Risk Management Plans / Risk Evaluation and Mitigation Strategies

Risk Management Plans (RMPs)

Following on from ICH E2E and Module V of the EU Regulations, the requirements for a Risk Management Plan to accompany licence submissions is now fully mandated in Europe whether the product is generic or an innovator product. PharSafer® has written and continues to write both RMPs for generic products as well as for innovator products.

Additionally, for clients, PharSafer® has helped maintain the RMPs both for generic and innovator products and has also registered and maintained the RMP on Annexe 1.

PharSafer® has written RMPs for generic products, innovator which has included drug-device combinations; products with more than one active (fixed combination products); RMPs with minimisation activities; RMPs with associated registries; Biologic products; and across many therapeutic areas including respiratory; oncology; gastrointestinal; neurological; anti-infective; and anti-inflammatory.

Some of the RMPs produced also link to the REMs (see below) we have implemented for our US clients as well where a joint launch of the product in the USA and Europe has resulted in similar approaches regarding Risk assessment and monitoring.

All RMPs produced and submitted by PharSafer® to the Agencies to date have been approved. This includes both submissions to the EU and Japan. PharSafer® has also written supportive educational material for Healthcare professionals and developed FAQs for Medical Information Departments associated with the Risk activities to provide a seamless solution to risk monitoring for the client product. PharSafer® has been involved in RMPs since 2008.

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Risk Mitigation and Evaluation Strategies (REMs)

The FDA interpretation of the ICH E2E Pharmacovigilance planning resulted in the production of the PDUFA III documents which included the use of REMs to reduce the risk elements associated with the Company product. These types of activities ranged from educational material, to more interventional methods of product restriction, routine patient testing as well as monitoring the progress of the various schemes themselves to ensure maximum efficiency in having robust systems in place.

PharSafer® has engaged in the assessment and amendment of such REMs to improve the current levels of success in reducing patient risks. We have been involved in such schemes since 2010.