RegRapPod − September 2023
Vol.20 #8: In the September 2023 episode of RegRapPod, podcast host Alan Booth hears from Issue Editor Vickie Goff about globalisation and the supply chain.
EMA suggests novel method to assess CKD therapies effectiveness
Glomerular filtration rate can be used as a surragate end point to assess clinical benefit in chronic kidney disease.
NICE recommends AI to aid radiotherapy treatment in England
First guidance from National Institute for Health and Care Excellence for use of artificial intelligence as tool for healthcare professionals.
NICE approves use of Rimegepant in NHS to treat acute migraine
Rimegepant is the first, and only, NICE-recommended treatment for acute migraine and is soon to be made available on the NHS in the UK.
EMA future ‘VetMeds’ for healthy animals and humans; seminar
In the lead up to the EMA’s Veterinary Awareness Day, Ivo Classen sits down to discuss the agency’s progress in the field of veterinary medicines.
Covid vaccines ‘not to be offered routinely’ to healthy under-65s
Only over-65s will get vaccination offered this year, the Joint Committee on Vaccination and Immunisation has advised UK government.
UK doubles capacity for certification of medical devices
TÜV SÜD, Intertek, and TÜV Rheinland UK have been designated as UK Approved Bodies to assess and certify general medical devices.
MHRA publishes ‘recognition route’ revised guidance
The MHRA has issued guidance on its International Recognition Procedure, which will replace the EC Decision Reliance Procedure from January 2024.
Semaglutide may help with PCOS, addiction disorders
Burkina Faso gives R21 malaria vaccine approval in children
Global life sciences consultancy created from SSI/NDA merger
Human COVID drug set to treat FCov-23 coronavirus in cats
Devices sold on second-hand market retain sensitive data
Rapid COVID-19 breath test device shows promise
Safe use of AI subject of EMA reflection paper
Semaglutide may help with PCOS, addiction disorders
Burkina Faso gives R21 malaria vaccine approval in children
Global life sciences consultancy created from SSI/NDA merger
Human COVID drug set to treat FCov-23 coronavirus in cats
Devices sold on second-hand market retain sensitive data
Rapid COVID-19 breath test device shows promise
September 2023 – Contents
The worldwide web of regulation
Q&A:
Navigating the
pharmaceutical supply chainNavigating the global supply of starting materials for cell-based therapies
Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry
Biosimilars CMC development considerations from the sponsor perspective
Warning letters for direct-to-consumer advertising: a five-year retrospective analysis
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Created with Quiz Maker
July/August 2023 – Contents
Equal access to medicines:
finding the balanceAfrican Medicines Agency and a new African regulatory ecosystem
EU versus Rest of the World regulatory frameworks and requirements for human tissue-based products
A year of clinical trials under IVDR:
a sponsor’s perspectiveThe impact of clinical data requirement
changes following EU Medical Device Regulation (2017/745) and Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)Regulatory challenges and opportunities facing hearing aid manufacturers in Europe
A critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – is there a difference and does it matter? Part 2
RegRapPod − July/August 2023
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European Parliament gives first stage approval for revised EMA fees
Change Across the Medical Device Landscape
Northern Ireland deal permits GB medicines but not medical devices
UK set to accept CE mark for medical devices until 2028
US Food and Drug Law Institute Annual Conference
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