PharmStart: Pharmacovigilance: Introduction and Core Concepts
Dates
Past dates: 2–5 May 2024
Format
Online
Course Objectives
Participants will gain an overview of pharmacovigilance, including core concepts, legislation, relevant organizations, and the Good Pharmacovigilance Practices guideline modules. The course is for those starting a career in pharmacovigilance and pharmaceutical industry professionals seeking to master the fundamentals of the subject.
Who Can Attend
- Those starting a career in pharmacovigilance
- Pharmaceutical industry professionals seeking to learn the fundamentals of pharmacovigilance
- Students
Course Content
- Pharmacovigilance: Introduction, core concepts, definitions, legislation, and relevant organizations
- Responsibilities of the Qualified Person for Pharmacovigilance (QPPV)
- Good Pharmacovigilance Practices (GVP) Guideline Module I: Management and Reporting of Adverse Drug Reactions
- MedDRA training and case examples
- Monitoring scientific and medical literature
- GVP Module II: Additional Monitoring
- GVP Module III: Periodic Benefit-Risk Evaluation Report
Duration and Capacity
Duration: 12 hours
Capacity: 40 participants
Course Coordinator
- Prof. Dr. Belma Gümüşel
- Prof. Dr. Bülent Gümüşel
- Pharmacist Dicle Balbay
- Pharmacist Meryem Yaman
Instructors
- Prof. Dr. Belma Gümüşel
- Prof. Dr. Bülent Gümüşel
- Pharmacist Dicle Balbay
- Pharmacist Meryem Yaman
- Pharmacist Ece Naz Akın
- Pharmacist Reyhan Cantekin
- Pharmacist Gülnara Alimova
- Pharmacist Ceren Kaya
- Pharmacist Ayşenur Köse
Fee
Recorded course
Request pricing
Terms
Course fees include VAT. / Participants will receive a “Certificate of Attendance” at the end of the course.
Lesson Videos
Available for 1 month, only to the member who purchased this program.
- Lesson 1 Pharmacovigilance: Introduction and Legislation
- Lesson 2 Core Concepts in Pharmacovigilance and Responsibilities of the QPPV
- Lesson 3 GVP Module I – Pharmacist Reyhan Cantekin
- Lesson 4 MedDRA Training – Pharmacist Reyhan Cantekin
- Lesson 5 Case Examples and Ministry Correspondence – Pharmacist Reyhan Cantekin
- Lesson 6 Monitoring Scientific and Medical Literature – Specialist Pharmacist Ceren Kaya
- Lesson 7 GVP Module II – Additional Monitoring – Pharmacist Ayşenur Köse
- Lesson 8 GVP Module III – Periodic Benefit-Risk Evaluation Report (PBRER) – Pharmacist Meryem Yaman and Pharmacist Gülnara Alimova