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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 with the right dose, at the right time and right…
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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…
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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Ask the Experts: How to have an effective INTERACT meeting with the FDA
INTERACT meeting is an informal non-binding consultation with the CBER at FDA. It allows sponsors to obtain preliminary informal consultation…
blog
The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014): where do we stand?
While the Regulation (EU) No 536/2014 was adopted back in 2014, its application in the European Union depends on the…
webinar
What are the reimbursement pathways for innovative digital health technologies?
Innovative digital health solutions are finding their ways into routine patient care in the US and Europe, and different payers…
publication
Driving the Healthcare Regulatory System Into the Future
This is a summary report on the panel discussion at the TOPRA Symposium 2020. The panel discussed how the EMA…
publication
TOPRA/RAPS Workshop on Alignment of Global Combination Products
The TOPRA/RAPS inter-regulatory and stakeholder two-day workshop held in June 2020 focused on global combination product regulations. The diverse panel…
webinar
Entering US market: FDA’s consideration on digital health technologies
VCLS is glad to organize this virtual event with the Innovation Center Denmark in Boston in collaboration with Welfare Tech…
blog
Summary of FDA Advisory Committee on COVID-19 Vaccines (Oct 22)
On Oct. 22nd, the Vaccines and Related Biological Products Advisory Committee from FDA held a nine-hour virtual meeting (Advisory Committee Meeting) to…
webinar
How to Secure Early Stage Development and First-In-Human Studies
We co-organized this digital event with Biopôle Lausanne. On this Webinar: Biopôle presentation (Olivier Philippe) …
