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Multiple international regulations will play a crucial role in the achievement of pharmacovigilance objectives. While this is an excellent opportunity to work together with global neighbors, it brings on a particular skill set to synthesize the different laws and guidelines.
FREMONT, CA: Good pharmacovigilance practice is undoubtedly different in the 21st century. When discoveries of new vaccines, medicines, and biologics spread at the pace of light, industry leaders are forced to keep up. They are therefore continually faced with the tremendous growth of pharmacovigilance as a distinct discipline.
The role of consultants and contracted resources in ensuring Good Pharmacovigilance Practices (GVP) compliance include:
Meeting Specialized Work Requirements
It is no longer a matter of merely exploring, reporting, and resolving adverse events. On the contrary, it involves the nature of the research, outcomes, product labeling, and data mining. The information collected will (and should) include hospitals and clinicians. Essentially, it is about having real-world information. Specialized consultants may satisfy the need generated by modern research called pharmacovigilance in the 20th century.
Their experience covers the study of safety signs, the drafting of case studies, data mining, and even literature reviews. According to the FDA's Guidance on the GVP, the identification and correct interpretation of 'safety signals' is a huge part of successful pharmacovigilance. 'Safety signals' are described as an excess of adverse effects compared to what would be anticipated of that particular product. These findings are accompanied by the production of 'case reports' and 'case series.' The procedure is lengthy and time-consuming, but the FDA mandatory reporting regulations mandate the detection of adverse events.
Navigating Multiple Regulatory Environments
Multiple international regulations will play a crucial role in the achievement of pharmacovigilance objectives. While this is an excellent opportunity to work together with global neighbors, it brings on a particular skill set to synthesize the different laws and guidelines. It is also imperative to know that rules are not the same. For instance, post-approval safety studies in the EU are handled very differently from the US (where the closest parallel would be post-market requirements). A well-trained, professional specialist can help managers decide the regulations that should take precedence and for what reason.
An enterprise may find it appropriate to plan for an audit of the GVP either due to internal quality management decisions or due to external requirements. Any contractor must be well versed in international legislation (not just the FDA) and have a range of best practices informed by fieldwork.