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About us
Practical Pharmacovigilance Auditing
Course Information
This well established course will explore key phases of pharmacovigilance auditing. It will address the impact of the EU pharmacovigilance legislation on auditing and provide guidance on auditing pharmacovigilance systems at both the global and local organisational level.
Is this course for you?
This course is designed for pharmacovigilance auditors, auditors new to pharmacovigilance and pharmacovigilance professionals to provide them with insight into developing and/or optimising a pharmacovigilance audit programme. In order to gain maximum benefit from the course, an understanding of pharmacovigilance is advantageous.
This course will assist delegates with:
- A practical approach for the development and conduct of pharmacovigilance audits
- An enhanced understanding of key pharmacovigilance audit principles, preparation, design and conduct
- Increased expertise, efficiency and confidence.
Tutors
Tutors will be comprised of (click the photos for biographies):
Mark Parker
Lauren Ewen
Mijal Chavda
Mijal is responsible for the oversight, management, and execution of Global GxP Inspections and GVP Audits at Kyowa Kirin. Mijal has over 20 years’ experience in the Pharma/Drug Development industry and has successfully led numerous Health Authority Inspections. Her experience has been gained from working in various positions throughout her career in both large/small Pharma companies and multinational CROs/service providers. She strives to be the best at what she does and has achieved a high level of excellence throughout her career.
Bhagti Khera
Bhagti has over 15 years' experience within the Pharmaceutical industry conducting global audits and supporting regulatory inspections.
She started her career within GCP and moved into Quality Assurance where she gained experience in Pharmacovigilance. Bhagti has experience working within large and small pharmaceutical companies where her roles have previously included responsibility as the Head of PVQA.
Bhagti currently works at Norgine Limited responsible for the global pharmacovigilance audit programme and management of PV inspections.
Jonathan Rowell
Associate Director Regulatory Compliance, Janssen, Pharmaceutical Companies of Johnson & Johnson
View pop upJonathan Rowell
Jonathan started his pharmaceutical career in 2005. He joined the MHRA in 2009 and was responsible for Pharmacovigilance Inspections at Global Headquarters, local subsidiaries, and virtual UK operations. He acted as UK delegate to the EU Inspectors Working Group.
Jonathan moved to Johnson and Johnson in 2015 to work in compliance oversight and inspection management. In his current role, Jonathan is the Head of the pharmacovigilance audit programme.
Jonathan has a BSc in Genetics from Leicester University and a post-graduate diploma in Pharmacovigilance from the University of Hertfordshire.
Programme
Please note timings may be subject to alteration.
Day 1
09:15
Registration
09:30
Welcome and Introductions and Introduction to the Workshops
The objectives of the workshops are defined and process and outputs described.
10:00
Pharmacovigilance Audit - Requirements and Expectations
EU PV legislation (relevant Regulations and Directives) and key highlights from Module I, II, IV relating to PV auditing.
10:45
Break
11:00
Audit Planning and Scheduling
Understanding and defining the PV Audit universe, applying risk-based audit strategy, using risk assessment and risk criteria, identifying an audit schedule and resourcing audits.
11:45
Audit Types, Processes and Preparation
Types of PV audits, QA audit process requirements and tools necessary to execute audit programmes. Detailed information on how to prepare for audits (by audit type), common features in audit preparation and perhaps a table to show differences on preparation by audit types and planning individual audits (e.g. preparation, audit planning, audit conduct, audit reporting, CAPA management).
12:30
Lunch
13:30
Auditing Affiliates/Local Operating Companies
Auditing the processes and systems in place at local affiliate offices including post-marketing surveillance, clinical trials, medical information, regulatory, sales/marketing etc.
14:30
Workshop 1 - Audit Schedule
15:30
Workshop 1 - Feedback
16:00
Close of Day
Day 2
09:00
Case Processing (from all sources)
Auditing the processes and systems designed for processing clinical trial and post marketing cases.
10:00
Auditing the QPPV and the PSMF
Auditing the roles and responsibilities of the Qualified Person responsible for Pharmacovigilance and the Pharmacovigilance System Master File.
11:00
Break
11:15
Workshop 2 - Planning a System Audit
12:00
Workshop 2 - Feedback
12:30
Lunch
13:30
Auditing Third Parties
Contracts, safety data exchange agreements, outsourcing and oversight by the Marketing Authorisation Holder.
14:30
Risk Management Systems Part 1, including:
- Signal management - Labelling - Risk management plans and risk minimisation.
15:45
Break
16:00
Workshop 3 - Speed Auditing
16:45
Close of Day
Day 3
09:00
Risk Management Systems Part 2, including:
- PASS - PSUR (PBER) and DSUR - Safety communications (DHPC).
10:15
Break
10:30
Audit Report Writing and CAPA Management
11:15
Hot Topics
- PV QMS - Market Research/PSP - Archiving/Business continuity.
12:00
Lunch
13:00
Regulatory Inspection and Audit of Quality Assurance
Are your audit programme and quality assurance function inspection ready? Hints and tips on being the interviewee.
14:00
Final Wrap Up
An opportunity for open discussion on topics raised during the course or relevant to it.
15:00
Close of Course
Extra Information
Course Material
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
The advantages of this include:
- Ability for delegates to keep material on a mobile device
- Ability to review material at any time pre and post course
- Environmental benefits – less paper being used per course Access to an online course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
Course Material
Course material will be available in PDF format for delegates attending this course. The advantages of this include:
- Ability for delegates to keep material on a mobile device
- Ability to review material at any time pre and post course
- Environmental benefits – less paper being used per course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
CPD Points
19 Points
Development Level
Develop
Recommended Products
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet
Pharmacovigilance Auditing eBooklet
Webcast - Where Does Audit End?