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Monday, June 24 • 11:00am - 12:00pm
#117: International Regulatory Convergence

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

Discuss how regulators approach relative effectiveness in various jurisdictions. The opportunity arises at a time when the EU is discussing joint evaluations and legal framework. Canada is also working on interactions with the bodies responsible for this evaluation. Japan has initiated a pilot on relative effectiveness comparison.
We intend to show how international regulatory authorities could cooperate and share experience to ensure global coordination of data, studies, and evaluation in the context of global development.

Learning Objectives

Discuss how the main regulatory Agencies collaborate and work with those involved in relative effectiveness and added therapeutic value of medicines; Identify the common criteria used and determine when independence should be maintained; Examine specific issues with Advanced Therapies/regenerative medicines and added value; Describe the importance of collaboration at the international level

Chair

Agnès Saint-Raymond, DrMed, MD

Speaker

Panelist
Guido Rasi, MD

Panelist
Pierre Sabourin, MBA

Panelist
Brian O'Rourke, PharmD

Panelist
Giovanni Tafuri, PhD, MS

Panelist
Katsuaki Ura



Speakers
avatar for Brian O'Rourke

Brian O'Rourke

President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
Dr. Brian O’Rourke is the President and Chief Executive Officer of CADTH. He joined CADTH in January of 2009 following a distinguished career as a Pharmacist and Health Service Executive with the Canadian military. With over 30 years of experience in health care, Brian actively... Read More →
avatar for Guido Rasi

Guido Rasi

Executive Director, European Medicines Agency (EMA)
Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →
avatar for Pierre Sabourin

Pierre Sabourin

Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory... 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 Giovanni Tafuri

Giovanni Tafuri

Senior Scientific Officer, EUnetHTA
Giovanni Tafuri is the Senior Scientific Officer of the European Network for Health Technology Assessment (EUnetHTA) at the EUnetHTA Secretariat in the Netherlands. Prior to his appointment, he worked at both the HTA and the regulatory department of the Italian Medicines Agency (2006-2018... Read More →
avatar for Brian O'Rourke

Brian O'Rourke

President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
Dr. Brian O’Rourke is the President and Chief Executive Officer of CADTH. He joined CADTH in January of 2009 following a distinguished career as a Pharmacist and Health Service Executive with the Canadian military. With over 30 years of experience in health care, Brian actively... Read More →
KU

Katsuaki Ura

Deputy Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW)
Mr. Katsuaki Ura is currently Deputy Director, Office of International Regulatory Affairs, Pharmaceuticals Safety and Environmental Health Bureau, Ministry if Health, Labour and Welfare (MHLW), Japan since April 2018. He is engaged in international regulatory harmonisation through... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA