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You are here: Home1 / Do you know what PRIME is?2 / Hot Topics in Medical Affairs3 / Do you know what PRIME is?
Do you know what PRIME is? - IfappAcademy.org

Do you know what PRIME is?

April 2, 2018/in Hot Topics in Medical Affairs /by Amanda Schmitt
Hot Topics in Medical Affairs

Do you know what PRIME is?

“Paving the way for promising medicines for patients”
European Medicines Agency

Do you know what PRIME is? - IfappAcademy.org

Many patients with serious diseases have no or only unsatisfactory therapeutic options and should be able to benefit from scientific advancement and cutting-edge medicines as early as possible.

The European Medicines Agency (EMA) developed PRIME in line with the European Commission’s priorities and the common strategy to 2020 for the European medicines regulatory network. The goal is to foster research on and development of medicines for patients whose diseases cannot be treated or who need better treatment options to help them live healthier lives.

Do you know what PRIME is? - IfappAcademy.org

    1.  PRIME is driven by patients’ need.
    2. It focuses on medicines that address an unmet medical need, i.e. offers a major therapeutic advantage over existing treatments or benefits patients with no current treatment options for their disease.
    3. It helps to translate research into the development of medicines while meeting regulatory requirements.
    4. It aims to bring promising treatments to patients earlier, without compromising high evaluation standards and patient safety.

Do you know what PRIME is? - IfappAcademy.org
Benefits of PRIME for Medicine Developers

    1. PRIME helps developers of promising new medicines to optimize development plans.
    2. It fosters early dialogue with EMA to facilitate robust data collection and high-quality marketing authorization applications.
    3. It speeds up evaluation so that medicines can reach patients earlier.
    4. It encourages developers to focus resources on medicines likely to make a real difference to patients’ lives.

This article was originally published on the EMA website. To view the full publication please visit this direct link: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2016/03/WC500202670.pdf

Want to learn more about the European Medicines Agency and its initiatives?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

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Tags: career advancement, continuing education, Continuing professional development, drug development, IFAPP Academy, medical affairs professional, medicines development, pharmaceutical medicine, professional certification, professional skills
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