Regulatory Requirements for Drug Safety & Pharmacovigilance - Online Training Event, August 20, 2025: Stay Compliant Across US, EU, and UK - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance (August 20, 2025)" online training has been added to ResearchAndMarkets.com's offering.

Product safety makes headlines every day - and the impact on a company's image, consumer confidence, and Wall Street's opinion is profound.

Are you confident your current pharmacovigilance operations will meet the latest US, EU and UK expectations for compliance and keep your products on the market? Do you understand the processes needed to perform adequate risk assessment?

Not knowing which systems and processes you must have in place for your own safety reporting could mean you miss an important issue with significant consequences for your product. You must be sure you have the understanding you need to avoid product recall, are able to work to international standards and have implemented regulatory requirements for signalling and risk management.

The Global Regulatory Requirements for Drug Safety & Pharmacovigilance training course is designed to give pharmaceutical and biologic companies operating in the US and EU an introduction to product safety regulatory requirements.

The course will illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.

What You'll Learn

• 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

Quiz Questions

For more information about this training visit https://www.researchandmarkets.com/r/az1doz

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