InstructorRoyed Training
TypeOnline Course
Price$490 USD/ 27500 INR.
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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 1Fundamental Sessions
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
Section 2Japan Marketing Authorization Process | PMDA strategic Review | MA strategic Planning | Variation | Case Studies
Lecture 11Introduction to Japan Drug Regulatory Affairs 
Lecture 12Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval 
Lecture 13Drug Approval System | GCP | PMDA requirements 
Lecture 14Advance Practical Training on Dossier Preparation focusing on drug registration in Saudi Arabia
Lecture 15CMC Dossier & Compliance Management
Lecture 16Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 17Documentation Required for Saudi Arabia | Comparing Documentation Required for Saudi Arabia against other GCC countries
Lecture 18Key Consideration for Drug Master File Preparation and Submission 
Lecture 19Practical Training on preparing DMF and SMF
Lecture 20Site Master File
Lecture 21Importance of effective dossier management
Lecture 22Discussion on 85 common deficiency in CTD submission dossier
Lecture 23Electronic Common Technical Document (ECTD) Training
Section 3GMP Management and Plant Inspection Handling
Lecture 24Premises & Plant Layout Designing
Lecture 25Sanitation and Hygiene
Lecture 26Equipment
Lecture 27Production Module
Lecture 28Documentation
Lecture 29Quality Control
Lecture 30Handling of Product Complaint
Lecture 31Storage Module
Lecture 32Handling and Management of plan inspection
Lecture 33Data Integrity issues in Pharmaceutical Industry | Management from regulatory perspective
Section 4Certification Examination