Dublin, July 10, 2024 (GLOBE NEWSWIRE) -- The "Advanced Pharmacovigilance Training Course" conference has been added to ResearchAndMarkets.com's offering.
Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex range of safety and risk assessment activities to perform. This three-day course is designed for those with at least two years' knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company.
Key topics to be addressed:
- Audits and expectations - risk-based inspections
- Compliance and drug safety
- Overview of the PSMF in the EU
- Product safety reviews - purpose and function (incorporating the latest EU signal analysis requirements)
- Safety reporting in licensing agreements
- Developing company core safety information (CCSI) - CIOMS III
- PSURs - timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
- Implications for safety reporting in global clinical trials
- Risk-benefit determinations
- Risk management plans (RMPs)
Benefits of attending:
- Expand your global safety knowledge
- Enhance your team's capabilities and compliance in both the regulations and your company's expectations
- Help ensure you build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection
- Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspections
Certifications:
- CPD: 18 hours for your records
- Certificate of completion
Who Should Attend?
This course would be of maximum benefit to those safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing. The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.
For more information about this conference visit https://www.researchandmarkets.com/r/ohstoc
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
