Introduction

• We introduce this course for pharmacists and all health care providers, which will support all of them with updated knowledge about pharmacovigilance after careful consideration of the scientific and medical knowledge. It is designed to cover all aspects of Pharmacovigilance and drug safety management. This course is based on the European guideline on GVP, WHO and is a complete training solution for all individuals that need to acquire pharmacovigilance knowledge. Our training can also serve as a refresher course. It is consistent with the legislation changes in EU and is suitable for everyone who needs to be up-to-date with the pharmacovigilance guidelines or is involved in drug safety, pharmacovigilance, regulatory and quality compliance. This course will allow you to enjoy the learning process and easily understand the fundamentals of Good Pharmacovigilance Practice.

• In this section, we will provide in details what is in guidelines about pharmacovigilance definition, legal and ethical background then we will discus pharmacovigilance system, adverse events, the role of the qualified person responsible for pharmacovigilance, detailed description of the pharmacovigilance system, reporting of adverse reactions and risk management.

Goals and Objectives

1-Being aware with pharmacovigilance.
2-To introduce the principles of good pharmacovigilance practice, the current legal regulations and guidelines
3-Diagnosis and Management of Adverse Drug Reactions
4-The clinical management of adverse reactions
5-To have the confidence to outline the main GVP requirements related to the pharmacovigilance and risk management systems
6-Get familiar with the essential documents related to GVP and understand the essence, purpose and structure of important trial related files such as the pharmacovigilance system master file (PSMF)
7-Provide a high-end training thereby enhancing the employment prospects of the participants.