The processes required for each of these activities are described in depth in the various modules of the guideline on Good Pharmacovigilance Practices – for example, in GVP Module IX, Signal Management and Module VII, Periodic Safety Update Reports.
For new products and those with new therapeutic indications, dosage forms etc., there are requirements for companies to prepare a Risk Management Plan, in accordance with EU regulations and using a specific template. The Risk Management Plan includes a Safety Specification, a Pharmacovigilance Plan and Risk Minimisation action plan. The Safety Specification states what is known for the product in terms of drug safety, as well as what is uncertain and what important safety information is still needed. Thus, it describes the important ‘identified risks’, ‘potential risks’ and ‘missing information’ for the product.
The Risk Management Plan describes the pharmacovigilance system and, for each identified and potential risk and item of missing information, states whether routine pharmacovigilance activities will be sufficient or whether additional activities (such as post-authorisation safety studies) are needed to fill the gaps in the knowledge about drug safety. These considerations are all described in depth in the Pharmacovigilance Plan section of the Risk Management Plan.
For each ‘important’ identified and potential risk, the Risk Management Plan indicates whether the company proposes routine risk minimisation activities – such as statements relevant to drug safety in the product information – or if additional activities are required, such as educational programmes for prescribers, patient support schemes, etc. In each instance, the company has to specify how it will monitor whether the efforts to minimise risk actually work in practice.
The routine monitoring of benefits and risks of a product may generate new signals and safety concerns which then lead to an updating of the Risk Management Plan for the product. Signals are also described in the PSUR and any changes to the drug safety profile of the product any new information regarding its benefits are considered in detail in that document. Complying with the requirements of the guideline on Good Pharmacovigilance Practices for a critical integrated benefit risk evaluation can be a challenging exercise for any pharmacovigilance department.
The fulfilment of this regulatory obligation activity is routinely inspected by regulatory authorities and it requires a systematic approach, with robust processes and involving experienced pharmacovigilance personnel: PrimeVigilance has the necessary expertise and experience for this activity. Effective monitoring of benefits and risks is also a form of “life insurance” for companies, prescribers and patients: if there are indeed problems with drug safety these need to be identified and addressed at the earliest opportunity. The critical evaluation of benefits and risks within companies may be contentious and identifying appropriate strategies difficult: at such times it can be invaluable to have access to top flight independent expertise which PrimeVigilance can also provide.
For more information contact PrimeVigilance today
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(+1) 781 703 5540
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