Navigating the regulatory landscape for pharmaceutical registration in China is complex and challenging, with stringent requirements, procedures, and timelines to consider. To help pharmaceutical manufacturers maximize their chances of success and gain market access in China, this course provides valuable insights and guidance on the registration process.
The course covers the regulatory framework, procedures, timelines, and requirements, as well as registration pathways, strategies, and a checklist of dossier requirements for successful registration. Attendees will gain an in-depth understanding of the registration process and associated costs and challenges, enabling them to develop a comprehensive strategy for successfully registering their products in this lucrative market. The course also includes a comprehensive guide to regulatory compliance, covering key considerations for GMP, GCP, and pharmacovigilance in China, essential for avoiding regulatory pitfalls and potential market access issues.
Attendees will have understanding of China’s pharmaceutical registration process and be better equipped for successful market access in this growing market.
Key points of the training
- Understand the regulatory framework for pharmaceutical registration in China and the key regulatory bodies involved
- Gain a comprehensive overview of the different registration pathways and strategies available in China
- Understand the procedures, timelines, and requirements involved in the pharmaceutical registration process in China
- Learn about the documentation requirements for successful registration, including the dossier requirements and checklist
- Gain insights into the costs associated with pharmaceutical registration in China and how to develop a comprehensive strategy for success
- Understand the differences between the Chinese and Western regulatory frameworks, including the comparison with EU and US regulations
- Learn about the potential pitfalls and challenges in the registration process and how to navigate them successfully
- Gain knowledge about the key considerations for imported drugs registration in China to ensure regulatory compliance and market access
- Have the opportunity to ask questions and get expert advice from experienced professionals in the field
Struttura del corso
09:30– 12:30 SESSIONE CORSO
China Pharmaceutical Regulatory Framework: Gain an understanding of the regulatory landscape in China and the latest regulatory developments.
- Drug lifecycle management
- Competent authorities
- China medical insurance system
China Drug Registration Overview: Learn about the application types, drug classification, process, timelines and costs involved in the drug registration in China.
- Basic concept
- Registration process
- Registration timeline
- Registration cost
Imported Drug Registration: Gain insights into imported drug registration process, overseas data compatibility, data gap challenges and learn from the case study of industry experts
- Registration process
- Product analysis-overseas data acceptance
- Data gap analysis-regulatory challenge
- Case study
Post-marketing Surveillance: Learn about local requirements and the to-do-list after market approval in China and be ready in advance
- pharmacovigilance (ADR Monitoring)
- Traceability system
- Product recall
Tips & Pitfalls: Learn about the common tips and pitfalls from practical experience for successful drug registration in China.
30 min Q&A: Engage with our panel of experts and get your questions answered in real-time.
This course is designed for professionals who are involved in the pharmaceutical industry. For professionals includes:
- R&D Professionals
- Regulatory Affairs
- Quality Assurance/Control Professionals
- Regulatory Compliance Professionals
- Project Management Professionals
- Government Regulators and Officials
- Contract Research Organizations (CROs)
- Distributors and Importers
- Consultants and Legal Professionals
- Business Development And Marketing Professionals
- Commercial Management Professionals
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting email@example.com. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Senior Regulatory Affairs Manager at Accestra Consulting
• Mr. Ng is based in China with almost a decade of regulatory affairs experience for Chinese market with a Master’s Degree from the University of Nottingham
• He has extensive knowledge of Chinese pharmaceutical regulatory requirements and has worked on numerous regulatory submissions with Chinese health authorities.
• Mr Ng has strong communication and practical experience dealing with the China NMPA (formerly CFDA) and CDE.
• A successful track record of supporting top 50 pharma companies as well as biotech and medtech with market entry into China.
China Pharmaceutical Regulatory Affairs Manager at Accestra Consulting
Ms. April Wang is devoted to helping overseas pharmaceutical companies understand Chinese regulatory requirements.
- She has in-depth understanding on Chinese Pharmaceutical Import & Export regulations and has accumulated extensive hands-on experience with drug registration projects during daily work, including Drug Registration, OTC registration, DMF filing.
- She has strong communication network with Chinese authorities including NMPA and CDE.
- Successful track record with supporting international pharma with market entry into China including well-known large enterprises and SMEs.
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