This course is an intensive 1,5 days pharmacovigilance training course with focus on GVP guidelines. The course will elaborate from current GVP guidelines and system changes from the EMA implemented recently.
Learning Objectives:
The course will elaborate on how these changes will affect the day-to-day pharmacovigilance operations within the pharmaceutical companies with practical examples, which will be based on real life situations regarding electronic transmissions, signal management and organizational aspects affected by new draft GVP modules and the EMA's system changes.
Who will Benefit:
This one and half day seminar will provide invaluable assistance to all personnel in the pharmacovigilance field, who have a stake in understanding Good Pharmacovigilance Practices guidelines and how to apply them into their day to day.
This seminar will be particularly useful for those involved in case handling, periodic reporting, signal management and pharmacovigilance audits and inspections.
Those employees working in the following roles will significantly benefit by attending:
- QPPVs
- Local contact persons for pharmacovigilance
- Safety officers
- Pharmacovigilance quality assurance personnel
- 8:30 AM - 8:59 AM: Registration, Meet & Greet.
- 9:00 – 10:30 AM: Introduction and presentation of participants
- Overview of GVP
- Current and draft modules, timelines for implementation
- 10:30 AM - 11:00 AM: Coffee break
- 11:00 AM: – 12:30 PM: Quality Systems in PV:
This session will explain the main concepts of the Module I of the GVP guidelines, with focus on the Pharmacovigilance quality management system, the Pharmacovigilance System Master File and the modules III and IV on inspections and audits:
- Quality Systems in PV
- GVP Module I
- PSMF
- GVP Module II
- Inspection and audits
- GVP Modules III and IV
- 12:30 PM - 1:30 PM: Lunch break
- 1:30 PM – 3:00 PM:
During this session, the new module VI of the GVP will be explained. This is one of the most important modules for day to day pharmacovigilance:
- Adverse reaction reporting, GVP mod VI
- Definitions
- ICSR management
- Business processes
- Accessing Eudravigilance
- Principles of accessing EudraVigilance data
- E2B from R2 to R3, impact in pharmacovigilance
- E2B R3 fields
- 3:00 PM: – 3:30 PM: Coffee break
- 3:30 PM: – 4:30 PM: Periodic reporting: During this session, the GVP Module VII will be addressed:
- GVP Mod VII
- Introduction
- Structures and processes
- Format and contents
- Quality Systems
- Operation of the EU network
- 4:30 PM: End day 1
- 9:00 AM: – 10:30 AM:
Signal management in Pharmacovigilance: This session will focus on the recently updated module IX of the GVP guidelines on Signal Management. The process of signal management and the role of the EVDAS will be also reviewed:
- GVP Mod IX
- GVP Mod IX, what’s new
- Signal management process
- Signal management at the EMA
- 10:30 AM: - 11:00 AM: Coffee break
- 11:00 AM: – 1:00 PM:
This summary session will conclude on the main activities to be taken into account by different organizations in order to adapt to the latest changes in the GVP modules:
- Prepare for change
- New EMA training
- Organizational considerations within the MAHs
- A global perspective and conclusions
- 1:00 PM: – 1:30 PM: End of training
Jose Alberto Ortiz
CEO, pharmacovigilance consultant
Jose Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for IT systems and Electronic transmissions.
Besides his day-to-day Pharmacovigilance work as a consultant, he is an active trainer of the EVWeb and XEVMPD training courses since 2003, and collaborates together with the training team, the EMA and the DIA in the development of these training courses. He provides also local QPPV services for Pharmaceutical Companies.
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