Complex Risk Minimisation Measures

Lisa Hughes shares her thoughts on complex risk minimisation measures in this follow up article on risk management.

“During my time working in the pharmaceutical industry I have worked on a vast range of generic and branded medicines some of which have required complex Risk Minimisation Measures (RMMs).

There are several reasons why a product may have complex RMMs, these include:

·       the number of materials and/or format needed to be created (e.g. electronic/digital/hard copy)

·       the distribution route required (e.g. website/mail drop/in pack)

·       the target audience (e.g. patients/carers/HCPs – general or specific speciality)

·       the creation of a system to monitor the risk involved (e.g. Pregnancy Prevention Programme/extended follow-up questionnaire)

·       MHRA inspections of the system (e.g. pre- and post-launch approval)

·       a combination of the above.

I have been fortunate (some may say unlucky) to have been involved in all of the above types of complex RMMs, with my biggest achievement being the creation, implementation and maintenance of the Pregnancy Prevention Programme for generic thalidomide, lenalidomide and pomalidomide. During the early days setting this system up I had many meetings with the MHRA to ensure the requirements were being met, I will always remember one assessor telling me ‘if you can set this up all other RMMs will be easy’. He was right.

If you need support for any Risk Minimisation Measures no matter how simple or complex, please reach out to us at PharmaGuard Consultancy Ltd. My partner Jackie and I have a great deal of experience that we would love to share with you and support you in achieving your company goals. Contact us via the website form or email us at info@pharmaguard.co.uk”