Presented by
Management Forum
Understanding Pharmacovigilance Regulations in China Training Course
A Practical Guide to China GVP Compliance, NMPA Requirements and Pharmacovigilance Audits.
27 April 2027
+ 11 October 2027 »
from £350
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
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.
This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.
Benefits of attending
By attending this webinar, you will:
- Gain a comprehensive understanding of China's pharmacovigilance regulatory framework and current GVP requirements
- Stay up to date with the latest developments in China Pharmacovigilance and NMPA expectations
- Understand how to establish and maintain a compliant pharmacovigilance system in China
- Learn the local regulatory requirements for:
- Responsible Person for Pharmacovigilance (RPPV)
- Pharmacovigilance System Master File (PSMF)
- Risk Management Plan (RMP)
- Aggregate Safety Reports (PSUR/PBRER)
- Individual Case Safety Reports (ICSRs)
- Understand how GVP inspections are conducted by Chinese regulatory authorities
- Learn practical approaches to planning, conducting, and preparing for GVP audits of local partners and service providers
- Identify common compliance challenges and best practices for successful inspections
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
This course will cover:
An overview of pharmacovigilance in China
- Annual report of China national ADR monitoring
- China PV concept
- PV development in China
- Competent authorities
- National systems introduction
China GVP 2021 introduction and requirements
- Quality management: PV system, quality objective, QA system, QC indicators
- Organisational structure, personnel, resources: RPPV (QPPV), PV department
- Monitor and report: data collection, ICSR case processing, report submission, literature search
- Risk identification and evaluation: incl. PSUR/PBRER, post marketing safety study
- Risk control: risk control measures, risk communication, PV plan (RMP)
- Documentation, record and data management: incl. PSMF
- PV annual report
- Brief introduction of clinical PV requirements
Best practices for compliance with China’s GVP requirements
- Four key tips
- Four key pitfalls
- Authority inspection
- Q&A session
PV operation - Individual Case Safety Reports (ICSR)
- ICSR Overview
- Adverse Events Collection, Processing, Submission to Regulatory Authorities
- National ADR Monitoring System Report Submission demonstration
Aggregate reports
- Structures and contents
- Timelines
Signals and risk management
- Signal detection and management
- Risk management activities
China GVP audit
- General audit scope
- Audit workflow
- Inspection readiness
Marylène Zhan
PV Solutions Limited (HK)
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
Please contact us for pricing if you are interested in booking 5 or more delegates
27 April 2027
Live online
09:30-12:30 UK (London) (UTC+01)
10:30-13:30 Paris (UTC+02)
04:30-07:30 New York (UTC-04)
Course code 17631
- GBP 350 400
- EUR 490 560
- USD 562 640
Until 23 Mar
- 3 hours live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
11 October 2027
Live online
09:30-12:30 UK (London) (UTC+01)
10:30-13:30 Paris (UTC+02)
04:30-07:30 New York (UTC-04)
Course code 17632
- GBP 350 400
- EUR 490 560
- USD 562 640
Until 06 Sep
- 3 hours live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
