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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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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 are glad to co-organize this digital event with Biopôle Lausanne. Biopôle Lausanne is an innovation-oriented life sciences campus hosting…
blog
What are the Need-to-Know incentives associated with an Orphan Drug Designation (ODD)?
With a low prevalence, rare diseases affect six to eight percent of the population worldwide and therefore represent a global…
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…
