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Tuesday, June 27 • 8:30am - 9:30am
#136: WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-534-L04-P; CME 1.00; RN 1.00

The new WHO Listed Authorities (WLAs) framework offers a transparent system for NRA to decide which NRA they can rely upon. An update will be given by WHO and perspectives from some of the newly designated WLAs will highlight the main principles and expected global benefits of the scheme.

Recent years and the regulators response to the COVID-19 pandemic have shown that reliance is key for a more efficient global regulatory oversight of medical products. Recent updates will be given on the WHO Good Reliance Practices implementation along with concrete examples of innovative pilots and lessons learned on reliance.

The ultimate focus of WHO activities is the country impact as highlighted by Dr Tedros, WHO Director, for his second term. Regulatory systems strengthening activities have a key role to play in terms of helping countries identifying and addressing gaps using the benchmarking tool and building capacity towards achieving a more stable maturity level (ML3 goal of WHA Resolution 67.20). Regional efforts also play an important part for capacity building and reaching harmonization and convergence of regulatory requirements.

Learning Objectives

Discuss regulatory systems strengthening activities which have a key role to play in terms of helping countries identify and address gaps using the benchmarking tool and build capacity to achieve a more stable maturity level; Describe regional efforts that play an important part for capacity building and reaching harmonization and convergence of regulatory requirements.

Chair

Samvel Azatyan, MD, PhD

Speaker

Keynote Presentation: Coordinated Efforts for Regulatory System Strengthening, Reliance and WLA
Rogerio PAULO Gaspar, PharmD

Updates on the Framework for WHO Listed Authorities (WLAs): A Transparent Reference System for Reliance
Hiiti Sillo, MPharm, RPh

Panelist: The Road to WLA – a NRA Journey
Cheng Leng Chan, PharmD

Panelist: WLA Concept - Benefits to Accelerate Access to Quality Medicine
Janis Bernat, MSc

Panel Discussion and Q&A from the Audience
Samvel Azatyan, MD, PhD


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 Cheng Leng Chan

Cheng Leng Chan

Group Director, Health Products Regulation Group, Health Sciences Authority (HSA), Singapore
Associate Professor Chan Cheng Leng is the Group Director, Health Products Regulation Group, Health Sciences Authority (HSA), Singapore. She has extensive and deep work experience in the area of health products regulation and safety monitoring. She plays a leading role in developing... Read More →
avatar for Rogerio Gaspar

Rogerio Gaspar

Director, Regulation and Prequalification Department, World Health Organization (WHO), Switzerland
Dr. Rogério Gaspar from Portugal joined WHO January 6, 2021, as the Director of Regulation and Prequalification Department. He obtained his PhD in Pharmaceutical Sciences from the Catholic University of Louvain Belgium in 1991, after a graduation as pharmacist from the University... 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 →

Tuesday June 27, 2023 8:30am - 9:30am EDT
Room 205 A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session