Dublin, May 26, 2025 (GLOBE NEWSWIRE) -- The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance Certification Program (ONLINE EVENT: May 29, 2025)" has been added to ResearchAndMarkets.com's offering.
In today's fast-paced landscape, ensuring comprehensive product safety is paramount for safeguarding a company's reputation and maintaining consumer trust. Companies need to be vigilant about their pharmacovigilance operations to align with evolving US, EU, and UK compliance standards and avoid disruptions in their market presence. Critical to this process is having a thorough understanding of the necessary systems for effective safety reporting and risk assessment.
Failure to establish essential processes for safety reporting can result in overlooked issues, leading to significant repercussions, including product recall and non-compliance penalties. Active engagement with international safety standards and regulatory requirements for signaling and risk management remains crucial for sustaining market approval and consumer confidence.
Our specialized training course is tailored to guide pharmaceutical and biologic companies in the US and EU through the intricate landscape of product safety regulatory requirements. Participants will gain valuable insights into the strategic decision-making responsible for reporting incidents to regulatory authorities efficiently and effectively.
Key Highlights of the Training:
- An understanding of regulatory requirements for drug safety
- Overview of US, EU and UK regulatory framework, including details of EU GVP modules and additional requirements for the UK
- Contents of the PV System Master File (PSMF)
- Requirements for quality oversight of drug safety
- Regulations for signal management
- EU and UK QPPV requirements and responsibilities
- An engaging and experienced instructor
- Multiple choice quizzes to test your understanding of the course
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 - US
- Legalities - EU
- Penalties for Non-Compliance
- Matrix of Safety Regulations
- FDA Regulations
- FDA Regulation for IND safety reporting
- IND Annual Report
- Literature Reporting
- International Conference on Harmonisation (ICH)
- ICH Topic Codes and Reports
- CIOMS
- Canadian Regulations
- Key EU Components
- EU Member States
- What is Europe? EU, EEA, EFTA
- EudraVigilance - Pre-Marketing Requirements
- EudraVigilance - Post-Marketing Requirements
- EUDRACT
- EU Clinical Trial Directive
- EU Clinical Trials Regulation
- 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, ex-EU
- PSUR Periodicity, EU
- 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
For more information about this training visit https://www.researchandmarkets.com/r/4dqy5l
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