|
Pope Woodhead has a wealth of experience in creating
and implementing risk management plans (RMPs) which are key to
marketing approval: EU-RMPs in Europe; and Risk Evaluation and
Mitigation Strategies (REMS) and Pharmacovigilance (PV) Plans
in the US. We will work closely with you, using our expertise
to ensure a successful outcome.
| We offer: |
| • |
Expert evaluation of the risks
and benefits of your product |
| • |
Pragmatic and innovative solutions to address
these risks, and to meet your safety, regulatory and commercial
objectives |
| • |
Synthesis and updates of EU-RMPs and US
REMS/PV plans |
| • |
Close collaboration with your product team,
including participation in health authority meetings such
as FDA advisory panels and EMEA/national regulatory authority
discussions |
| • |
Detailed planning on how your company can
successfully implement the commitments described in the RMP. |
| Recent projects: |
| • |
'Global' RMP for a cardiac
drug, which was customised into US and EU plans, with
participation in key FDA and EMEA meetings |
| • |
US PV plan and REMS for a biological
treating a metabolic disorder |
| • |
Successful revision of a risk management
approach for an anti-infective and support for regulator
interactions, resulting in regulatory acceptance after
the company's own EU-RMP was rejected |
| • |
REMS for an enzyme product in the
US |
| • |
EU-RMP for a combination product in
dyslipidaemia. |
|
|
