AEFI – TRAINING ON DRUG REGISTRATION IN SOUTHEAST ASIA
Fecha: Lunes, 20 de enero de 2025
Horario: de 9.00 a 13.00h
Formato: Online
Lugar: Plataforma Zoom
OBJETIVO DEL CURSO
The objective of this training on drug registration in Southeast Asia is to provide participants with an understanding of the regulatory frameworks, procedures, and challenges involved in the drug registration process across the region focusing on: Vietnam, Thailand, Singapore, Taiwan, Malaysia, Philippines, Indonesia.
A QUIÉN VA DIRIGIDO
This training is aimed at personnel involved in drug registration tasks in Southeast Asia or tasks related to registration such as Registration managers and technicians, Registration Consultants, Technical Management, Medical Department, Product Managers, Clinical Research and R&D Teams.
COORDINADO POR
BÁRBARA FERRER LLOVERA. Coordinadora Grupo de Trabajo Registros Internacionales. AEFI Sección Catalana
PONENTES
VIJAY S. MARDANE. Associate Director – Regulatory CMC. INova Pharmaceuticals Pte Limited. Singapore
AGENDA
| 09:00 – 09:15 | RECEPTION AND PRESENTATION OF THE TRAINING |
| 09:15 – 09:45 | INTRODUCTION TO ASEAN REGULATORY LANDSCAPE1.1 Brief summary on Regulatory authorities of each country. 1.2 Summary of Regulatory registration pathways in each country. 1.3 Mutual Recognition aspects on GMP for Medicinal product submission. |
| 09:45 – 10:15 | CMC DOSSIER REQUIREMENTS (PART I)2.1 Asean vs CTD dossier |
| 10:15 – 10:30 | BREAK |
| 10:30 – 12:45 | CMC DOSSIER REQUIREMENTS (PART II)2.2. Asean common technical requirements in detail 2.2.1: Process validation requirements 2.2.2: Stability studies requirement 2.2.3: Drug substance DMF/CEP aspects in Asean market 2.2.4: Analytical method validations Requirement |
| 12:45 – 13:00 | QUESTIONS AND ANSWERS |
| 13:00 | CLOSING OF THE TRAINING |
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Coste y Proceso de inscripción
INSCRIPCIÓN
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PRECIO
Socios AMIFE y AEFI: 160€
No socios: 280€
Aforo limitado.