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Medical Device Software Development: How to Build your EU/US Strategy
This webinar helps developers of e-health/m-health solutions to better understand the regulatory environment relevant to their digital technologies in Europe and in the US and how to best overcome these…
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Featured resources
presentation
Deep Dive into FDA’s Expedited Programs for Drug Development
If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
publication
Recent Revisions to Legislation Impacting the Pharmaceutical Industry in Switzerland
With the objective of harmonizing pharmaceutical regulatory practices and legislation with Europe, the Swiss Medicines Agency (Swissmedic) recently conducted an…
presentation
Overview of EU Regulatory Landscape for Regenerative Medicines
Regenerative medicines, part of the so-called Advanced Therapy Medicinal Products (ATMPs) in Europe, are cell-based medicinal products aiming at replacing…
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blog
Tips to Select the Right Notified Body
In Europe, the review and approval of medicinal products involve Medicinal Competent Authorities from A to Z, the review and…
publication
Incorporating patients’ voices in the drug development process
Our Senior Director, Mike Day recently interviewed Robyn Bent, Director, CDER PFDD Program, Center for Drug Evaluation and Research, US…
blog
New FDA Guidance on Multiple Function Device Products & Its Impact on Software as A…
While the original Apple Watch was a genuine consumer product with fitness tracking and health-oriented capabilities, the adjunct of the…
webinar
How to create an aligned global co-development strategy for drug with device component combination products
Drug delivery technologies are becoming increasingly complex and integrated, combining various advanced technologies with the intent to deliver the drug…
presentation
How to overcome the regulatory challenges due to BREXIT
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th 2020. We shared our insights and thoughts…
publication
Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Policy
This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding…
publication
General Data Protection Regulation and Patients Enrolled in EU Clinical Trials
Processing and cross-border flows of personal data significantly increased over the past decades in the EU, and it became necessary…
blog
New Guidance on Clinical Evaluation of Medical Device Software
The Medical Device Coordination Group (MDCG) recently published a new guidance entitled “Guidance on Clinical Evaluation (MDR) / Performance Evaluation…
