InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$490 USD / 24500 INR.
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asean drug regulatory affairs course

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
Section 1Fundamental of Drug Discovery Development and Commercialization
Lecture 1Introduction to Pharmaceutical R&D | Drug Discovery Development Process
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Handling of orange book
Lecture 7Complete Response Letter | Key understanding | Management and Action Plan
Lecture 8Detailed understanding on expedited review
Lecture 9Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity
Lecture 10Clinical Trials Terminologies 
Lecture 11Handling of orange book
Lecture 12USFDA expedited programs
Lecture 13Practical Training on INDA, NDA, ANDA filing
Lecture 14505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 15Authorized Generics: Key Understanding
Lecture 16Exploratory IND Vs. Traditional IND
Lecture 17Patents Vs. exclusivity 
Lecture 18Orphan Drug Designation
Lecture 19Advance Learning on 505B2 Pathway
Lecture 20Chemistry, Manufacturing & Controls 
Lecture 21Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 22Review on Drug Discovery and Development 
Section 2Drug Regulation and Registration in ASEAN countries | Advance Strategic Planning
Lecture 23ASEAN Countries | Geographical Overview
Lecture 24ASEAN countries Statistics
Lecture 25ASEAN Region - Pharma Business
Lecture 26Prerequisite for export in ASEAN countries
Lecture 27The Pharmaceutical Inspection Co-operation Scheme
Lecture 28CPP Requirements for Drug Registration in ASEAN countries
Lecture 29Dossier Requirements - ACTD/CTD Acceptability
Lecture 30Pharmacopoeias Acceptability
Lecture 31Harmonization of Technical Guidelines 
Lecture 32Product Labelling
Lecture 33Post Approval Changes (Variations) requirements in ASEAN countries
Lecture 34Pharmacovigilance and Risk Management Plan (RMP)
Lecture 35Timeline of Drug Registration Approval
Lecture 36Drug Registration and Regulation in Brunei
Lecture 37Drug Registration and Regulation in Cambodia
Lecture 38ASEAN Drug Regulations : Comparison Study | Guidelines | Pharmaceutical products Regulatory Submissions | Pharmacopoeia Requirements | stability requirements | Pharmacovigilance | Product labeling | Drug variation information
Lecture 39Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management
Section 3Drug Regulation and Registration in ASEAN countries | Advance Strategic Planning
Lecture 40CMC - Funamental understanding
Lecture 41CMC Dossier & Compliance Management
Lecture 42Introduction to Common Technical Document (CTD)
Lecture 43Asean Common Technical Document (ACTD) 
Lecture 44Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 45Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 46Key Consideration for Drug Master File Preparation and Submission 
Lecture 47Practical Understanding on Drug Master File Preparation and Submission
Lecture 48Site Master File - Detailed Understanding 
Lecture 49DMF Completeness Assessment
Lecture 50Importance of effective dossier management
Lecture 51Discussion on 85 common deficiencies in CTD submission dossier
Lecture 52Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 53Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 54Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 55Comparsion of Drug Regulatory Requirements for various regions
Lecture 56Reference: Countries Classification based on climate and stability zone
Lecture 57Stability Zone Finder
Lecture 58Stability Study requirements for drug registration in ASEAN countries
Lecture 59Stability Studies : Case discussions
Lecture 60Accelerated and intermediate testing conditions
Lecture 61Long Term Stability Testing Requirements
Lecture 62Stability Study : Testing Frequency
Lecture 63Stability Study: Bracketing
Lecture 64Matrixing
Lecture 65Stability Study Protocol Development - Dosage form: Capsule
Lecture 66Stability Data Sheet
Lecture 67Dossier Stability Test
Section 4Plant Inspection and Certifications
Lecture 68Certification Pharmaceutical Companies / Plants 
Lecture 69Premises & Plant Layout Designing
Lecture 70Sanitation and Hygiene
Lecture 71Equipment Modules
Lecture 72Production Modules
Lecture 73Documentation
Lecture 74Quality Control
Lecture 75Product Complaint
Lecture 76Storage Module
Section 5Bioequivalence Study | PKPD Study
Lecture 77PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 78Bioequivalence Study | Study design | Different types of BE Studies
Lecture 79Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 80Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 81Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 82Bioequivalence Study - Discussion - Dissolution Testing
Lecture 83Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 6Variation Filing
Lecture 84Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 85Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.