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What you'll learn

Training #1 Advanced Pharmacovigilance Auditing and Inspections - 6 hrs Duration

Training #2 Global Regulatory Requirements for Drug Safety & Pharmacovigilance - 3 hrs Duration

Course content

Training #1 Advanced Pharmacovigilance Auditing and Inspections

Agenda Day 1

•      Introductions


ICH- Guidance US/EU/Japan

ICH Q10 – Pharmaceutical Quality System

•      Life time of a Product

•      Resources to monitor the QS

ICH Q9 – Quality Risk Management

•      Risk Management Methods and Tools

ICH E2- Clinical Safety Data Management

21 CFR Part 314:80/81

EU GVP Module IV (R1) – PV audits (12AUG2015)

•      Risk Based approach

•      Strategic Level (2-5 years)

•      Tactical level

•      Operational level

Pharmacovigilance System Master File

•      GVP Module II – PSMF (31MAR2017)

•      Main body covers the PV QMS including QA

•      Annex G – Quality System:

Audit schedules

List of audits conducted and completed

Significant CAPAs

•      Background & Design of QA Programme

Strategic Level– Plan to cover:

•      All pharmacovigilance activities

•      The Quality Management System (QMS) for pharmacovigilance activities

•      Interactions with other company departments, as appropriate (GMP, Regulatory Affairs)

•      Pharmacovigilance activities conducted by affiliated organisations

•      Pharmacovigilance activities conducted by third parties

Strategic Level

·     Service Level Agreements – outlines

·     SDEA

·     Key Performance Indicators (KPI)

Tactical Level Planning

Tactical Aspects

Operational Level

Pre-Audit Questionnaires


Case study/Exercise with Q&A

Implementation of a PVQA Audit Programme

·     Exercise – Design a QA Audit Programme for Company A

·     Some questions to consider

End of Day 1

Agenda Day 2

Q&A session from Day 1

PV Inspections

·     EU GVP Module III – PV Inspections (16SEP2014)

·     EMA Remote PV Inspections – During crisis situations(SEP2020)

·     MHRA guidance on Remote Inspections

·     Routine Inspections

·     Pre-Authorisation Inspections

·     ‘For Cause’ Inspection

·     Preparing for a PV Inspection

·     Tools

·     Inspection Checklist (Plan) should cover

·     Document Request form

·     Metrics from MHRA 2020 Symposium, London

·     SMART Responses when drafting CAPAs

Audit & Inspection findings

·     Questions to consider

·     Case Study 1

·     Case Study 2

·     Case Study 3

Q&A session

Certificate of Completion for 2 Days Virtual Training Online on Advanced Pharmacovigilance Auditing & Inspections

Training #2 Global Regulatory Requirements for Drug Safety & Pharmacovigilance - 3 hrs Duration

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
  • Canadian Regulations
  • Key EU Components
  • EU Member States
  • What is Europe? EU, EEA, EFTA
  • Eudravigilance – Pre-Marketing Requirements   
  • Eudravigilance – Post-Marketing Requirements
  • 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


·      Quiz Questions

Who Will Benefit

This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities. Almost everyone involved in drug development and marketing needs to know the basics of worldwide regulations regarding drug safety

The following personnel will benefit from the course:

  • PV Quality Assurance Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance Auditors
  • Relevant Pharmacovigilance Staff
  • PV Service Provider Relationship Managers
  • MAH Affiliates responsible for Pharmacovigilance
  • Drug safety and pharmacovigilance
  • Regulatory affairs
  • Clinical development
  • Executives (including C-Level) with any legal responsibility for drug safety.

How to Earn Your Pharmacovigilance Certification?

Becoming a attendee is easy.

  • Enrol: Register for the complete 9 hrs course program. You will receive an email with instructions on accessing the courses.
  • Learn: Attend each of the courses and successfully pass the self-assessment with a score of 80% or higher.
  • Earn: Once you have fulfilled all the program requirements, you will receive a certificate recognizing your achievement.