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Tuesday, June 28 • 8:00am - 9:45am
#201: International Regulatory Convergence, Collaboration, and Cooperation

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.75; IACET 1.75; RN 1.75

Join senior leadership from international regulatory authorities to hear the latest on multi- and bilateral initiatives that avoid duplication and increase mutual reliance, their strategic governance, and their impact on industry.

Part 1 of this session will see the heads of three regulatory agencies provide updates on the challenges facing them as global regulators, both domestic and within the framework of international cooperative initiatives.

In Part 2, the panel will be joined by additional heads of regulatory authorities with leading roles in the International Coalition of Medicines Regulatory Authorities (ICMRA) and will provide an overview of the developing role of ICMRA and initiatives aimed at facilitating interactions, coordination, and convergence. It will also address ICMRA's current status of strategic collaboration in areas such as pharmacovigilance, crisis management and supply chain integrity (GMP and traceability).

The combined panel will look at existing initiatives to avoid duplication and increase mutual reliance between regulators, the need for strategic governance of these initiatives and their impact on industry and other stakeholder.

Learning Objectives

Identify the current framework of bilateral and multilateral international cooperation initiatives; Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.

Chair

Emer Cooke, MBA

Speaker

Panelist
Emer Cooke, MBA

Panelist
Robert M. Califf, MD

Panelist
Tatsuya Kondo, MD, PhD

Panelist
Anil Arora

Panelist
Lorraine Nolan, PhD

Panelist
Jonathan Mogford

Panelist
John Skerritt, PhD

Panelist
Jarbas Barbosa, MD, PhD



Chair
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation Sector. She currently is the Head of International Affairs (formerly International Cooperation Sector)

Speakers
avatar for Anil Arora

Anil Arora

Chair of the ICMRA; Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Mr. Arora has a breadth of experience in the private and public sectors. He has worked internationally-bilaterally, as well as with the UN and the OECD, including leading a multi-year program with the National Bureau of Statistics in the modernization of China’s statistical system and infrastructure. Mr. Arora has completed the Canada School of Public Service’s Living Leadership and Advanced Leadership Program, the Public Sector Management... Read More →
avatar for Jarbas Barbosa

Jarbas Barbosa

ICMRA Project Lead; Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)
Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems. In July 2015, he was nominated Director President of the Brazilian Health Regulatory Agency – Anvisa.
avatar for Robert Califf

Robert Califf

Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation Sector. She currently is the Head of International Affairs (formerly International Cooperation Sector)
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is the Chief Executive of Pharmaceuticals and Medical Devices Agency since 2008. Before taking the current position, he spent most of his career as a neurosurgeon after he graduated from the University of Tokyo in 1968. He also has wide-ranging experience overseas, such as at Max-Planck Institute in Germany and at China-Japan Friendship Hospital in Beijing.
JM

Jonathan Mogford

Director of Policy, Medicines and Healthcare products Regulatory Agency (MHRA),
avatar for Lorraine Nolan

Lorraine Nolan

Vice-Chair of the ICMRA; 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 the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines... Read More →
avatar for John Skerritt

John Skerritt

ICMRA Project Lead; Deputy Secretary for Health Products Regulation, Department of Health
Dr John Skerritt joined the Commonwealth Department of Health in May 2012 and is currently a Deputy Secretary. He was formerly the National Manager, TGA, until his role was expanded and that position was absorbed into his current role. He also has responsibility for the Department’s Office of Drug Control which is responsible for developing the new medicinal cannabis regulatory scheme.


Tuesday June 28, 2016 8:00am - 9:45am
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA