Advanced Pharmacovigilance Auditing and Inspections

RAPS - This course has been pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.

Training Overview

Pharmacovigilance Auditing and Inspections Virtual Live Training Course

This seminar will also have a focus on the risk base approaches in response to COVID - 19 including recent legislation governing the conduct of these activities. PV Audit Strategy Planning course will provide an overview of the European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness.

It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities.

Agenda

Agenda Day 1

•      Introductions

Regulations

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

BREAK

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 Half Days Virtual Training Online on Advanced Pharmacovigilance Auditing & Inspections

Learning Objectives

Upon completing of this course, participants should be able to:

• Understand the legal requirements and health authority expectations for a risk-based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
• Develop a high-level PV audit strategy
• Identify the PV activities and processes subject to PV audit
• Develop risk assessment criteria
• Identify the PV audit universe – entities subject to PV audit
• Categorize the entities subject to PV audit
• Perform risk assessments
• Prioritize entities for audit according to relative risk
• Prepare a 3–5-year PV audit plan
• Identify procedures/tools to monitor PV quality of third parties

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.

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