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
Head of Scientific Evidence Generation Department
EMA, the Netherlands
HM3: A spotlight on to the future - Fireside Chat | 23 October 2023
Director Regulatory Affairs
PTC Therapeutics International Limited, Switzerland
Session Leader
Sabine Haubenreisser
Principal Scientific Administrator - Stakeholders and Communication
EMA, the Netherlands
Chief Medical Officer
European Medicines Agency (EMA), the Netherlands
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
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
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
Head of EU Regulatory Science and EMA Liaison
Roche, Switzerland
Senior Scientific Specialist
EMA, the Netherlands
Director Supervision
Läkemedelsverket/Medical Products Agency (MPA), Sweden
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
Scientific Administrator
EMA, the Netherlands
Speaker
Dr. Kimberly Smith
Medical Officer
U.S. Food and Drug Administration (FDA), USA
Head of the Health Technology Assessment (HTA), Pricing and Reimbursement Division (DATS)
Infarmed, Portugal
HM7: Paediatric Investigational Plans | 25 October 2023
Head of Scientific Office
Austrian Medicines and Medical Devices Agency (MEA), Austria
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
Senior Scientific Specialist
EMA, the Netherlands
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
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
Patient Relations
EMA, the Netherlands
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
Principal Regulatory Affairs Consultant
Ariello, Ireland
Senior Director, Regulatory Affairs
Boyds, UK
Executive Director, Life Sciences
TransPerfect, France
Speaker
Maria Isabel Vieira
Non-clinical Farmacotoxicologist Assessor
Infarmed, Portugal