Regulatory Excellence: Delivered

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Dr Lorraine Marsh

Posts made by this author are shown below.

Access Consortium

Access Consortium – Promise Pilot Pathway

Dr Lorraine Marsh
Dr Lorraine Marsh

Access Consortium Promise Pilot Pathway: what it is, what changed, and when to consider it When you are planning filings in more than one jurisdiction,...

NIMAR update May 2025

Dr Lorraine Marsh
Dr Lorraine Marsh

Recap In response to Brexit, on 1st January 2022, the UK brought in NIMAR (Northern Ireland MHRA Authorised Route) as a new supply route for...

ILAP Relaunched

Dr Lorraine Marsh
Dr Lorraine Marsh

I first wrote about the Innovative Licensing and Access Pathway (ILAP) back in 2021 (and again in 2023) so many of you will be familiar...

How the Windsor Framework will impact Pharmacovigilance

Dr Lorraine Marsh
Dr Lorraine Marsh

We have unpacked how the Windsor Framework (WF) affects Regulatory activities through several of our Fusion webinars and articles, so I thought it only fair...

Medicine shortage

Feeling the pain of a medicine shortage – views from a patient and pharma consultant

Dr Lorraine Marsh
Dr Lorraine Marsh

This is a joint article, written by two of Fusion Pharma’s Senior Regulatory Consultants. The first part is written by Dr Lorraine Marsh from a...

Vaping – views from a Regulatory Affairs expert… and mother

Dr Lorraine Marsh
Dr Lorraine Marsh

Has Australia got it right? By prohibiting all varieties of vaping devices, and making them only available on prescription, Australia appears to have gone much...

Fusion Footy

Dr Lorraine Marsh
Dr Lorraine Marsh

Did you know we sponsor an inclusive youth team on the South Coast?   The Berewood Panthers Pan-Abilities Football Teams (U11s and U16s) meet on...

Boosted development of children's medicines

Boosting development of children’s medicines

Dr Lorraine Marsh
Dr Lorraine Marsh

For as long as I can remember in my pharma career, there have always been challenges in enabling development of paediatric medicines. However, significant steps...

NIMAR – A Closer Look

Dr Lorraine Marsh
Dr Lorraine Marsh

NIMAR – A Closer Look Following on from my original blog titled ‘An Introduction to NIMAR‘, today we shall have a look in more detail,...

NIMAR vs Specials

An Introduction to the Northern Ireland MHRA Authorised Route (NIMAR)

Dr Lorraine Marsh
Dr Lorraine Marsh

An introduction to the Northern Ireland MHRA Authorised Route (NIMAR)   What is the background to NIMAR? Following Brexit the UK Government brought in a...