InstructorRoyed Training
TypeOnline Course
Student Enrolled2
Price$490 USD/ 27500 INR.
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japan drug regulatory affairs course


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Japan drug regulatory affairs

Japan drug regulatory affairs course provides training on marketing authorization process and strategic planning in Japan. The course provide detail training on drug Registration Procedure in Japan. It covers recent regulations, marketing authorization procedure, country specific Common Technical Documents, guidelines and dossier preparation. Moreover course focus on the regulatory affairs strategic planning for marketing authorization for different class of pharmaceutical, biopharmaceutical in Japan. Hence, this course is vastly useful for those who want to know or already working in regulatory affairs. This course will help them to enhance competency to handle Japan Marketing Authorization Application effectively.

The course is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in Japan. Moreover the course identifies the key trends in regulatory, reimbursement landscape and healthcare infrastructure of Japan. Most importantly, the course provides valuable insights advance regulatory strategic planning for successful product registration in Japan.

The course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place, allowing the user to stop and start at their leisure.

Course Code: RYD-075

Course Title: Advance Certification in Drug Registration & Regulation in Japan

Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.

1 Month

Features of Japan Drug Regulatory Affairs Course

This Japan Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the Japan pharmaceutical market. Therefore, 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.

Learning Mode

  • The course is self paced. Hence, course can be accessed 24×7, anytime, anywhere across the globe.
  • Course is accessible 24×7 from any smart phone, desktop, laptop etc.

Key features of the course

  • Orientation to practical understanding in the entire drug regulation, registration procedure of Japan. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations. Moreover, course explains various marketing authorization strategic pathways. This helps to enhance the regulatory strategic decision making skill.
  • The course extensively covers marketing authorization requirements for full application, verification pathway and abridged pathway. Hence, the course will nurture the regulatory strategic decision making skills.
  • Moreover, this training covers variations and renewals of marketing authorization specific to pharmaceutical registration in Japan.
  • This training program has advance sessions on CMC preparation, Stability Study, Drug Master File Preparation, Site Master File Preparation, Good Manufacturing Practices modules.
  • 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.

Graduation in any discipline. Even the final year student can join the course.

  • Freshers and beginners. Those who want to know about the Japan Pharmaceutical Market, Regulation.
  • Drug regulatory affairs professionals. Who want to enhance knowledge about the Japan regulatory affairs.
  • Business Development, Regulatory Affairs, IPR, strategic management professionals who want to have the detailed understand strategic planning process for registration and regulation of the pharmaceuticals in Japan.

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

  1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also eligible to receive the course study modules, which you can download by login to your course page.

Few of the similar courses

Japan Pharmaceutical Market

Japan’s pharmaceutical market value is set to grow at a tepid Compound Annual Growth Rate (CAGR) of 1.3% from $72.8 billion in 2013 to reach $79.8 billion by 2020.

But there are certain challenging factors which companies need to deal with. One of the most important challenge is Japanese government is now promoting the generic drugs. Moreover, there is introduction of biennial pricing review system. Therefore, it is causing slow growth in Japanese pharma market. The depreciation of the yen against the dollar will be limiting factors in what is the second largest mature pharmaceutical market in the world by value.

About Japan Drug Regulatory Affairs Course

In this Japan drug regulatory affairs course, focus is on learning the fundamental to advance learning regarding drug discovery, development to commercialization process. Secondly, course is designed to provide comprehensive training on marketing authorization process for pharmaceutical, biopharmaceutical. Above all, course provide extensive training on drug authorization dossier preparation. In addition, course provide access to case simulations and case studies pertaining to drug registration in Japan. Certainly, this help all students to acquire practical understanding regarding marketing authorization process in Japan.

About regulatory affairs job>> Learn here

Section 1R&D Fundamental - Drug Discovery to Commercialization
Lecture 1Understanding on Drug Discovery Development Process to Commercialization
Lecture 2Investigational New Drug and Investigational New Drug Application
Lecture 3Understanding on New Drug and New Drug Application
Lecture 4Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA) 
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8Handling of orange book
Lecture 9Expedited programs
Lecture 10Clinical Trial Fundamental Understanding
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 12Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets 
Section 2Japan Marketing Authorization Process | PMDA strategic Review | MA strategic Planning | Variation | Case Studies
Lecture 13Introduction to Japan Drug Regulatory Affairs 
Lecture 14Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 15Drug Approval System | GCP | PMDA requirements 
Lecture 16New Drug Application | Requirements | Review Process
Lecture 17Generic Drug Application Review and Approval 
Lecture 18Common Technical Document (CTD)
Lecture 19Chemistry, Manufacturing & Controls 
Lecture 20Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 21Preformulation Study in Drug Development 
Lecture 22Regulatory Requirements for Preformulation Study 
Lecture 23Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies  
Lecture 24Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 25Types and Timing of Non-clinical Studies
Lecture 26ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 27ICH Q2 : Analytical Validation 
Lecture 28ICH Q3 : Impurities
Lecture 29Rest of ICH Q Family Guidelines
Lecture 30CMC Dossier & Compliance Management
Lecture 31Electronic Common Technical Document (ECTD)
Lecture 32Marketing Authorization Process for registration of pharmaceutical in Japan
Lecture 33API Registration in Japan | Step By Step Process
Lecture 34Generic Registration | Patent - Patent Term Extension | Exclusivity | Re-examination System | Pediatric Designation |  Patent Term Extension Case Studies
Lecture 35Priority Review Application | Criteria | Review Process | Timeline
Lecture 36Orphan Drug Designation in Japan
Lecture 37Japan DMF System | MF filing Process | Key points 
Lecture 38Key Consideration for Drug Master File Preparation and Submission 
Lecture 39Practical Understanding on Drug Master File Preparation and Submission
Lecture 40Strategic Approval Pathway - Formulation Approval Quoting MF
Lecture 41SAKIGAKE designation 
Section 3GMP Management and Plant Inspection Handling
Lecture 42Premises & Plant Layout Designing
Lecture 43Sanitation and Hygiene
Lecture 44Equipment
Lecture 45Production Module
Lecture 46Documentation
Lecture 47Quality Control
Lecture 48Handling of Product Complaint
Lecture 49Storage Module
Lecture 50Handling and Management of plan inspection
Lecture 51Data Integrity issues in Pharmaceutical Industry | Management from regulatory perspective
Section 4Stability Study
Lecture 52Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 53Climatic Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 54Stability Zone Finder
Lecture 55Stability Studies Case Discussions
Lecture 56Case Study: Managing Stability Study for Zone IV countries
Lecture 57Accelerated and intermediate testing conditions
Lecture 58Long Term Stability Testing Requirements
Lecture 59Testing Frequency
Lecture 60Bracketing
Lecture 61Matrixing
Section 5Bioequivalence Study
Lecture 62PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 63Bioequivalence Study | Study design | Different types of BE Studies
Lecture 64Bioequivalence 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 65Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 66Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 67Bioequivalence Study - Discussion - Dissolution Testing
Lecture 68Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 6Variation Management
Lecture 69Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 70Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Lecture 71Japan Variation Management Process | Types | Steps involved in Variation Management | Strategic Planning