Risk Management

FDA’s (FDAAA/REMS) and EMA’s (EU-RMP) increased focus and guidance for industry on post-marketing safety surveillance and risk minimization has resulted in a significant increase of risk management programs and mandated post-marketing requirement studies. MakroCare provides Sponsors the following risk management design, implementation, and support services:

  • Risk management consulting
  • Design and execution of risk management interventions includes
    • Risk evaluation and mitigation strategies (REMS)
    • European Union risk management programs (EU-RMP)
    • Performance linked access systems (PLAS)
    • Post-marketing requirement studies

EU-RMP
European Risk Management Plans (EU-RMP) are required for all products submitted for registration in the European Union. These are written documents that outline the product risks, the post-marketing surveillance plan and the risk minimization activities.

We have expertise in working with sponsors to develop these plans to meet the needs of regulatory agencies in Europe. We also provide support for the development and maintenance of these documents as part of required periodic updates to the European regulatory authority (EMA).

REMS
REMS is a component of Title IX of the FDA Amendments Act (FDAAA) passed in September 2007. A REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor.



Considerations for REMS for new drugs or biologics include:

  • Size of the population likely to use the drug
  • Seriousness of the disease or condition indicated for the drug
  • Expected benefit of the drug with respect to such disease or condition
  • Expected duration of treatment with the drug
  • Seriousness of any known or potential adverse events associated with use of the drug
  • Whether the drug is a new molecular entity or not ?

Elements to assure safe use as defined in FDAAA include:

  • Healthcare providers who prescribe the drug have particular training or experience, or are specially certified
  • Pharmacies, practitioners or health care settings that dispense the drug are specially certified
  • The drug is dispensed to patients only in certain health care settings, such as hospitals
  • The drug is dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory test results
  • Each patient using the drug is subject to certain monitoring
  • Each patient using the drug is enrolled in a registry (see section 505-1(f)(3) of the Act)
  • To assure safe product use regulatory agencies may mandate controlled distribution or a PLAS to link product access to laboratory testing results or other documentation