Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors – Broadening your Knowledge Training Course

Course overview

The importance of drug and medical device safety is paramount and the regulations and requirements applicable to the discipline of pharmacovigilance are extensive and complex.

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to learn next in this complex area.

It will give a comprehensive overview of all aspects of PV from global pharmacovigilance and safety standards to where drug safety fits within the company. Safety reporting, adverse reactions vs adverse events, and clinical drug safety will be addressed. It will introduce Medical Device reporting and look at both EU and FDA regulations. Pre-clinical animal and in-vitro studies will also be covered as will post-marketing drug safety. How to collect quality data and specific clinical areas such as Pregnancy and At Risk Groups will be discussed.

Overall this course will provide a thorough and extensive overview of pharmacovigilance and will equip delegates with the ability to apply the knowledge gained to enhance their role within the company.

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Benefits of attending

• Gain a comprehensive overview of all aspects of PV from global pharmacovigilance and safety standards to where drug safety fits within the company
• Address safety reporting, adverse reactions vs adverse events and clinical drug safety 
• Learn medical device reporting and both EU and FDA regulations
• Explore pre-clinical animal and in-vitro studies, as well as post-marketing drug safety
• Discuss how to collect quality data and specific clinical areas such as pregnancy and at risk groups

Who should attend?

This course is suitable for Pharmacovigilance (PV) personnel with up to 24 months of experience, looking to diversify their knowledge and expand their potential to move into different areas of Pharmacovigilance.

The course would also be appropriate for Auditors who want to understand more about PV and what to look out for when performing audits.

It would also be beneficial to Regulatory Affairs personnel who want to understand some of the pharmacovigilance activities that cross over into the Regulatory area.

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