InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 USD / 18500 INR.
Buy NowBook Now
Loading
free resources at royed training
Loading
china drug regulatory affairs

Introduction

Course Type

Course Duration

Feature

Eligibility

Who should attend

Certification

Course Deliverable

Related Courses

About RA

Online course in china DRA

This self paced online certification course on Drug Registration and Regulation in China provides deep insight on the drug registration process in China. How pharmaceuticals and biopahrmaceuticals should be registered in China. Detailed understanding is provided new and updated pharmaceutical regulatory system (post 2015) of China. Hence, this China drug regulatory affairs course is designed to provide extensive training for professionals who are handling drug registration and marketing of pharmaceutical and bio-pharmaceuticals for China.

In 2015, China’s pharmaceutical sector is undergone with the significant regulatory reform. Therefore, regulatory approval process has changed a lot. The regulatory reform had taken place keeping easy of marketing authorization. While all effort is provided to realign the regulatory pathway with developed market like US and EU.

So, focus of the course will be on strategic pathway for registering new drugs, generic drugs, and also imported drugs which are not manufactured in china. Moreover, special emphasis is given on advance drug dossier development training. So, that one can create the submission dossier effectively.

The course can be completed at own pace. Hence it allows the user to stop and start at their leisure.

Course Title: Advance Certification Course in Drug Registration and Regulation in China

Course Code: RYD-060

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

1 Month

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

  • 24×7 Online Access. Therefore, access the course anytime from anywhere across globe.
  • Students can download the course materials from dashboard. Hence, it helps them to study offline even after completion of the course.
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page. 
  • Moreover, final examination is online. Hence student can attend the final examination own convenient date and time. 

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

  • Those who want to know about the China Pharmaceutical Market, Regulation.
  • One want to enhance knowledge about the China’s recent regulatory reform.
  • 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 China.

 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.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

China pharma market is approximetly US $ 150 billion and growing at very rapid pace. This rapid growth is because of China’s rapid ageing of the population and rising incomes will lead to a surge in demand for medicines and quality healthcare services. Market predicts a huge growth for Chinese pharmaceutical market. It may reach US $ 372.4bn in 2027 with a CAGR of 9%. But there is a rising concern over the safety and efficacy.

However, there are lot of regulatory changes as far as the the drug registration and regulation in China. So, the major objective of the regulatory changes to maintain safety and efficacy of the drugs and bio molecules. And The regulatory reform had taken place keeping easy of marketing authorization. Above all, this reform will help to align the regulatory pathway with developed market like US and EU. Hence, this will be easier and easily manageable.

About regulatory affairs job>> Learn here

About China Drug Regulatory Agency >> Learn more

 

Section 1Fundamental Understanding on Drug Regulation
Lecture 1Understanding on Drug Discovery Development Process to Commercialization
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Biological Licensing Application (BLA) 
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 9USFDA expedited programs
Lecture 10Clinical Trials
Lecture 11Clinical Trial Protocol Writing
Lecture 12Chemistry, Manufacturing & Controls 
Lecture 13Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 14Chemistry, Manufacturing & Controls 
Section 2China Drug Registration Process | Strategic Planning for effective Submission
Lecture 15Drug Registration and Regulation in China | New Reform | Regulatory Classification | Strategic Planning for each class of drugs | Dossier Submission and Approval Process
Lecture 16New Update: NMPA's the Drug Registration Regulation (DRR) and the Drug Manufacturing Regulation (DMR) update on July, 2020
Lecture 17Common Technical Document (CTD)
Lecture 18Advance Practical Training on Dossier Preparation
Lecture 19CMC Dossier & Compliance Management
Lecture 20Importance of effective dossier management
Lecture 21Discussion on 85 common deficiency in CTD submission dossier
Lecture 22Electronic Common Technical Document (ECTD)
Section 3GMP | Plant Audit | Inspection and Certification
Lecture 23Premises & Plant Layout Designing
Lecture 24Sanitation and Hygiene
Lecture 25Equipment Modules
Lecture 26Production Modules
Lecture 27Documentation
Lecture 28Quality Control
Lecture 29Product Complaint
Lecture 30Storage Module
Lecture 31Plant Inspection | Handling Plant Audit
Lecture 32Data Integrity
Section 4DMF and SMF
Lecture 33Key Consideration for Drug Master File Preparation and Submission 
Lecture 34Practical Understanding on Drug Master File Preparation and Submission
Lecture 35Associated Learning: Site Master File - Detailed Understanding 
Lecture 36DMF Completeness Assessment
Lecture 37Drug Master File - Fees
Lecture 38Drug Master File - Global Perspective [Across Different Regions]
Section 5Stability Study
Lecture 39Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 40Climate Zone
Lecture 41Stability Zone Finder
Lecture 42Stability Studies : Case discussions
Lecture 43Stability Data for Zone IV countries
Lecture 44Accelerated and intermediate testing conditions
Lecture 45Long Term Stability Testing Requirements
Lecture 46Stability Study Protocol Development - Dosage form: Capsule
Lecture 47Stability Data Sheet
Lecture 48Dossier Stability Test
Lecture 49Testing Frequency
Lecture 50Bracketing
Lecture 51Matrixing
Section 6PK-PD | BA-BE Study
Lecture 52PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 53Bioequivalence Study | Study design | Different types of BE Studies
Lecture 54Bioequivalence 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 55Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 56Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 57Bioequivalence Study - Discussion - Dissolution Testing
Lecture 58Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 7Marketing Authorization Variation Management
Lecture 59Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 60Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline