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.
At the conclusion of this course, we aim for delegates to be able to:
This program is designed for pharmaceutical and regulatory professionals involved in:
Fairmont Nile City Hotel
For Local Participants:
1-2 delegates : 400 USD
3-4 Delegates: 300 USD
5+ delegates: 250 USD
For International Participants:
1-2 delegates: 600 USD
3+ delegates: 500 USD