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 understand next in this complex area.
2-4 October 2023
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, which features other pharmacovigilance training courses for professionals.
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.
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
2-4 October 2023
09:00-16:15 UK (London) (UTC+01)
10:00-17:15 Paris (UTC+02)
04:00-11:15 New York (UTC-04)
Course code 12816
Until 28 Aug
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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
United States of America
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: