2024 - Global Regulatory Requirements for Drug Safety & Pharmacovigilance Certification Program

Training Overview
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 signaling and risk management.
This 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
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)
o ADR reporting
EU and ex-EU Requirements
Internet and Social Media
Post-Authorisation Studies
Biologics
o Periodic Safety Update Reports
Periodic Benefit-Risk Evaluation Report
PSUR Periodicity, ex-EU
PSUR Periodicity, EU
PSUR (PBRER) New Features
PSUR Sections: Detailed Requirements
o Signal management
MAH Responsibilities
Signal Detection
Signal Validation
EudraVigilance Monitoring
EudraVigilance Pilot Program
o UK Regulatory Requirements
UK QPPV
· Quiz Questions
Who Will Benefit
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