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Ask the experts: Will you be ready for the new IVD regulation?
The major switch from IVD directive to IVD regulation is happening next year on the 26th May 2022. Notified Bodies (NB) and IVD legal manufacturers are getting ready for this…
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Non-traditional US Regulatory Programs for Drug and Medical Device Development
Introduction The Food and Drug Administration (FDA) offers several routine meeting types including Types A, B, B (End of Phase (EOP)), and C as outlined in Formal Meetings…
blog
Social Security Finance Bill 2021 in France: Reform on early access to health technologies What…
The PLFSS 2021 law was voted but all decrees are not yet published. Ongoing discussions with the CEPS (Pricing Committee)…
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IVD Directive to IVD Regulation (EU 2017/746) Transition – 8 Months Remaining
IVD Regulation Postponement Today 14th October 2021 the European Commission has issued a Question and Answers press release on the…
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webinar
Regulatory pathway and agency interaction: The EU vs the US
The introduction of a new medicinal product to the US and European market follows a complex process that may extend…
blog
Cell banks characterization expectation for microbiome therapeutical products
The last decade has marked the emergence of numerous microbiome treatments investigated in clinical trials. With a broad landscape, spanning…
publication
CMC considerations for US biosimilars development
The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provides an abbreviated licensure pathway for biosimilar products.…
webinar
Ask the Experts: EU CTR/CTIS: Adoption and Early Experience
The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now…
Case study
Solid Strategic Development Plans Eliminates the Blocking Points for Live Biotherapeutic Product
A French biotech had developed a live biotherapeutic product to target obesity and metabolic disease but were hindered by blocking…
webinar
Controversial and debated topics in Clinical Trials
A well thought out clinical strategy is critical for a clinical study, our experts of clinical study talk about the…
webinar
Interplay between ICH and Data Privacy – GDPR
As professionals in the life sciences industry, we work in a regulated environment and we are a key element in…
webinar
Ask the experts: EU regulatory framework for microbiome product development
Microbiome-based products, such as Live Biotherapeutic Products (LBPs) are very innovative, therefore associated with many challenges. Navigating the complex regulatory…
