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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) is key for successful product development – at the time…
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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…
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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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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…
Case study
Innovative Marketing Authorization Transfer Preserves Vital Patient Supply
The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment…
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How can you take advantage of China’s accelerated regulatory pathways for your product development?
Global drug innovation in the East has significantly increased in recent years. China is one of the major players and…
Case study
How To Expedite Clinical Development Via Early Access Programs
If you are developing a drug for a rare disease in the European Union, you may qualify for an Early…
webinar
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)…
blog
The EU Regulatory Framework for Microbiota Transplants: An Industry Perspective
The current European regulatory framework for Blood Tissue and Cells is being replaced by a new Regulation, which includes a…
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Key Points in the CTR Transition of Clinical Trials
Are you an innovator with a product undergoing clinical trial? This article covers all you need to know about the…
Case study
A Proactive and Reactive Team in Orphan Drug Development
Are you in need of a proactive and reactive team in orphan drug development? An orphan drug is a designation…
