Course overview
China's pharmacovigilance (PV) regulatory landscape continues to evolve rapidly, making regulatory compliance increasingly important for pharmaceutical companies operating or planning to enter the Chinese market.
This comprehensive half-day webinar provides an up-to-date overview of China Good Pharmacovigilance Practice (GVP) requirements, post-marketing pharmacovigilance operations, and regulatory expectations from the National Medical Products Administration (NMPA). Participants will gain practical insights into implementing compliant pharmacovigilance systems while understanding how Chinese regulatory requirements align with global pharmacovigilance standards.
Led by experienced pharmacovigilance experts with extensive hands-on experience in China, the programme covers the complete lifecycle of local PV compliance, including GVP requirements, post-marketing safety activities, regulatory inspections, and GCP/GVP audits.
Whether you are responsible for global pharmacovigilance, local affiliate compliance, or vendor oversight, this webinar will help you better understand China's regulatory expectations, avoid common compliance pitfalls, and strengthen your pharmacovigilance quality system.
Join us to stay ahead of the latest developments in China's pharmacovigilance regulations and confidently manage compliance within one of the world's largest pharmaceutical markets.
CPD Hours: 3
Course Content
- Day 1
- An overview of pharmacovigilance in China
- China GVP 2021 introduction and requirements
- Best practices for compliance with China’s GVP requirements
- PV operation - Individual Case Safety Reports (ICSR)
- Aggregate reports
- Signals and risk management
- China GVP audit
Speakers
Marylène Zhan
Founder of PV Solutions Limited
Ms. Marylène Zhan has over 10 years of experience in pharmacovigilance (PV) and regulatory affairs (RA), with extensive expertise in supporting international pharmaceutical companies entering and operating in the Chinese market. She holds a Master’s degree from Zhongnan University of Economics and Law.
As a bilingual and bicultural regulatory consultant, Marylène specialises in China regulatory compliance and pharmacovigilance services. She possesses in-depth knowledge of China’s pharmaceutical regulatory framework and extensive experience navigating complex market access and compliance requirements.
Throughout her career, Marylène has successfully supported multinational pharmaceutical and biotechnology companies in achieving regulatory compliance in China. Her areas of expertise include GCP and GVP audits, Chinese GVP implementation and compliance, pharmacovigilance system establishment and optimisation, SOP development and quality management systems, regulatory intelligence, inspection readiness, and strategic regulatory consulting. She is committed to helping global organisations build compliant, efficient, and sustainable pharmacovigilance systems that meet China’s evolving regulatory expectations.
Sherley Wang
Dr. Sherley Wang has over 16 years of experience in the pharmaceutical industry, including 11 years in pharmacovigilance and 5 years in clinical quality assurance. She has worked with leading multinational pharmaceutical companies and completed over 200 audits of hospital research centers and 150 audits of CROs and pharma companies. She is also an authorised RPPV/QPPV for several domestic pharma companies.
She authored the China Pharmacovigilance Industry Research Report 2024 and contributed to the translation of key pharmacovigilance books in collaboration with the CDE of NMPA. Sherley is a panel expert at the China Food and Drug Industries Quality and Safety Promotion Association (FDSA). She also teaches pharmacovigilance to graduate students at Tongji Medical College, Huazhong University of Science and Technology. She published a research report titled “2024 China Pharmacovigilance Industry Research Report”, which received widespread attention in the industry.
As a member of the China Institute of Internal Audit (CIIA), Sherley is well-versed in GCP, GLP, GVP, and supplier audits, as well as regulatory inspections. She has deep knowledge of both domestic and international regulatory environments. Her experience enables her to support the setup and oversight of compliant PV systems for pharma companies.
Who Should Attend
Who should attend
This webinar is designed for professionals involved in pharmacovigilance, drug safety, regulatory compliance, quality management, and GVP inspections and audits in China.
It is particularly relevant for:
- Pharmacovigilance professionals
- Drug Safety Specialists
- Pharmacovigilance Managers
- Medical Safety Scientists
- Adverse Event Case Processing Teams
- Regulatory Affairs Professionals
- Quality Assurance and GxP Auditors
- Clinical Safety Professionals
- Pharmaceutical Physicians
- Global PV and Local Affiliate Managers
