Introduction
Course Type
Course Duration
Feature
Eligibility
Who should attend
Certification
Course Deliverable
Related Courses
About RA
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.Â
- Moreover, final examination is online. Hence student can attend the final examination own convenient date and time.Â
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.
- Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
- You will also eligible to receive the course study modules, which you can download by login to your course page.
- Drug Regulatory Affairs
- Latam drug regulatory affairs
- European Drug Regulatory Affairs
- GCC Drug Regulatory AffairsÂ
- UAE drug registration and approval
- Drug Registration and Regulation in China
- US (FDA) pharmaceutical and biopharmaceutical regulation
- Drug discovery development to commercialization
- Biopharmaceutical Regulatory Affairs
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
