Latest Presentations
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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…
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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…
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Navigate the maze of MDR for Medical Device Software
This presentation is aimed at helping developers navigate the development and regulation maze of MDR for medical device software. Some…
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What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products?
What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A translational perspective Regulatory environment for…
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Regulatory And Development Strategies For Gene & Cell Therapies
The launch of a product is one of the most critical moments in its life-cycle. The product trajectory is firm…
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Smarter Orphan Drug Development
Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease…
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Impact on regulatory Framework for Clinical Trial Applications within the European Union
Impact on regulatory Framework for Clinical Trial Applications within the European Union from Voisin Consulting Life Sciences The current regulatory…
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Successful Commercialisation of ATMPs Starts at the Bench
Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing…
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