DUBLIN–(BUSINESS WIRE)–The “Understanding Pharmacovigilance Regulations in APAC Training Course” conference has been added to ResearchAndMarkets.com’s offering.
Pharmacovigilance regulations in Asia are dynamic and fast-changing
As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it’s vital to ensure compliance and safety by staying informed of the latest regulatory developments.
This two-day pharmacovigilance webinar has been designed to provide a comprehensive guide to compliance in this geographic region. It will provide an ideal opportunity to keep up-to-date with the latest Good Pharmacovigilance Practices (GVP) and post market PV operations in China, and post-market pharmacovigilance regulations in Singapore, Malaysia, the Philippines, and Australia.
Our panel of experts from this region will provide an overview of Good Pharmacovigilance Practices and discuss pharmacovigilance-related requirements. Gain key takeaways to better understand the new GVP regulations and pharmacovigilance compliance in these countries.
Don’t miss this opportunity to learn from industry leaders and enhance your knowledge of dynamic and fast-changing regulations in Asia, and the growing market in the Asia-Pacific region.
Benefits of Attending
- Gain a comprehensive overview of Pharmacovigilance regulations in China, Singapore, Malaysia, the Philippines, and Australia
- Stay updated with the latest Pharmacovigilance regulations in these countries
- Enhance your Pharmacovigilance-related knowledge and skills
- Understand the local requirements for RPPV (QPPV), PSMF, RMP, and other related regulations in each of these countries
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Who Should Attend:
- Professionals working in pharmacovigilance departments
- Drug safety specialists
- Adverse reaction monitoring professionals
- R&D professionals
- Regulatory affairs specialists
- Pharmaceutical physicians
Key Topics Covered
Day 1
Pharmacovigilance in China – GVP Overview
An Overview of China Pharmacovigilance
- Annual report of China’s 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
- Organizational 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
- 4 key tips
- 4 key pitfalls
- Authority inspection
- Q&A
Post-Market PV Operation
PV Operation – Individual Case Study Reports (ICSR)
- ICSR Overview
- Adverse Events Collection, Processing, and Submission to Regulatory Authorities
- National ADR Monitoring System Report Submission demonstration
Periodic Safety Update Report (PSUR)/PBRER
- Structures and contents
- Timelines
Day 2
Pharmacovigilance Regulations in Singapore, Malaysia, Philippines and Australia
Pharmacovigilance Regulations in Malaysia
- Introduction to Pharmacovigilance in Malaysia and Legal Basis
- Pharmacovigilance system
- Responsibilities of MAH, Responsible Person for PV (RPPV), Record Retention
- Managing ADR/AEFI reports
- Collection, Validation of reports, ADR reporting systems, Timeframes, and Submission requirements
- Periodic Benefit-Risk Evaluation (PBRERs)
- Overview, Format & content of PBRER, Submission requirements, Annexes
- Risk Management Plans (RMPs)
- Objective, Structure, Submission requirements, Risk Minimisation activities
- Pharmacovigilance System Master File (PSMF)
- Objective, Format & content of PSMF, Annexes
- Emerging Safety issues, Safety evaluation by NPRA, Safety communications
- Audits & Inspections
Pharmacovigilance Regulations in Singapore
- Introduction to Pharmacovigilance in Singapore and Legal Basis
- Responsibilities of the Company
- Adverse Event reporting
- Reporting requirements, Records, Special situation reporting
- Risk Management Plans
- Submission requirements, Documents, Risk Minimisation activities
- Periodic Benefit-Risk Evaluation (PBRERs)
- Actions taken by Regulatory Authorities
Pharmacovigilance Regulations in the Philippines
- Introduction to Pharmacovigilance in the Philippines and Legal Basis
- Pharmacovigilance system
- Reporting of Adverse Reactions
- Timeframes, Reporting requirements
- Significant safety Information
- Risk Management Plan (RMP)
- Submission requirements, Documents, Risk Minimisation activities
- Periodic Benefit-Risk Evaluation (PBRERs)
- Reporting requirements, Format & contents
- Actions taken by other national drug authorities
- PV inspections
Pharmacovigilance Regulations in Australia
- Introduction to Pharmacovigilance in Australia
- Pharmacovigilance system
- QPPVA and Australian PV contact person
- APSS (Australian Pharmacovigilance System Summary)
- DAEN Database
- Reporting of Adverse Reactions
- Timeframes, Reporting requirements.
- Significant safety issues
- Risk Management Plan (RMP) and Australia Specific Annex (ASA)
- Submission requirements, Documents, Risk Minimisation activities
- Periodic Safety Update Reports (PSUR)
- Reporting requirements, Format & contents
- Actions taken by other HA’s.
- PV inspections and Pharmacovigilance inspection program (PVIP)
For more information about this conference visit https://www.researchandmarkets.com/r/jzrt1q
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