New webinar
Patient access to Advanced Therapies in Europe 2009-2021: from early access failures to current challenges
The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its gene therapy products has put a new spotlight on the…
View webinar
Featured resources
blog
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)…
blog
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…
All our resources
More resources
webinar
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…
publication
IVDR Readiness Checklist
In the blog post “IVD Directive to IVD Regulation Transition – 8 months remaining”, my colleague outlined some key focus…
blog
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)…
blog
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…
blog
COVID-19 – THE LEARNINGS AND LONG-TERM IMPACT IN CLINICAL STUDY MANAGEMENT IN THE EU/UK
Introduction At the beginning of 2020, COVID-19 pandemic hit the whole world and led to unprecedented measures, including general lockdown…
webinar
Patient access to Advanced Therapies in Europe 2009-2021: from early access failures to current challenges
The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its…
publication
Possible Contexts of Use for In Silico trials methodologies: a consensus-based review
The term “In Silico Trial” indicates the use of computer modelling and simulation to evaluate the safety and efficacy of…
