Good Pharmacovigilance Practices (GVP) Compliance training offers industry guidance on good pharmacovigilance practices and pharmacoepidemiologic evaluation of observational data on pharmaceuticals, including biological drug products (excluding blood components).
It specifically guides on:
- Safety signal identification
- Pharmacoepidemiologic safety signal interpretation, and assessment
- Pharmacovigilance project development
Why is pharmacovigilance important?
The World Health Organization (WHO) defined Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”.
WHO specifies that any newly developed drug must meet three critical conditions before approval by its respective regulatory agency?
- Good quality
- Safety for intended purposes
Pharmacovigilance (PV) is central to drug safety. PV analysis conducted in Phase I, Phase II, and Phase III clinical trials gives the drug company’s data on the safety profile of the drug. This data can be used for additional research and development (R&D) if necessary, or it can be submitted to regulatory authorities to gain access to new markets.
In clinical research, PV offers valuable insights into the safety profile of pharmaceutical drugs, both by manufacturing methods and by medical professionals and consumers.
When a new adverse reaction in a drug is recognized, the label’s list of side effects must be up-to-date. PV data can sometimes result in the removal of a drug from the market (drug recall) due to dangerous side effects. The main objectives that Good Pharmacovigilance Practices (GVP) compliance applicable to pharmaceuticals are:
- Promoting the safe and effective use of pharmaceutical products, particularly by providing timely information about the safety of medical products to patients, healthcare professionals, and the general public
- The terms of marketing authorization or occupational exposure, preventing harm from a negative response in humans, arising from the use of authorized medicinal products within or outside.
Pharmacovigilance activities are organized by separate but connected processes, and each GVP module presents one major pharmacovigilance process. Additionally, GVP provides guidance on the conduct of pharmacovigilance for specific product types or populations in which medicines are used. These GVP considerations must be used in conjunction with the process-related guidance provided in the modules.
What do the training courses on Good Pharmacovigilance Practices contain?
Good Vigilance Practices Compliance courses deal with:
- The basics of good pharmacology and current legal rules and regulations
- Outlining the main GVP requirements for pharmacovigilance and risk management systems
- The essential documents related to GVP and understand the essence, purpose, and structure of important case-related files such as the Pharmaceutical System Master File (PSMF), Periodic Safety Update Report (PSUR) and Study Protocol.
Why is e-learning the best strategy for GVP Compliance training?
Good Pharmacovigilance Practices Compliance training is very useful for employees particularly in the field of drug trials. Elearning can enhance this training by the use of the following strategies:
1) Micro learning
Micro learning can defined as a targeted short course, with a piece of content, or task (not more than five to ten minutes) that focuses on a single learning objective. Micro-learning is a very effective form of learning as they focus on one topic at a time, decreasing load on the learner. It might be in the form of a single concept or scenario, infographics or interactive PDF, a short educational or instructional video or animation, or a brief webinar.
The concept of GVP Compliance is vast and consists of various topics that can be lengthy. With micro learning, you can divide these topics into chunks of smaller modules that can be grasped easily.
2) Scenario based learning
Scenario Based Training changes the learning experience from passive to in-depth. The employee can interact with the course, by making real-life decisions in a risk-free environment, and understand the consequences of their decisions through constant feedback.
In Pharmacovigilance, an individual can experience different scenarios where his/her decision can be very crucial during documentation and verification of drug safety. Hence Scenario based learning can be of help during the training on GVP compliance.
3) ILT/VILT conversion to eLearning
Converting your ILT and VILT to eLearning courses is a quick and inexpensive process of providing training on an existing content. In an Instructor Led Training (ILT) the training takes place in the presence of a trainer and facilitator who guides a group of learners through a session either in a classroom or virtually. In this, your existing digital assets, content, and learning strategies can be transformed into effective virtual eLearning courses in a remarkable short time frame.
4) Simulation-based training
Software simulations can help in training on the software tools required in pharmacovigilance researches by providing an immersive software experience for the learner to learn the different aspects of a software and receiving feedback.
5) Translation and localization
With the use of translation and localization services of eLearning, you will be able to provide training in different languages, enabling you to reach a wider range of audiences.
The workforce at Pharmacovigilance firms is usually diverse, with people from different cultural and ethnical backgrounds. Translating courses to the language they are comfortable in, helps in better engagement during training.
6) Tracking employees compliant
eLearning when combined with the LMS platform, makes it easy to track the performance of your employees and have a documented data on the progress of their training.