This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for the ASEAN countries. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
The course can be completed at any pace, allowing the user to stop and start at their leisure.
Course Title: KPE’s Certificate Program in Drug Registration in ASEAN Countries
Course Objective: The objective of this course is to impart knowledge and understanding OF Drug Registration Procedure in ASEAN countries – Regulations, Registration procedure, Country specific Common Technical Document, ACTD guidelines and dossier preparation.
1. Orientation to practical understanding in the entire drug regulation, registration procedure, country specific common Technical Documents and ACTD guidelines and drug dossier preparations.
2. Simulation to real life Strategic planning in Drug Registration in ASEAN countries.
3. Access to Industry Data bank
4. Access to 1000’s of Pharmaceutical Case Studies
5. Attend Live Lectures of all different chapters / study content.
.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.
This course is divided into following modules
1. Overview of the ASEAN countries : Country Introduction
2. Introduction to Drug Regulation and Registration Process of the each countries
3. Introduction to ASEAN Common Technical Document
4. Comparison Study of ACTD, ICH CTD and e-CTD.
5. Obtaining International GMP Certification and maintaining the GMP continuum.
6. Drug Dossier Preparation : Interactive Session
7. Drug Registration Process – Time Line (country specific)
8. Registration of Innovative Pharmaceutical Products in ASEAN countries