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. 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.
Tutors will be comprised from the list below:
Director, CM Quality Ltd (Course Principal)
Senior Manager, Allergan Ltd
Otsuka Europe Development and Commercialisation
Global PV QA Consultancy Limited
Johnson & Johnson
"PV auditing class with Pam Bones, Kim Palmer, and Lauren Ewen was excellent!!! I learned a great deal over the 3 days course and highly recommend the course."
"Very comprehensive training which allows me to understand the whole process of PV auditing with the focus on EU regulations (but not only). Very good and valuable training materials. One of my colleagues suggested me to take this training as "one of the best" for new auditor and she was right. 100% satisfied, worth every penny."
|9.15||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.
||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 (eg preparation, audit planning, audit conduct, audit reporting, CAPA management).
|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|
|9.00||Auditing Case Management Activities
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.
|11.15||Workshop 2 - Planning a System Audit|
|12.15||Workshop 2 - Feedback|
|13.30||Auditing External Business Partners
Contracts, safety data exchange agreements, outsourcing and oversight by the Marketing Authorisation Holder.
|14.30||Risk Management Systems Part 1, including:
- Signal management
- Risk management plans and risk minimisation
|16.00||Workshop 3 - Speed Auditing|
|16.45||Close of day|
|9.00||Risk Management Systems Part 2, including:
- PSUR (PBER) and DSUR
|10.30||Audit Report Writing and CAPA Management|
- PV QMS
- Market Research/PSP
- Archiving/Business continuity.
|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|
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.
You will need a stable internet connection, a microphone and a webcam.
You will also receive a PDF copy of our booklet - "Pharmacovigilance Auditing"