of 2012, the “gold” standard of pharmacovigilance (PV) and adverse event (AE)
reporting on a global level is based on the European Medicines Agency (EMA) PV
Modules, which require that Quality Assurance (QA) be part of the quality
management system (QMS), and that PV audits be performed at various levels and
at varying sites. Although most Good Clinical Practice (GCP) experts are
familiar with pre-marketing drug safety, there is a difference to
post-marketing PV and the associated activities.
This is an introductory
course for those unfamiliar with the EMA PV Modules or global reporting
requirements. The basics of EMA (and FDA) expectations on the receipt,
processing, reporting, and management of AEs for marketed products (drug and
device), and how to prepare for auditing these systems will be presented.
Learners will be shown the basic concepts of reportable events, timelines of
reporting, what the global PV department is responsible for, and the audit
process to be applied for both systematic internal audits as well as at
affiliated offices and PV vendors. The course will include presentations,
discussions, and problem-solving techniques using case studies applicable to
both drug and device marketed products. Exercises are designed to help you
understand what the PV process actually is and how to apply an auditing
- Recognize post-marketing PV expectations and
compliance on a global level
- Review the EMA PV Modules at the
- Determine PV reporting
responsibilities applicable to global PV submissions
- Apply basic auditing concepts to
assess PV compliance
- Heads of Pharmacovigilance Quality Assurance
- Auditors transitioning into pharmacovigilance
- Drug Safety Staff
- Quality Assurance Staff responsible
for pharmacovigilance self-inspections
- Medical Information Staff
- Safety Physicians
The course will be led by one of the following
Click here for complete trainer
Day One: 8:30 a.m. – 5:00 p.m.
- EMA PV Modules and FDA Safety Reporting Basics
- Systems Used in PV Data Gathering and Individual Safety Case
- Understanding Periodic Safety Update Reports (PSURs)
- Eudravigilance & Signal Detection
- Hands-on Exercise: Reviewing “AE Source Documents” & Resulting ICSRs
- Reviewing Periodic Safety Update Reports
Two: 8:30 a.m. – 5:00 p.m.
- PV Audit Plans, Scope, and Agendas
- PV Audit Questionnaires and Checklists
- Current EMA/FDA PV inspection findings
- Hands-on Exercise: Drafting the audit agendas and checklists for: System
Audit, Affiliate Audit, Vendor Audit
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
Click here for our seminar
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 15 hours (1.5 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-18-003-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1