REMS a cross departmental challenge for drugmakers says PPD

By Gareth Macdonald

- Last updated on GMT

Related tags: Management, Pharmaceutical drug

REMS a cross departmental challenge for drugmakers says PPD
The US FDA’s risk evaluation mitigation strategy (REMS) can be a challenge for pharmaceutical companies unfamiliar with the process according to PPD’s executive director of risk management Frank Gallo.

Gallo told Outsourcing pharma that, while they allow drugs that would otherwise not reach the market to do so, REMS require the development of an effective strategy and considerable inter-departmental collaboration for successful implementation.

He went on to explain that one of the biggest hurdles pharmaceutical firms face is deciding how medical, legal and commercial departments will collaborate as all are stakeholders in REMS development.

Beyond this, Gallo continued, designing the REMS so that it meets both patient safety and commercial goals is a significant undertaking.

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