Risk Management Plans

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It is obligatory to provide, as part of a Marketing Authorisation Application (MAA):

"A detailed description of the pharmacovigilance and, where appropriate, the risk-management system which the applicant will introduce."

Akos can advise on the extent of the proposed risk management system and how far the EU template would need to be completed.

Uniquely; owing to our Pharmacovigilance business unit Akos is also able not only to design but implement a full risk management system.

As the Risk Management Plan is part of the Common Technical Document it is also required as part of a New Drug Application (NDA) in the US.

Akos can execute all aspects of the risk management proposals:

  • Risk assessment
  • Pharmacovigilance plan
  • Risk Management Plans (RMP) - (EU)
  • Risk Minimisation Action Plans (RiskMAP) - (US)
  • Risk Evaluation and Mitigation Strategy (REMS) (US)

To discuss your regulatory questions with Akos please contact us:

Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk