The Good Pharmacovigilance Practice (GVP) modules and other drug safety regulations set out exacting standards for you to meet without exception and the quality documentation required for your systems and activities is extensive and specified in GVP Module I. Due to the level of complexity, most companies find they face challenges e.g.:
Accurately & adequately interpreting the regulations
Applying them appropriately
Creating appropriate systems that will meet with regulators’ approval during inspections and auditing
Maintaining those systems in accordance with regulations
You could outsource these operations in their entirety to an external pharmacovigilance services provider such as PrimeVigilance. An expert team working on your behalf eliminates the risk of non-compliance – avoiding difficult and costly penalties by the regulatory authorities.
However, there are those companies who understandably prefer to complete this essential work in-house. The risk they run is that the laws are so complex and detailed that staff are unable to allocate adequate time to keep abreast of the current laws and the changes to them that inevitably come with time.
Why Choose PrimeVigilance?
Our expert consultants can show you the ‘middle way’. All are drug safety professionals with many years of experience in the field. Some have helped to draft the regulations themselves and some have been on regulatory bodies. All are highly adept at working directly with companies to ensure you always:
Meet your legal obligations
Follow current best practice
Work in the most cost effective way possible
Many of our clients choose the Primevigilance ‘middle way’, keeping operations in-house yet drawing on our support for specific tasks as the need arises. From help formulating your Standard Operating Procedures (SOPs) through to help to build your drug safety department itself, our team are right behind you. For us, Process Development means a supportive third party to develop your vital processes in a more intelligent, advanced and insightful way.
Why Use Our Pharmacovigilance Process Development Services?
There are many reasons why working with PrimeVigilance can streamline your operations, making them more time- and cost-effective. For example, GVP VI states that literature searching should be conducted weekly for adverse drug reactions. However, you need to know precisely how to conduct those searches – since explicit guidance is not contained within the Annexes. GVP Module VII provides another good example. It describes the objective of searching in broad terms without any operational guidelines to ensure a consistent approach across the company and, hence, your consistency is drawn from your SOPs. However, formulating those is time consuming and requires a process of iterative compilation.
PrimeVigilance consultants assist with process mapping and process development for documents such as these. We offer a comprehensive suite of template Standard Operating Procedures in relation to clinical trial and post marketing pharmacovigilance and risk management. All are designed to be specifically adapted to your precise requirements. Whereas preparation of SOPs de novo can take many weeks and represent a considerable investment of your resources, our templates can result in significant time and cost savings.
Our approach works for individual SOPs and operational guidelines; it works for whole suites of SOPs and it even works where you need an entire Drug Safety Department to be built from scratch, including taking care of your needs for:
An EEA Qualified Person for Pharmacovigilance (QPPV)
Suitably skilled personnel for literature screening
A system to receive events and process them
A safety database
A Pharmacovigilance System Master File (PMSF)
Safety Data Exchange Agreements (SDEAs)
Primevigilance’s Process Development is the process by which each of these elements is meticulously planned and organised to help you define your needs and provide you with expert advice on how to proceed at every stage. We can also produce your SOPs and other operational guidelines so that your staff always have clear and consistent instructions to follow for each process – ensuring that all your operations stay completely compliant. Finally, you may prefer to have PrimeVigilance handle the work in its entirety as your named contracted comprehensive drug safety services provider. To find out more about how our team can help yours, simply call us today in confidence on +44 (0)1483 307920.
Pharmacovigilance Process Development – documented and compliant