Regulatory Workshop

GBC 8

Regulatory Workshop

09:00 ~ 12:00 GB II 5F

Summary
WHO has announced innovative changes in the biopharmaceuticals regulations. At the GBC 2018, we explore evolving regulatory directions, and global regulators will deliver a presentation on their organization and current states of regulations.
Closed one-on-one meetings with a regulator are held only for pre-registrations.
Date
June 29(Fri), 09:00 ~ 12:00
Venue
GB II 5F Venue Guide

Schedule

Time Title Presentation File
Regulatory Workshop
[WHO Special]
09:00~09:05(5')

Opening & Congratulatory Address

Young-ok Kim / Director General, MFDS

-
09:05~09:35(30')

WHO policy and methodology on benchmarking of National Regulatory Authorities

Alireza Khadem Broojerdi / WHO

09:35~10:05(30')

Regional perspectives and lessons on WHO NRA benchmarking

Jinho Shin / WHO

10:05~10:35(30')

COFEPRIS Global: Acknowledgements PIC/S and PAHO

Marielle Pascual Quintero / COFEPRIS

10:35~11:00(25')

Q & A / Discussion

-
11:00~11:20(20')

Coffee Break

-
Poster Presentation
11:20~12:50(90')

Current situation in Chile regarding biological products

Eugenia Cabrera / Evaluator of quality dossier to sanitary register of biological products, Public Health Institute of Chile

The Malaysian Perspective on Biologics Regulation

Noraisyah binti Mohd Sani / Head, National Pharmaceutical Regulatory Agency

Vaccines and biotechnological products and the Regulatory Process

Marielle Pascual Quintero / General Director of Sanitary Authorization Commission, COFEPRIS

1. The Regulation of Therapeutic Products in Singapore
2. Singapore’s Regulatory Trends and Pharmaceutical Landscape

Sek Wei(Freddie) Foo / Regulatory Consultant, Health Sciences Authority, Singapore

Biologicals Products in Peru: A Regulatory Overview

Nathaly Vila Peña / Technical Evaluator, General Directorate of Medicine, Supplies and Drugs (DIGEMID) - Ministry of Health (MINSA)

Egyptian Drug Authority (EDA)

Engy el Hosary / Lead Biological Products Inspector, Central Administration for Pharmaceutical Affairs