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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
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…
blog
Advice on Non-clinical and Clinical Development for ATMPs from an Ex-CAT member
Gene Therapies and Cell-based products, referred to as Regenerative Medicine Advanced Therapy (RMAT) in the USA and as Advanced Therapy Medicinal…
publication
Clinical Trials with GMOs in the EU – From Regulatory to Sites
Clinical trials (CTs) with investigational medicinal products (IMPs) that contain or consist of genetically modified organism(s) (GMO-IMPs) have significantly increased…
Case study
Emergency Response: Getting Ahead of The Competitors
A US based emerging biopharma recognized that one of their anti-viral therapeutics being developed for a different indication might also…
webinar
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…
Case study
Taking the Pain out of Clinical Studies for Medical Devices
A French based research company were looking for guidance on developing a medical device to ensure MD safety validation. VCLS…
publication
Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs,…
The added value of in silico models (including quantitative systems pharmacology models) for drug development is now unanimously recognized. It…
blog
Expectations from Regulatory Agencies on Nitrosamine Impurities
On Friday, 27th March 2020, the European medicines regulatory network extended the deadline to complete an initial risk evaluation for…
