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Wednesday, February 6 • 10:45 - 11:45
#S0801: The Impact of Innovation and Novel Pathways: The Role of the Regulator

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Component Type: Session

The International Coalition of Medicines Regulatory Authorities (ICMRA) will explore role of regulators in the current international landscape, including the impact of innovation and novel pathways. The session will be delivered by members of ICMRA who represent a number of leading regulators across Europe and beyond.

Chair

Ian Hudson

Speaker

Horizon Scanning: Methodologies and Best Practice
Tatsuya Kondo, MD, PhD

Leveraging Outcomes of Horizon Scanning
Agnès Saint-Raymond, MD

Novel Approaches to Licensing
John Patrick Stewart, MD

Overview of Projects
Lorraine Nolan, PhD


Speakers
avatar for Ian Hudson

Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)
Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Division... Read More →
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
avatar for Lorraine Nolan

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA)
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →
avatar for John Stewart

John Stewart

Director General, Health Canada
The Director General of the Therapeutic Products Directorate in the Health Products and Food Branch of Health Canada; overseeing the review and approval of drug and medical devices submissions seeking authorization to be sold on the Canadian market or in the context of clinical trials... Read More →

Wednesday February 6, 2019 10:45 - 11:45
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  08 Regional Updates, Session
  • Featured Topics Regulatory Science
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