medical Devices & Combination Products
AstraZeneca - UK

 

Session: PS1- Combined products - Drugs, devices, IVDs, software - how to regulate and innovate?
When: 6 October | 10:15 – 11:45 BST (GMT+1)


Xavier de Cuypers

Xavier de Cuyper

Chief Executive Officer
Federal Agency for Medicines and Health Products (FAMHP) - Belgium

 

Session: HM1: Driving the healthcare regulatory system into the future
When: 5 October | 9:00 – 10:30 BST (GMT+1)


Fabio D'Atri

Fabio D'Atri

Policy Officer, Unit B5, DG Sante
European Commission

 

Session: HM3 - Orphan and paediatric policy updates
When: 5 October | 16:00 – 17:30 BST (GMT+1)


 

 

Sini Eskola

Sini Eskola

Director, Regulatory, Drug development and Manufacturing
European Federation of Pharmaceutical Industries (EFPIA) - Belgium

 

Session: HM1: Driving the healthcare regulatory system into the future
When: 5 October | 9:00 – 10:30 BST (GMT+1)



Ben Forbes

Professor of Pharmaceutics
King’s College London - UK

 
Session: PS1- Combined products - Drugs, devices, IVDs, software - how to regulate and innovate?
When: 6 October | 10:15 – 11:45 BST (GMT+1)


Maren von Fritschen

Maren von Fritschen

Regulatory Affairs
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) - Belgium

 

Session: HM7 - Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning?
When: 7 October | 10:45 – 12:15 BST (GMT+1)


Flora Giorgio

Flora Giorgio
Head of Sector, HTA, DG SANTE
European Commission

Topic: Learnings from the exchange between EMA and HTA bodies at market entry and in view of PLEG planning

Session: HM7 - Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning?
When: 7 October | 10:45 – 12:15 BST (GMT+1)

Niklas Hedberg

Niklas Hedberg
Chair, European Network for Health Technology Assessment (EUnetHTA)
Chief Pharmacist, The Dental and Pharmaceutical Benefits Agency (TLV) - Sweden

 

Topic: Review of joint production by EUnetHTA and opportunities for development planning

Session: HM7 - Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning?
When: 7 October | 10:45 – 12:15 BST (GMT+1)


Paula van Hennik

Paula van Hennik

Clinical Assessor
Medical Evaluation Board (MEB) - the Netherlands

 

Topic: Learnings from the exchange between EMA and HTA bodies at market entry and in view of PLEG planning

Session: HM7 - Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning?
When: 7 October | 10:45 – 12:15 BST (GMT+1)


Nick Hicks
Nick Hicks

Principal Consultant
Commutateur Advocacy Communication - France

 

Session: PS1- Combined products - Drugs, devices, IVDs, software - how to regulate and innovate?
When: 6 October | 10:15 – 11:45 BST (GMT+1)


Christiana Hoffman
Christiana Hoffman

Team lead Non-active Devices and Article 117 MDR
TÜV SÜD - Germany

 

Session: PS1: Combined products - Drugs, devices, IVDs, software - how to regulate and innovate?
When: 6 October | 10:15 – 11:45 BST (GMT+1)


Ann Jans

Ann Jans

Medical Devices Quality Assessor
Federal Agency for Medicines and Health Products (FAMHP) - Belgium

Topic: Perspective of a national CA to support innovation of medical products

Session: HM5MD1 - Innovation and regulation at the interface of medicines, devices and companion diagnostics
When: 6 October | 15:00 – 16:30 BST (GMT+1)


Ann Marie Janson Lang

Ann Marie Janson Lang

CTFG co-chair
Medical Products Agency (MPA) - Sweden

 

Session: HM6 - Innovation in clinical trials
When: 6 October | 16:45 – 18:15 BST (GMT+1)


Theresa Jeary

Theresa Jeary

Technical Specialist and Scheme Manager
BSI - UK 

Topic: Innovative borderline products challenging current regulations

Session: HM5MD1 - Innovation at the interface of medicines, devices and companion diagnostics
When: 6 October | 15:00 – 16:30 BST (GMT+1)


Kaja Kantorska

Kaja Kantorska

Policy Officer, Unit B5, DG Sante
European Commission

 

Session: HM3 - Orphan and paediatric policy updates
When: 5 October | 16:00 – 17:30 BST (GMT+1)


Diane Jorkasky

Diane Jorkasky MD, FACP

Principal, Strategic Consultant
Diane K Jorkasky Consulting - USA

Topic: Challenges and opportunities in clinical trials' innovation: a physician voice with an industry perspective

Session: HM6 - Innovation in clinical trials
When: 6 October | 16:45 – 18:15 BST (GMT+1)


Yasuhiro Kishioka

Yasuhiro Kishioka

MHLW/PMDA Liaison Official, International Affairs Division
European Medicines Agency



Session: HM2 - Expansion of regulatory Innovation in other markets
When: 5 October | 12:30 – 14:00 BST (GMT+1)


Thomas Kuhler

Thomas Kühler
Head Global Regulatory Science & Policy EU/AMESA
Sanofi - France

 

Session: HM2 - Expansion of regulatory Innovation in other markets
When: 5 October | 12:30 – 14:00 BST (GMT+1)


Christophe Lahorte

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

Topic: Engaging with patients and patient representatives during scientific advice and early clinical development

Session: HM8 - Patient-centricity in regulatory affairs and involvement in evidence generation
When: 7 October | 14:15 – 15:45 BST (GMT+1)


Maria Mavris

Maria Mavris

Patients and Consumers Liaison
European Medicines Agency (EMA)

Panellist

Session: HM8 - Patient-centricity in regulatory affairs and involvement in evidence generation
When: 7 October | 14:15 – 15:45 BST (GMT+1)


Krystin Meidell

Krystin Meidell

Senior Manager Regulatory Affairs, CMC Medical Devices & Combination Products
Biogen - United States

Topic: Global development of IVDs, including companion diagnostics for personalised medicine

Session: HM5MD1 - Innovation at the interface of medicines, devices and companion diagnostics
When: 6 October | 15:00 – 16:30 BST (GMT+1)


Koenraad Norga

Koenraad Norga

Paediatric Committee (PDCO) chair
Universitair Ziekenhuis Antwerpen - Belgium

 

Session: HM3 - Orphan and paediatric policy updates
When: 5 October | 16:00 – 17:30 BST (GMT+1)


Laurence O'Dwyer

Laurence O'Dwyer

Scientific Affairs Manager
Health Products Regulatory Authority (HPRA) - Ireland

 

Session: HM4 - Regulatory support to research and development
When: 6 October | 10:15 –11:45 BST (GMT+1)


Marie-Helene Pinheiro 
Marie-Helene Pinhiero

Industry Stakeholder Liaison, European Medicines Agency (EMA)
European Medicines Agency (EMA)

Panellist

Session: HM2 - Expansion of regulatory innovation in other markets
When: 5 October | 12:30 – 14:00 BST (GMT+1)


Guido Rassi

Guido Rasi

Executive Director
European Medicines Agency (EMA)



Session: HM1: Driving the healthcare regulatory system into the future
When: 5 October | 9:00 – 10:30 BST (GMT+1)


Armin Ritzhaupt

Armin Ritzhaupt

Scientific Administrator, Regulatory Affairs Office
European Medicines Agency (EMA)

Topic: Update from EMA on regulatory strategy initiatives

Session: HM5MD1 - Innovation and regulation at the interface of medicines, devices and companion diagnostics
When: 6 October | 15:00 – 16:30 BST (GMT+1)


Thomas Senderovitz

Thomas Senderovitz

Director General
Danish Medicines Agency (DKMA) - Denmark


Session: HM1: Driving the healthcare regulatory system into the future
When: 5 October | 9:00 – 10:30 BST (GMT+1)


Jessica Shull
 Jessica Shull

European Lead
Digital Therapeutics Alliance

 

Panellist
Session: PS1- Combined products - Drugs, devices, IVDs, software - how to regulate and innovate?
When: 6 October | 10:15 – 11:45 BST (GMT+1)


Olga Solomon

Olga Solomon

Head of Unit B5, DG Sante
European Commission



Session: HM1: Driving the healthcare regulatory system into the future
When: 5 October | 9:00 – 10:30 BST (GMT+1)


Elke stahl

Elke Stahl

Assessor Clinical Trials and CTFG Co-chair
Federal Institute for Drugs and Medicinal Devices (BfArM) - Germany



Session: HM6 - Innovation in clinical trials
When: 6 October | 16:45 – 18:15 BST (GMT+1)


Thorsten Vetter
Scientific Administrator, Scientific Advice Office
European Medicines Agency (EMA)
 

 

Session: HM4 - Regulatory support to research and development
When: 6 October | 10:15 –11:45 BST (GMT+1)


John Wilkinson
John Wilkinson

Chair
Global Medical Device Nomenclature Agency - UK


 

Session: PS - Combined products - Drugs, devices, IVDs, software - how to regulate and innovate?
When: 6 October | 10:15 – 11:45 BST (GMT+1)


 

Debra Yeskey

Debra Yeskey

Head of Regulatory Affairs, North America
Coalition for Epidemic Preparedness Innovations (CEPI) - USA

Topic: Epidemic preparedness

Session: Annual Lecture
When: 29 September | 14:30 – 15:30 BST (GMT+1)

Session Chairs and Leaders

Michael Berntgen

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

Session Leader & Chair: HM7 - Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning?

When: 7 October | 10:45 – 12:15 BST (GMT+1)

 


Susan Bhatti

Susan Bhatti

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

Session Leader & Chair: HM8 - Patient-centricity in regulatory affairs and involvement in evidence generation

When: 7 October | 14:15 – 15:45 BST (GMT+1)

 


Francesca Buttigieg

Francesca Buttigieg

Global Program Regulatory Manager
Novartis - Switzerland

Session Leader: HM6 - Innovation in clinical trials

When: 6 October | 16:45 – 18:15 BST (GMT+1) 

 


Daniela Drago

Daniela Drago

Senior Director, Regulatory Sciences
Biogen - United States

Session Leader: HM6 - Innovation in clinical trials

When: 6 October | 16:45 – 18:15 BST (GMT+1)

 


Joao Duarte

João Duarte

Director, Regulatory Science and Chief of Staff, Global Regulatory Affairs
Alexion - France

Session Leader: HM3 - Orphan and paediatric policy updates

When: 5 October | 16:00 – 17:30 BST (GMT+1)

 


Falk Ehmann

Falk Ehmann

Head of Innovation Task Force
European Medicines Agency (EMA)

Session: HM4 - Regulatory support to research and development

When: 6 October | 10:15 – 11:45 BST (GMT+1)


Janine Jamieson

Janine Jamieson

EU Editor
International Pharmaceutical Quality Publications -Sweden

Session Leader and Chair: HM5MD1 - Innovation at the interface of medicines, devices and companion diagnostics

When: 6 October | 15:00 – 16:30 BST (GMT+1)

 


Carlos Langezaal

Carlos Langezaal

Senior Director, Global Regulatory Affairs
Bristol-Myers Squibb - United States

Session Leader and Chair: HM2 - Expansion of regulatory innovation in other markets

When: 5 October | 12:30 – 14:00 BST (GMT+1)

 


Jordi Linares Garcia

Jordi Llinares Garcia
Head of Research and Innovation
European Medicines Agency (EMA)

Session Leader & Chair: HM4 - Regulatory support to research and development

When: 6 October | 10:15 – 11:45 BST (GMT+1)
 

Greet Musch

Greet Musch

General Director DG PRE authorisation
Federal Agency for Medicines and Health Products (FAMHP) - Belgium

Session Leader: HM1 - Driving the healthcare regulatory system into the future

When: 5 October | 9:00 – 10:30 BST (GMT+1)


Armin Ritzhaupt

Armin Ritzhaupt

Scientific Administrator, Regulatory Affairs Office
European Medicines Agency (EMA)

Session Leader: PS1 - Combined products - Drugs, devices, tissues, IVDs, software - how to regulate and innovate?

When: 6 October | 15:00 – 16:30 BST (GMT+1)


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TOPRA Symposium 2020
Pre-event session: 29 September
Symposia: 5–8 October
Online

Contact us
meetings@topra.org
+44 (0)207 510 2560

#TOPRASym20

 

Exhibition / Sponsorship
Call +44 (0)2076 510 2573
or email erik@topra.org