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[DIAmond Session 1] New Challenges for Innovation - ICMRA Innovation Project -
Session Chair(s)
Rita Purcell, LLM
Deputy Chief Executive
Health Products Regulatory Authority (HPRA), Ireland
Guido Rasi, MD
Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology
Tor Vergata University of Rome, Italy
The International Coalition of Medicines Regulatory Authorities (ICMRA) is composed of executives from each participating national/regional regulatory agency, and discusses each agency’s experiences as well as strategies for resolving common issues. One of the top strategic priorities of ICMRA is the Innovation Project. This project is composed of three work streams, which aims to 1) investigate and research each agency’s horizon scanning methodology, 2) share and leverage outcomes of horizon scanning, and 3) discuss the latest trends in novel pathways to licensing. In this session, the leads of each work stream will present the latest findings and discusions.
Speaker(s)
The Report form WS1; Analysis of Global Best Practice in Horizon Scanning Methodologies
Tatsuya Kondo, MD, PhD
SH Medical Excellence JAPAN, Japan
President
The Report from WS2; Leveraging from Outcomes of Horizon Scanning
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
The Report from WS3; Novel Approaches to Licensing
Pierre Sabourin, MBA
Health Canada, Canada
Assistant Deputy Minister, Health Products and Food Branch
Nikolai Constantin Brun, MD
Danish Medicines Agency, Denmark
Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics
John Graham, PhD, MBA
FDA, United States
Director, Office of Research Center for Veterinary Medicine