Quality training is ultimately a compliance issue. The current guidelines on Good Pharmacovigilance Practice clearly emphasise the link between meeting regulatory quality standards and having adequately trained personnel1. Modern drug safety practice relies on professionals who are fully versed in all the relevant processes and regular communication between those professionals and relevant third parties such as regulatory authorities. There is an expectation that well trained employees should be constantly updated with appropriate continual professional development. Training must be appropriate to the role to which employees are fulfilling and competency assessment should be undertaken to ensure understanding.The commitment to the highest quality training should be a prime driver within all company activities in this arena.
Professionals are expected to demonstrably acquire and maintain:
• An appropriate level of qualification.
• A thorough working knowledge of pharmacovigilance obligations in relation to their particular role and how that relates to the overall processes.
• The working knowledge of how to practically respond to issues of drug safety concern.
There must also be a commitment to training for employees who are not directly placed within acompany’s pharmacovigilance unit, but whose work has a direct relationship to it. Examples here could include diverse professional teams such as sales staff, legal team andcustomer services personnel dealing with certain types of complaints, etc. Please note this list is not exhaustive but serves to illustrate the wide scope of need for high quality training on an ongoing basis. Furthermore, there should always be checks and balances in place to ensure that the training everyone has received meets their operational needs.
PrimeVigilance consultants are among the world’s leading pharmacovigilance educators. They have trained company employees and regulators in many countries on basic and advanced aspects of pharmacovigilance. They have lectured on regulatory compliance and risk management as well as offering training on MedDRA® at all levels. They have been instrumental in writing the guidelines, developing the processes as regulators, using what they teach as part of their daily work. They have lectured on these subjects at academic institutions, published papers and spoken at and chaired international conferences on all of these subjects: these are people passionate about their subject.
Whether you require aggregate report training (DSURs and PSURs), risk management workshops, Pharmacoepidemiology support, or other types of training, we can help. Our consultants can carry these out at your company locations – and they are all seasoned experts in their particular field.
PrimeVigilance can also offer inspection preparation training, with intensive courses on the regulations, advice on inspection activities, coupled with one-to-one training on interview technique for all your inspector-facing employees1. Additionally we offer back room support during inspections. But we can do more; by educating senior management on how effective pharmacovigilance is life insurance for your Company.
By bringing these educational activities to the Company premises the need for expensive and time-consuming travel for employees is reduced and can be at a low cost per trainee.
1. Preparing for a European pharmacovigilance regulatory inspection. Brown EG. Pharmacoepidemiol Drug Safety 2002 11 S238
+44 (0)1483 307920
(+1) 781 703 5540
United Kingdom (Head Office)