Introduction to Pharmacovigilance (eLearning)
Pharmacovigilance (PV) is governed by strict regulatory and legislative standards and guidelines, and subject to regular audit and inspection. Consequences of non-compliance would include, but are not limited to, financial penalties, imposed limitations on/withdrawal of marketing authorisations, and most importantly a potential risk to public health.
This in-depth 90-minute eLearning module is based on RSSL’s popular Introduction to Pharmacovigilance 1-day tutor-led course. Through self-directed study, learners will gain a comprehensive overview of the principles of pharmacovigilance; a key function in all pharmaceutical companies to ensure continuous oversight of the benefits and risk of medicines, and the early identification and management of safety concerns.
The course is suitable for anyone in the pharmaceutical industry that needs to gain knowledge of pharmacovigilance and drug safety. This could include those working in a pharmacovigilance and drug safety role that are new to pharmacovigilance, or those in a junior role wishing to gain more knowledge and understanding.
This course is also very relevant for Trainee QPs and those working in quality assurance, regulatory or medical roles who need to understand the basic principles, as well as start-up pharmaceutical companies with product/s currently at clinical trial stage with a need to understand pharmacovigilance/drug safety prior to gaining a MA license.
This course covers the following key topics:
What is pharmacovigilance?
Pharmacovigilance Legislation
Systems
Inspections and audits
Safety reports, studies and signal management
Risk management and adverse events
Additional monitoring, safety communication and Risk Minimisation Measures
Additional guidance including regulatory guidance and advisory body guidelines for UK and Ireland
At the end of the course, delegates will have:
An understanding of pharmacovigilance/drug safety (background, definitions) and its importance in promoting patient safety
Knowledge of the legislation/regulations/guidelines governing pharmacovigilance and consequences of non-compliance
An understanding of what constitutes an adverse event/adverse drug reaction/safety information
High-level knowledge of key aspects of pharmacovigilance operations and how this contributes to ensuring the timely mitigation of potential risks to patient safety
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
