Pharmacovigilance Training Online
Choose from 4 GPvP Online Modules
Mr Steve Jolley is a Cambridge University graduate with over 25 years’ experience in drug safety & pharmacovigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signaling.
Pharmacovigilance monitors the safety of a drug once it has been launched onto the market. It is the process which improves the safety of medicines. It detects medicines that cause serious adverse drug reactions (ADRs) and ensures they are re-evaluated or removed from the market to protect public health.
UK inspectors have rights conferred under the Medicines Act 1968 sections 111(1 to 3) and 112 (1 to 4 and 7). These include the right to enter any premises covered by the Act to carry out inspections, and take copies of Pharmacovigilance compliance documentation. In the US, if the FDA is unsatisfied with an inspection, they have powers to seize product, issue sizeable fines and even launch criminal proceedings.
Our course certificate enables you to quickly demonstrate that your staff has undergone the appropriate training and helps show that your company has appropriate pharmacovigilance systems in place.
Depending on location, different legislation governs adverse drug reaction reporting within clinical trials and under post-marketing conditions. For example pharmacovigilance within clinical trials is governed by Directive 2001/20/EC - Volume 10 in the EU, by 21 CFR 312 (IND) in the US and by ICH E2A (Clinical Safety) and ICH E2F (DSUR) globally. But in all cases, the relevant regulatory body can carry out inspections of trials as well as marketing authorisation holders (MAHs) to ensure the correct systems are in place to capture and report adverse drug reactions.