Speakers and Panellists

See below which speakers were in attendance at the 2023 TOPRA Annual Symposium.

HM1: Update on EU new regulatory legislation and a view from different angles (European Medicines Agency (EMA), industry, others) | 23 October 2023

Session Leader

Julie Taccoen
Senior Director, Regulatory Affairs, EU
PTC Therapeutics France, France





 

Session Leader

Marta Marcelino
Head of Medicines Evaluation Department PT CMDh member
Infarmed, Portugal





 

Speaker

Olga Soloman
Head of unit for medicines: policy, authorization and monitoring (B5)
European Commission, Belgium





 

Speaker

Dr. Paula Loekemeijer
Executive Director
Medicines Evaluation Board (MEB), the Netherlands





 

Speaker

Valentin Plouchard
Healthcare Regulatory Affairs Manager
EuropaBio, Belgium





 

Panellist

María Jesús Lamas Díaz
Executive Director
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)/ Spanish Agency of Medicines and Medical Products, Spain





 

Panellist

Prof. Steffen Thirstrup
Chief Medical Officer
European Medicines Agency (EMA), the Netherlands





 

HM2: Improving the Odds of Regulatory Success | 23 October 2023

Session Leader and Speaker

Carlos Langezaal
Senior Director, Global Regulatory Affairs,
Bristol Myers Squibb (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

Michael Berntgen
Head of Scientific Evidence Generation Department
EMA, the Netherlands





 

HM3: A spotlight on to the future - Fireside Chat | 23 October 2023

Session Leader

Francesca Buttigieg

Director Regulatory Affairs
PTC Therapeutics International Limited, Switzerland





 

Session Leader

Sabine Haubenreisser

Principal Scientific Administrator - Stakeholders and Communication
EMA, the Netherlands





 

Speaker

Prof. Steven Thirstrup

Chief Medical Officer
European Medicines Agency (EMA), the Netherlands


 


 

Speaker

Prof. Bruno Sepodes
Vice-Chair of CHMP (EMA)
Infarmed/University of Lisbon, Portugal


 


 

HM4: The evolving clinical trial landscape | 24 October 2023

Session Leader
 

Dr. Carlos Alves
Vice-President
Infarmed, Portugal




 

Speaker
 

Olga Kholmanskikh
Clinical Assessor
Federal Agency for Medicines and Health Products (FAHMP), Belgium





 

Speaker
 

Marianne Lunzer
CTCG Chair
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES)/ Austrian Agency for Health and Food Safety, Austria





 

Speaker
 

Björn Eriksson
Director General
Läkemedelsverket/Medical Product Agency (MPA), Sweden





 

Panellist
 

Pierre-Frédéric Omnes 
Executive Director, Life Sciences
Transperfect, France



 


 

TOPRA Annual Lecture: Opportunities and challenges for healthcare in the future | 24 October 2023

Speaker

Dr Miguel Forte

Managing Director
mC4Tx, Belgium, and President-Elect, International Society for Cell and Gene Therapy, Belgium and Canada




 

HM5/MD1/IVD1: Process for regulations and implications of different legislation – how to follow and decide which regulation will impact your product development | 24 October 2023

Session Leader

Bjørg Hunter
Director, Regulatory Affairs Digital Health & IVD
Novo Nordisk, Denmark




 

Speaker

Barr Weiner
Associate Director, Office of Combination Products
U.S. Food and Drug Administration (FDA), USA




 

Speaker

Claudia Popp
Head of EU Regulatory Science and EMA Liaison
Roche, Switzerland




 

Speaker

Stiina Aarum
Senior Scientific Specialist
EMA, the Netherlands




 

Panellist

Dr. Lena Björk
Director Supervision
Läkemedelsverket/Medical Products Agency (MPA), Sweden




 

Panellist

Lorraine Nolan
Chief Executive
Health Products Regulatory Authority (HPRA), Ireland





 

HM6: Real world evidence (RWE) and the use of big data for regulatory decision making; DARWIN EU | 24 October 2023

Session Leader
 

Dr. Marén Koban
Director Global Regulatory and Scientific Policy
Merck Healthcare KGaA, Germany





 

Session Leader
 

Àlmath Spooner
Head of Europe, Regulatory Policy and Intelligence
Abbvie, Ireland





 

Speaker
 

Meritxell Sabidó
Director Epidemiology
Merck Healthcare KGaA, Germany





 

Speaker

Andrej Segec

Scientific Administrator
EMA, the Netherlands





 

Speaker

Dr. Kimberly Smith

Medical Officer
U.S. Food and Drug Administration (FDA), USA





 

Panellist

Cláudia Furtado
Head of the Health Technology Assessment (HTA), Pricing and Reimbursement Division (DATS)
Infarmed, Portugal 





 

HM7: Paediatric Investigational Plans | 25 October 2023

Session Leader

Dr. Andrea Laslop
Head of Scientific Office
Austrian Medicines and Medical Devices Agency (MEA), Austria






 

Session Leader

Sandra Lourenço

Head of Regulatory Affairs
Arriello, Ireland





 

Speaker

Prof. Ignacio Malagon

Prof. of Paediatric Anaesthesia
Radboud UMC, the Netherlands





 

Speaker

Karl Heinz Heumer

Consultant
KHH Consultancy, Austria





 

Speaker

Dr. Martine Dehlinger-Kremer
Vice President Scientific Affairs, Pediatric Subject Matter Expert
Icon-PLC & President EUCROF, Germany





 

Panellist

Chrissi Pallidis

Senior Scientific Specialist
EMA, the Netherlands





 

Panellist

Solange Corriol-Rohou

Senior Director Regulatory Affairs & Policy
AstraZeneca, France





 

PS1: Health Technology Assessments – the new EU regulation | 25 October 2023

Session Leader


Mariane Cossito
Head of Medicines Evaluation and Access Management Unit
Infarmed, Portugal





 

Session Leader

Carlos Langezaal
Senior Director, Global Regulatory Affairs
Bristol Myers Squibb (BMS), USA





 

Speaker

Dr. Tina Wang

Senior Manager, HTA Strategic Partnership
Centre for Innovation in Regulatory Science (CIRS), UK





 

Speaker

Rui Santos Ivo
Presdient of Infarmed
Infarmed, Portugal





 

Speaker

Roisin Adams
Head at HTA Strategy and External Engagement National centre for Pharmacoeconomics, NCPE
National Centre for Pharmacoeconomics, Ireland






 

Panellist

Michael Berntgen
Head of Scientific Evidence Generation Department
EMA, the Netherlands





 

HM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME) | 25 October 2023

Session Leader
 

Marie Uguen
Senior VP, Regulatory Affairs & Quality Assurance,
SparingVision, France





 

Speaker
 

Laurence Campion
Regulatory Affairs Director
PTC Therapeutics France, France





 

Speaker
 

Dr Christian K. Schneider
Vice President, Head of Biopharma Excellence, Chief Medical Officer (Biopharma)
PharmaLex, Denmark





 

Panellist
 

Dr. Kevin Cunningham
EMA PRIME Scientific Coordinator
EMA, the Netherlands





 

Panellist
 

Momir Radulović
Executive Director
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)/ Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Slovenia





 

HM9: Patient intervention in the decision making process | 25 October 2023

Session Leader

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 





 

Session Leader

Sabine Haubenreisser
Principal Scientific Administrator - Stakeholders and Communication
EMA, the Netherlands





 

Speaker

Maria Mavris

Patient Relations
EMA, the Netherlands





 

Speaker

Andrea Furia-Helms

Director, Patient Affairs
U.S. Food and Drug Administration (FDA), USA





 

Speaker

Dr. Maren von Fritshcen
Head Regulatory Policy Europe
Moderna, Germany





 

Speaker

Dr. Kieran Breen
Research Advisor
Parkinson‘s Europe, United Kingdom





 

PS2: ATMP innovations and clinical trials with GMOs | 25 October 2023

Session Leader

Jayne Hunt

Principal Regulatory Affairs Consultant
Ariello, Ireland




 

Speaker

Dr. Patrick Ginty

Senior Director, Regulatory Affairs
Boyds, UK





 

Speaker

Pierre-Frédéric Omnes
Executive Director, Life Sciences
TransPerfect, France




 

Speaker

Maria Isabel Vieira
Non-clinical Farmacotoxicologist Assessor
Infarmed, Portugal




 

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TOPRA Symposium 2023
Lisboa Congress Centre, 
Praça das Indústrias 1,
1300-307, Lisbon, Portugal

Contact us
meetings@topra.org
+44 (0)20 7510 2560

#TOPRASym23

 

Exhibition / Sponsorship
Call +44 (0)20 7510 2573
or email erik@topra.org