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![Post thumbnail Demystifying the US IND process for initiation of clinical trials](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/02/画一张比例为16:9,包含美国,美国FDA,临床试验元素的图,简洁一些,不要包含太多元素_0-233x260.webp)
Demystifying the US IND process for initiation of clinical trials
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a…
![Post thumbnail Getting an Early Access Program Off the Ground Safely](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2023/12/shutterstock_317573702-1-233x260.jpg)
Getting an Early Access Program Off the Ground Safely
Embracing an Early Access Program (EAP) presents a strategic avenue for creating valuable opportunities for patients and companies. This webinar…
![Post thumbnail Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in the US and EU](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2023/10/shutterstock_2149237967-e1697090677318-233x260.jpg)
Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in…
Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space…
![Post thumbnail Ask the Experts: How to use microbiome as an innovative diagnostic tool](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2023/07/shutterstock_2034928148-233x260.jpg)
Ask the Experts: How to use microbiome as an innovative diagnostic tool
Over the past decade, innovations in both sequencing technology and computational biology have led to a growing interest in profiling…
![Post thumbnail Key CMC and NC considerations for cell and gene therapy development](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2023/07/MicrosoftTeams-image-e1688372304955-233x260.png)
Key CMC and NC considerations for cell and gene therapy development
ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US,…
![Post thumbnail Ask the Experts: EU-CTR – How to tackle the Requests for Information (RFIs) Challenge?](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2022/04/Picture1-233x260.png)
Ask the Experts: EU-CTR – How to tackle the Requests for Information (RFIs) Challenge?
The EU CTR (Clinical Trials Regulation) no. 536/2014 became effective on 31 January 2022. Among all the challenges, Sponsors often…
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Ask the Experts: MHRA’s Innovative Licensing and Access Pathway (ILAP)
In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming…
![Voisin Consulting Life Sciences default webinar thumbnail](https://r5fb28.n3cdn1.secureserver.net/wp-content/themes/understrap-child/img/voisin_consulting_life_sciences_default_thumbnail_webinar.png)
Ask the Experts: QPPV – What is it?
Before submitting your marketing application in Europe or the UK, thinking about the PharmacoVigilance System and its Qualified Person (QPPV)…