InstructorRoyed Training
TypeOnline Course
Price$390 USD / 18500 INR.
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ASEAN drug regulatory affairs

ASEAN drug regulatory affairs

Introduction

Course Type

Course Duration

who should attend

Eligibility

Feature

Certification

Content

Related Courses

The objective of ASEAN Drug Regulatory Affairs course is to provide training on Drug Regulatory Affairs and drug registration process in ASEAN countries.

ASEAN regulatory affairs course covers recent pharmaceutical regulations, drug approval procedure, country specific Common Technical Documents requirement. Moreover, comprehensive idea is provided how to prepare drug dossier as per ACTD format. Above all, course briefs on strategic planning for registration of pharmaceutical, biopharmaceutical in ASEAN countries.

This online course utilizes interactive learning tools to guide each participant through to understand of the ASEAN regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding of each specific countries regulations and registration norms. Importantly, course also provide specific requirements and structure of the registration dossier specific to each countries. As all the countries do not follow ACTD guideline. Rather, they suggest the changes in standard guideline. Hence, it will be important to understand guideline of each specific ASEAN countries.

The course provides practical based and interactive for effective understanding. Importantly, the course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions. As a result, it helps to build the competency of the participants.

Course Title: RYD-040
Course Code: Advance Certification in ASEAN Drug Regulatory Affairs

Online distance learning course. Hence, course can be accessed 24×7, across anywhere.

1 Month

Who should attend?

  • Regulatory Affairs professionals who are seeking to improve their skills in the ASEAN Drug Regulatory environment.
  • Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others).
  • Regulatory Affairs, Registration and Documentation assistants/officers/managers.
  • Above all, this course is ideal for the business development managers working in pharmaceutical company, who are handling pharmaceutical business in European Union.

Any body who wants to acquire ASEAN drug regulatory affairs competency should attend the course.

This ASEAN Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the ASEAN pharmaceutical market. Moreover, this online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.

Key features of the course

  • Orientation to practical understanding in the entire drug regulation, registration procedure of each ASEAN countries. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations.
  • The course is self paced. Hence, course can be accessed 24×7, anytime, anywhere across the globe.
  • Moreover, students can download the course material hand out by login to dashboard. Hence, it helps them to study offline even after completion of the course.
  • Final examination is online. Hence, student can attend the final certification examination at own convenient date and time.

 Certificate will be provided at the end of the successful completion of the course

Course Content

The objective of this course is to impart knowledge and understanding of Drug Registration Procedure in ASEAN countries. Hence, the core focus will be on learning Drug Regulations, Drug Registration procedure, Country specific Common Technical Document, ACTD guidelines and dossier preparation.

This course is divided into following modules

  • Overview of the ASEAN countries : Country Introduction
  • Introduction to Drug Regulation and Registration Process of the each countries
  • Introduction to ASEAN Common Technical Document
  • Comparison Study of ACTD, ICH CTD and e-CTD.
  • Obtaining International GMP Certification and maintaining the GMP continuum.
  • Drug Dossier Preparation : Interactive Session
  • Drug Registration Process – Time Line (country specific)
  • Registration of Innovative Pharmaceutical Products in ASEAN countries