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PP01-05: Converting EU-RMPs to the GVP Module V Rev 2 Format: Impactful Results and Lessons Learned

Poster Presenter

      May Chan-Liston

      • Senior Pharmacist
      • FDA
        United States


To review the results of the Risk Management Plan (RMP) template conversion to Revision 2 format for Celgene products and the impact of recategorizing safety concerns by March 2018 with the aim to create a risk-proportionate RMP.


Data gathered over time from Post Authorization Safety Studies (PASS) to further evaluate and characterize the safety profile in addition to spontaneous post-marketing surveillance data provided the best approach for quantification and qualification of risk.


In March 2017, the European Medicines Agency updated its good pharmacovigilance practices (GVP) Module V – Risk Management Systems to Revision 2 including the RMP template. The evolution of the risk profile throughout a product’s life cycle is an integral part of the new guidance. Updated guidance ensures that the RMP is more risk-proportionate regarding important identified risks, important potential risks, and missing information. European Medicines Agency (EMA) consulted with Celgene to obtain feedback on the new guidance. The conversion of RMPs resulted in the reduction of safety concerns for each EEA-approved Celgene product. Although the concept of an important risk remains unchanged, the revision places a greater emphasis on a risk-proportionate approach for defining a product’s safety profile. The safety concerns in aggregate reports such as PSURs may differ from this new approach. Table 1 shows the reduction of safety concerns for converted RMPs. Challenges included compliance with regulatory deadlines, transcription of data into a new format, data integrity of evidence on existing safety data, and incorporation of new safety data for critical review by EMA for re-classification of risks. Table 1: Reduction in Safety Concerns in Revised RMP Format Product |Safety Concerns in RMP |Safety Concerns in Revised RMP |Reduction in Safety Concerns Azacitidine N=21 N=2 90% Lenalidomide N=26 N=8 69% Nab-paclitaxel N=25 N=0 100% Pomalidomide N=24 N=7 71% Thalidomide N=24 N=7 71%


EMA consulted with industry leaders in a pilot program on revising GVP Module V. Celgene was amongst a group of pharmaceutical companies that engaged in these discussions which led to an update on the intent and content of the risk management plan to ensure patient safety. The revised format sets a new tone in a pragmatic approach to risk management. A major update to the revised guidance on RMPs relates to criteria considered for characterization of the important identified risks, important potential risks, and missing information. The summary of safety concerns is accurately defined and assists the prescriber and patient to better understand the risk profile of the product, especially when they impact additional educational materials such as healthcare professional brochures and patient alert cards. The risk profile will continually change throughout the product’s lifecycle as safety data emerges. Risks included in the initial MAA can be seen critically and causal associations to the medicinal product can be deduced. Additional risk minimization measures and pharmacovigilance activities may also change along with corresponding changes to the risk profile. Additional pharmacovigilance activities can be modified as safety information pertaining to important risks and missing information is fully characterized. By June 2018, Celgene was among the first pharmaceutical companies to update its RMPs into the new format. This important initiative has enabled companies to succinctly and effectively communicate current risks and relevant safety data in a risk-proportionate manner.

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