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Development risk management:
– characterises risks as they arise during development
– determines pre-launch actions to further evaluate or mitigate
these risks
– considers implications for the post-marketing environment.
Pope Woodhead is currently working with a number of clients on
developmental risk management plans (DRMPs).
The DRMP documents this analysis over time and
naturally evolves into the RMP required for filing. The DRMP also
supports meetings with regulators, drives updates of key documents,
e.g. the Investigator’s Brochure (IB), and aids strategic
decision-making.
| We offer: |
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Expert evaluation of the emerging
risks and benefits of your product |
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Synthesis of a DRMP document that suits
your team's needs |
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DRMP updates at appropriate intervals throughout
the development lifecycle |
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Design and implementation of developmental
risk minimisation and pharmacovigilance activities |
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Creation of a customised process to embed
developmental risk management within your organisation |
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An on-line 'living' DRMP that enables your
team to easily share current risk information. |
| Recent projects: |
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Ongoing DRMP started during
phase I for a Type II diabetes product |
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Ongoing DRMP started at phase II entry
for a cardiovascular drug, leading to an innovative
risk mitigation tool for mid-stage trials |
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Ongoing DRMP started early in phase
III for a CNS treatment, which has driven the safety
approach during late-stage trials. |
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