Dublin, June 4, 2024 (Business Wire) — The “PSMF Online Training – A Technical Training Program on Creating and Maintaining Pharmacovigilance System Master File (PSMF)” has been added to ResearchAndMarkets.com’s offerings. This training program is essential for companies maintaining a pharmacovigilance system, a global legal requirement.
Understanding PSMF
The Pharmacovigilance System Master File (PSMF) offers a comprehensive overview of a company’s pharmacovigilance system, ensuring compliance and safety information for medicinal products. The PSMF must reflect global safety data, not just local or regional activities.
Common Challenges
Many companies face challenges in maintaining their PSMF, including deficiencies in content and compliance. This training program addresses these issues and helps professionals make their PSMF inspection-ready for regulatory authorities.
More Articles:
- Unlock the World of AI with a Comprehensive Online Learning Bundle
- Empowering Online Students: Enhancing Well-being and Academic Success
Learning Objectives
Participants will learn to:
- Discuss the content of the Pharmacovigilance System Master File.
- Create and maintain a PSMF for regulatory inspections.
- Overcome challenges in preparing and maintaining a PSMF.
Who Should Attend
This training is ideal for professionals involved in:
- Pharmacovigilance (including QPPV)
- Clinical Research
- Risk Management
- Drug Safety Assessment
- Safety Data Analysis
- Pharmacoepidemiology
- Information Technology
- Regulatory Affairs
- Pharmacovigilance consultancy
- Quality and Compliance
Key Topics Covered
The training covers various critical topics, including:
- Introduction and history of PSMF
- PSMF regulations by country
- Core sections and annexes of the PSMF
- Creating and maintaining each section of the PSMF
- Compliance with EU regulations
- Submission and maintenance processes
- Managing deviations and implementing corrective actions
Expert Speaker
Sunil Verma, Director of the Academy of Clinical Intelligence, leads the training. With over 10 years in the clinical research industry, Sunil has extensive experience in pharmacovigilance, clinical research, and medical writing. His expertise ensures high-quality training in creating and maintaining PSMF.
Conclusion
Strengthening your pharmacovigilance knowledge with this PSMF online training course will enhance your ability to manage drug safety and regulatory compliance. For more information and to register, visit ResearchAndMarkets.com.