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The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams

A historical reminder of the importance of Regulatory Affairs in Medicines Development

Hot Topics in Medical Affairs

A historical reminder on the importance of Regulatory Affairs in Medicines Development

As the IFAPP Academy is gearing up for students to start Module 5: Regulatory Affairs, Drug Safety, and Pharmacovigilance we are reminded of the importance of these regulatory bodies and the need for continued oversight in medicines development.  The FDA emphasizes this with a short video about what can happen when medicines are not being properly regulated.

https://www.youtube.com/watch?v=mrYFbPf5qsM

Want to learn more about medicines regulations within medicines’ development?

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.

Do you know what PRIME is?

Hot Topics in Medical Affairs


Do you know what PRIME is?

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


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.

    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.


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.


Importance of Big Data for Medical Affairs Professionals

Hot Topics in Medical Affairs


The Importance of Big Data for Medical Affairs Professionals

How harnessing the power of big data can give Medical Affairs Professionals the strategic edge.



The most competitive companies in pharma must inundate themselves with data to navigate and excel in an ever increasingly complex environment. But, according to Bain & Company, companies have difficulty explaining the science and data to stakeholders in an effective and meaningful way.1 Just imagine a chemical engineer trying to explain chocolate milk to a 3-year-old. According to Bain research, this shortfall is one attributing factor to the 50% of launches that fail to meet company expectations.

So how does a company manage this problem without losing sight of their main goal, the resulting product? This is where a Medical Affairs Professional comes to the rescue. The ability for a Medical Affairs Professional to collect, analyze, interpret and present data can help ensure the success of a company.

Why is big data so important? Drug development has become more focused on narrower and more personal indications resulting in a more involved treatment. This trend, along with rising costs, and a greater multiplex for physicians to navigate has left a gap that leading companies are filling with medical affairs teams to help them translate their data in a way that physicians, payers, and providers can understand. While the company can focus on their products, they can leave the Medical Affairs Professionals to sort and distribute their big data in a valuable, effective, and consumable way.

Want to learn how to leverage company big data throughout the drug development process?

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.

To read more about big data in the world of Medical Affairs please check out this great article from Bain & Company: Reinventing the Role of Medical Affairs.

 

References:

  1. Plantevin L, Schlegel C, Gordian M. Reinventing the Role of Medical Affairs. Bain & Company. http://www.bain.com/publications/articles/reinventing-the-role-of-medical-affairs.aspx. Published March 15, 2017. Accessed January 11, 2018.