Two Day Advanced Pharmacovigilance Auditing and Inspections Course (September 15-16, 2022)
12 Sep 2022
DUBLIN, Sept. 12, 2022 /PRNewswire/ -- Final days to register for the "Advanced Pharmacovigilance Auditing and Inspections Course" that has been added to
ResearchAndMarkets.com's offering.
This seminar will also 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.
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 Should Attend:
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
Key Topics Covered:
Agenda Day 1
Introductions (12:30 - 12:45 EDT)
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 (12:45 - 02:00 PM EDT)
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
Service Level Agreements - outlines
SDEA
Key Performance Indicators (KPI)
Tactical Level Planning
Pre-Audit Questionnaires
BREAK (02:00 PM - 02:15 PM EDT)
Case study/Exercise with Q&A (02:15 PM - 03:30 PM EDT)
Implementation of a PVQA Audit Programme
Exercise - Design a QA Audit Programme for Company A
Some questions to consider
End of Day 1 (03:30 PM EDT)
Agenda Day 2
Q&A session from Day 1 (12:30 PM - 01:00 PM EDT)
PV Inspections (01:00 PM - 02:30 PM EDT)
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 (02:30-02:45 PM EDT)
Questions to consider
Case Study 1
Case Study 2
Case Study 3
Q&A session (02:45 PM - 03:30 PM EDT)
Certificate of Completion for 2 Days Virtual Training Online on Advanced Pharmacovigilance Auditing & Inspections
For more information about this training visit https://www.researchandmarkets.com/r/gbr0yg
Media Contact:
Research and Markets
Laura Wood, Senior Manager
[email protected]
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