Lay summaries help to provide transparency and understanding of clinical study results to the general public 2. What are the Current Regulatory Requirements? 2.1 European Medicines Agency: EU Clinical Trial Regulation 536/2014 The EMA initiated the call for the submission of lay summaries through the European Union Clinical Trials Regulation (EU CTR) 536/2014. Among other […]
“Third Strategic Pillar” of the pharmaceutical industry Learn what McKinsey & Company has to say about the future of Medical Affairs, “A Vision for Medical Affairs in 2025”. Are you ready for the future of Medical Affairs? In A vision for Medical Affairs in 2025, a new report released by McKinsey & Company, Medical Affairs is cited as […]
This article was originally published on Frontiers in Medicine. Authors: Remco L.A. de Vrueh, Jon S. B. de Vlieger, and Daan J. A. Crommelin Editorial on the Research TopicPublic-Private Partnerships as drivers of innovation in healthcare The format: from bilateral to multilateral Around the turn of the century, a rather simple classification of public-private-partnerships (PPPs) […]
This article was originally published on Frontiers in Medicine. Authors: Manuela Battaglia1, Pat Furlong2, Nico Martinus Wulffraat3, and Felicitas Bellutti Enders4 1Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy 2Parent Project Muscular Dystrophy, Hackensack, NJ, United States 3Department of Pediatric Immunology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht, Utrecht, Netherlands 4Allergy Unit, Department […]
The below excerpt is from an article originally published on the Frontiers in Pharmacology website. To check out the full article click here. The development of new medicines today, requires a multi-professional workforce, both in industry and the clinical research arena. Pharmaceutical physicians (PPs) and medicines development scientists (MDS) need a certain level of competence, […]
Lay Summaries of Clinical Study Results: An Overview
/in Hot Topics in Medical Affairs /by Amanda SchmittLay summaries help to provide transparency and understanding of clinical study results to the general public 2. What are the Current Regulatory Requirements? 2.1 European Medicines Agency: EU Clinical Trial Regulation 536/2014 The EMA initiated the call for the submission of lay summaries through the European Union Clinical Trials Regulation (EU CTR) 536/2014. Among other […]
Future of Medical Affairs: “Third Strategic Pillar”
/in Hot Topics in Medical Affairs /by Amanda Schmitt“Third Strategic Pillar” of the pharmaceutical industry Learn what McKinsey & Company has to say about the future of Medical Affairs, “A Vision for Medical Affairs in 2025”. Are you ready for the future of Medical Affairs? In A vision for Medical Affairs in 2025, a new report released by McKinsey & Company, Medical Affairs is cited as […]
Editorial: Public-Private Partnerships as Drivers of Innovation in Healthcare
/in Hot Topics in Medical Affairs /by Amanda SchmittThis article was originally published on Frontiers in Medicine. Authors: Remco L.A. de Vrueh, Jon S. B. de Vlieger, and Daan J. A. Crommelin Editorial on the Research TopicPublic-Private Partnerships as drivers of innovation in healthcare The format: from bilateral to multilateral Around the turn of the century, a rather simple classification of public-private-partnerships (PPPs) […]
Improving the Translational Medicine Process: Moving Patients From “End-Users” to “Engaged Collaborators”
/in Hot Topics in Medical Affairs /by Amanda SchmittThis article was originally published on Frontiers in Medicine. Authors: Manuela Battaglia1, Pat Furlong2, Nico Martinus Wulffraat3, and Felicitas Bellutti Enders4 1Diabetes Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy 2Parent Project Muscular Dystrophy, Hackensack, NJ, United States 3Department of Pediatric Immunology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht, Utrecht, Netherlands 4Allergy Unit, Department […]
International Perception of Competence, Education, and Training Needs Among Biomedical Professionals Involved in Medicines Development
/in Hot Topics in Medical Affairs /by Amanda SchmittThe below excerpt is from an article originally published on the Frontiers in Pharmacology website. To check out the full article click here. The development of new medicines today, requires a multi-professional workforce, both in industry and the clinical research arena. Pharmaceutical physicians (PPs) and medicines development scientists (MDS) need a certain level of competence, […]