Dublin, July 18, 2025 (GLOBE NEWSWIRE) -- The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance - Online Training (August 20, 2025)" has been added to ResearchAndMarkets.com's offering.
In the fast-paced world of pharmaceuticals, product safety is a critical issue with significant implications for company reputation, consumer trust, and investor confidence. Ensuring your pharmacovigilance operations align with the latest compliance expectations from the US, EU, and UK is essential to maintaining marketability. Are you prepared to navigate this complex landscape with robust risk assessment strategies?
Organizations lacking clarity on mandatory systems and processes for effective safety reporting may find themselves vulnerable to uncovering issues too late, potentially leading to severe consequences, including product recalls. It's crucial to possess a firm grasp of regulatory adherence and risk management practices that align with international standards and are capable of meeting regulatory requirements for signaling and risk management.
This meticulously developed training course offers a comprehensive introduction to product safety regulatory prerequisites, specifically designed for pharmaceutical and biologic companies operating within the US and EU. Participants will gain insights into the strategic decision-making and rationale required for incident reporting to regulatory bodies.
Course Highlights
- Comprehensive understanding of drug safety regulatory requirements.
- Detailed analysis of the US, EU, and UK regulatory frameworks, with specific focus on EU GVP modules and UK's additional requirements.
- In-depth look at the PV System Master File (PSMF) contents.
- Quality oversight prerequisites for drug safety.
- Regulatory standards for signal management.
- EU and UK QPPV responsibilities and compliance mandates.
- Guidance from an experienced and engaging instructor.
- Interactive multiple-choice quizzes to reinforce course understanding and retention.
With expert instruction and detailed curriculum, this course is essential for any company aiming to fortify their pharmacovigilance operations and ensure compliance with pivotal regulatory demands. Elevate your team's capabilities and safeguard your product's market longevity today.
Who Should Attend:
Almost everyone involved in drug development and marketing needs to know the basics of worldwide regulations regarding drug safety.
Staff who will benefit include:
- Drug safety and pharmacovigilance
- Regulatory affairs
- Clinical development
- Executives (including C-Level) with any legal responsibility for drug safety
Course Agenda:
Global Regulatory Requirements
- Legalities
- Penalties for Non-Compliance
- Matrix of Safety Regulations
- FDA Regulations
- International Conference on Harmonisation (ICH)
- CIOMS
- Canadian Regulations
- Key EU Components
- EudraVigilance
- CTIS
- Qualified Person for Pharmacovigilance (QPPV) requirements
- Development Safety Update Report
- European Signaling Regulations
EU Pharmacovigilance Legislation
- Summary of Requirements
- Penalties and fees
- GVP modules
- Quality systems
- Audit and inspection
- PV System Master File (PSMF)
ADR reporting
- EU and ex-EU Requirements
- Internet and Social Media
- Post-Authorisation Studies
- Biologics
Periodic Safety Update Reports
- Periodic Benefit-Risk Evaluation Report
- PSUR Periodicity
- PSUR (PBRER) New Features
- PSUR Sections: Detailed Requirements
Signal management
- MAH Responsibilities
- Signal Detection
- Signal Validation
- EudraVigilance Monitoring
- EudraVigilance Pilot Program
UK Regulatory Requirements
- UK QPPV
Quiz Questions
For more information about this training visit https://www.researchandmarkets.com/r/tizl4u
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