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Wednesday, June 19 • 8:00am - 9:00am
#310: WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-631-L04-P; CME 1.00; RN 1.00

This session aims to delve into WHO's pivotal role in the evolving landscape of global regulatory excellence. The discussion will revolve around the transformative impact of WHO-listed Authorities on medical product regulation, emphasizing regulatory reliance as a holistic approach to enhance efficiency and accessibility. Additionally, the session will address the pressing issue of substandard/falsified medical products and their potential threats to global health.

Learning Objectives

Describe the significance of WHO-listed Authorities in shaping the future of medical product regulation; Examine the concept of regulatory reliance as a key strategy to enhance access and efficiency in global regulatory practices; Discuss the critical role of regulatory excellence in safeguarding public health against the threats posed by substandard/falsified medical products.

Chair

Samvel Azatyan, MD, PhD

Speaker

Elevating Regulatory Reliance: The Strategic Impact of WHO-Listed Authorities in Transforming Global Regulatory Landscapes
Hiiti Sillo, MSc, RPh

Securing Supply Chains: A Global Imperative
Rutendo Kuwana, RPh

EMA Update
Emer Cooke, MBA, MSc

Industry Update
Janis Bernat, MSc

Moderator for Panel Discussion and Q&A
Marion Laumonier, MSc


Speakers
avatar for Samvel Azatyan

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
avatar for Janis Bernat

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →
avatar for Emer Cooke

Emer Cooke

Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
RK

Rutendo Kuwana

Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland
Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →
avatar for Marion Laumonier

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland
Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →
avatar for Hiiti Sillo

Hiiti Sillo

Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland
Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO department of Regulation and Prequalification. Until August 2021, he was the Team Lead, Regulatory Systems Strengthening (RSS), Regulation and Safety Unit. Before joining WHO in January 2018, he was the Director General... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum