Maii Said Kataif
Memphis Co. for Pharmaceuticals & Ch. Industries, Egypt
Title: Introduction to Pharmacovigilance
Biography
Biography: Maii Said Kataif
Abstract
1- What is Pharmacovigilance 1.1 Smooth orientation to the idea 1.2 WHO Definition of Pharmacovigilance 2- Why do we need Pharmacovigilance 2.1 Learning from History 2.2 Drug safety throughout product life cycle 3- Scope of Pharmacovigilance 4- Important Terminologies in Pharmacovigilance 5- Marketing the idea of Pharmacovigilance 6- Global vision of Pharmacovigilance 6.1 WHO programme for International Drug Monitoring 6.2 Harmonization between the Arab Countries 6.3 Implementation of the Common Arab Guidelines 7- Reporting of Adverse Drug Reactions (ADRs) 7.1 Spontaneous reporting of ADRs 7.2 Individual Case Safety Reports (ICSRs) 7.3 Who should report? 7.4 Role of MAHs in reporting ADRs 7.5 What should be reported? 7.6 Characters of a good case report 7.7 Seriousness of ADRs 7.8 Expectedness of ADRs 7.9 Workflow of reporting & Reports Managing 8- How to build a powerful & an interactive Pharmacovigilance Department in your company. 9- Departments involved in Pharmacovigilance activities 10- What are the benefits of these reports for the patients and the HCPs? 11- Is the Pharmacovigilance objective is to withdraw Medications? 12- Vital & practical examples of the practical implementation of Pharmacovigilance and its impact on the public health. 13- What is next?