Named-Patient and Compassionate Use Programs
WHAT IS A NAMED PATIENT PROGRAM?
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A Post-Approval Named Patient Program (PA-NPP) affords patients and physicians access to commercially approved medicines that are not yet accessible to them in their own country. It is important to note that these drugs must be approved in at least one country. If approved in at least one country, then these drugs can be imported into the patient’s country under a PA-NPP.
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A general overview of drugs that may fit this criteria, include:
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Approved but not yet commercially available to be prescribed in the patient’s particular country
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Approved and available in one country but not approved and available in the patient’s particular country
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Discontinued in the patient’s particular country for some reason, but still approved in at least one country
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Not available in patient’s particular country due to supply issues
We provide a best in class dedicated pharmacovigilance service for named-patient and compassionate use monitoring.
These specialized services include:
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Compilation and follow-up of Adverse Events (AEs) from named-patient and compassionate use programs
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Eudravigilance arrangement and management
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Drug Safety Project Management
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Electronic management of AEs on the ARISg™ database
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Electronic rushed reporting to Health Authorities
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Compliance oversight
The Gemini Group Best in Class Expert Service
Single-Source Provider
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Our mission is to improve the health and safety of patients; therefore we are business-centric and focused on delivering the uppermost quality of services throughout the full product lifecycle.
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QPPV and LPPV Services
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Our fully qualified PV subject matter experts use their extensive experience in pharmaceuticals, regulatory, and academia to deliver all-inclusive QPPV and LPPV services.
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We are Operate Globally and Understand the Various Intricacies
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Whether you need individualized PV services or dynamic and integrated global pharmacovigilance, medical information and regulatory services, Gemini Group will support your specific requirements.
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Our PV team comprises of seasoned healthcare professionals such as PharmD, Nurses, and Medical Doctors and we work as your collective partner, in support of our companies mission to improve patient health and safety.
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Contact
Let's connect. We would be delighted to offer a zero obligation consultation.
973-348-5838