Scope of the training

This training course will describe internationally accepted principles, practical approaches, and regulatory expectations for a company’s pharmacovigilance quality management system. The topics will cover organizational structure, responsibilities, processes and resources required for the pharmacovigilance (PV) system and its quality system based on ISO and ICH requirements. The course is designed for pharmaceutical professionals in the early phases of developing and improving a quality system. This includes what it means to be inspection ready and how to respond in and after an inspection. As well as a thorough theoretical grounding in the subject, there will be practical exercises such as how to write a good quality SOP and how to conduct and perform during an inspection or audit. All of this will be adapted to the current regulatory environment in Egypt.

What will the delegate expect to learn in this course?

At the conclusion of this course, we aim for delegates to be able to:

• Understand features of a quality system which underpin all GXP activities and differences between a quality management and pharmacovigilance audit?
• Describe how to design, develop, and manage a quality system related to your pharmacovigilance system which is fit for purpose in Egypt in the context of a global pharmacovigilance quality system.
• Explain and describe the components of pharmacovigilance system master file and how this document provides both a foundation for the quality system but also acts as an important tool for inspection readiness.
• Analyse and improve processes for the development, maintenance, and quality oversight of pharmacovigilance SOPs and pharmacovigilance related documents, including Pharmacovigilance Agreements all phases of the life cycle of a medicine
• Better arrange plans for risk-based audits of the quality system including the variety of different audits needed such as those for business partners and vendors.
• Organise preparations are for audits and inspections, preparing responses and corrective and preventive action plans.

WHO WILL BENEFIT FROM ATTENDING?

This program is designed for pharmaceutical and regulatory professionals involved in:

• Quality assurance and compliance of the pharmacovigilance system
• Pharmacovigilance auditors
• Qualified persons for pharmacovigilance and their deputies
• Pharmacovigilance personnel responsible for compliance, training, pharmacovigilance agreements, and/or pharmacovigilance quality documents