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How to Establish a Solid PV Training Curriculum?

Posted on April 5th, 2017 by in Pharmacovigilance


There are many elements to consider when you develop a training curriculum for your PV team. A training curriculum defines which roles (rather than individuals) in a group should be trained on which processes. Here are some elements to consider if you want to maximize your training efforts in order to be efficient, compliant and inspection-ready.

PV training is not just about PV SOPs.

All PV individuals should be trained on Standard Operating Procedures (SOPs) or Work Instructions (WIs) that are directly relevant to their daily activities. The documentation of such training is obviously key during an inspection. Beyond training on PV-related quality documents, the curriculum should also include applicable regulations and guidelines.

There is no Equality in Training.

A one size fits all approach for all PV roles does not work. Carefully designing the training program according to each role will be more impactful and avoiding wasting precious resources. Operational roles should focus on SOPs and WIs applicable to the daily work; leadership roles should have more executive-level training on selected, high-level SOPs and Policies. A specific and well-designed training matrix will reinforce the feeling of belonging to a smart organization, will increase motivation and will reduce the human and financial impact of hours spent on irrelevant training.

Not all SOPs are about PV.

Very often the PV training curriculum includes too many training requirements on processes which are only remotely connected to PV. This gives a false sense of security and will not minimize the risk of deviations and inspection observations. Time is a limited and costly resource. It is better to use this precious resource on relevant process rather than to force individuals to fly through irrelevant training on processes they will never use. The piling up of SOPs seen in many organization is costly, inefficient and demotivating. Do you think the following statement applies to you: “I am trained on quality documents which are directly relevant to my role, and I am not asked to be trained on quality documents describing processes that I will never (ever) use”?

 How You Train Will Make a Difference…

Read and sign is the easiest but lousiest approach to train individuals, when the fundamental objective of any training program should be ensuring that activities are completed in a consistent and compliant manner as defined by best standard practices. Slide decks, interactive web based material or face to face training should be the gold standard in place. All training knowledge should also be tested by a system that prevents circumventing the process. Try saying the following: “I have never been multitasking while listening distractedly to a long and tedious corporate mandatory training session”…

A Few Other Points.

All training documentation, CVs and Job Description should be stored electronically to facilitate regular review and accessibility during an inspection or audit. If possible, the company Learning Management System should be a repository for all training supporting documents, training documentations, internal or external (seminars, congresses).  A qualification program should be set up for new hires, including shadowing activities, coaching and monitoring the correct execution of tasks before the new hire is certified to fulfill the role. This will ensure that individuals are both trained and qualified to do their job.

Implementing the right training program for your PV team will have important short and long term consequences. In an era of activities overload, distractions and multitasking, training should be specific, attractive and impactful. Companies living and breathing quality and learning are the ones who will thrive, because of the increased engagement, job satisfaction and overall compliance. Training is a serious investment, deserving preparation, resources and attention. Patient safety requires it.

JP Clement

Elsevier recommends:

View our complimentary,  pre-recorded webinar, Introducing QUOSA PV to Embase, where you will be introduced to the new QUOSA PV tool and see a demonstration of how it benefits Embase users.  QUOSA PV helps centralize and automate the process of reviewing literature for adverse events.   View here.


All opinions shared in this post are the author’s own.

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J.-P. Clement MD

Executive Pharmacovigilance Consulting

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