Master MHRA Regulatory Affairs UK
Manage medical devices regulatory activities in the UK
Master MHRA Regulatory Affairs UK udemy course free download
Manage medical devices regulatory activities in the UK
Master medical devices registration in the most important and biggest market ever in the world, the market of UK, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.
The MHRA (Medicines and Healthcare Products Regulatory Agency) is the UK's regulatory body responsible for ensuring that medicines, medical devices, and blood components for transfusion meet applicable safety, efficacy, and quality standards. It operates under the Department of Health and Social Care (DHSC) and plays a key role in regulating pharmaceuticals post-Brexit.
What will you learn?
Product registration with MHRA
Master Regulatory Affairs processes of MHRA
The best regulatory pathway for the best product
Handling and matching MHRA regulatory pathways
Comparing the UK, to Britain, to Ireland regulations
Whis is the leader of the Great Britain region when it comes to regulations
What Ireland follows, and does not follow with MHRA
MHRA before and after Brexit
In this course we will be introduced to the details of MHRA regulations considering Brexit & UK Regulatory Framework
Since Brexit, the UK has followed its regulatory framework, separate from the European Medicines Agency (EMA).
Great Britain (England, Scotland, Wales) follows MHRA rules.
Northern Ireland still follows EMA regulations under the Northern Ireland Protocol.
We will master MHRA Regulatory Pathways
National Procedure (NP) – Full UK approval process for new medicines.
International Recognition Procedure (IRP) – Fast-track approval based on FDA, EMA, or other major agencies' decisions.
Innovative Licensing and Access Pathway (ILAP) – Accelerated pathway for innovative medicines (e.g., rare diseases, advanced therapies).
Rolling Review – Early engagement with MHRA for urgent treatments.
We will get introduced to MHRA Pharmacovigilance system: The Yellow Card Scheme
Yellow Card Scheme allows reporting of adverse drug reactions (ADRs), medical device failures, and counterfeit drugs.
Monitored by MHRA and the Commission on Human Medicines (CHM).
To have a global view of MHRA Collaboration & Global Role
Works with FDA (US), EMA (EU), WHO, and ICH for regulatory harmonization.
Active in Good Pharmacovigilance Practices (GVP) and International Coalition of Medicines Regulatory Authorities (ICMRA).
So, from a business point of view, you can place your product in the market quite faster and start earning your revenue quite fast also, moreover, the medical devices world is highly dynamic and innovative, compared to the pharmaceuticals, with lots of innovations and different versions of the same medical device could be played within the potential market of the UK.
Dear pharma industry future professionals, let us start our interesting journey toward medical device registration in the UK, we will travel together to the UK, meet the health authority there "MHRA", and explore its requirements for registration, renewal, and variations, let us place our products there.
In this course, we will cover all topics related to medical devices in the UK, starting from the requirements, interim regulations, classification, verification, and special conditions.
Then we will go deeper to see the actual forms, and templates as usual I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, and ensure its verification, of the medical, and interact with the actual MHRA gateway for the submission.
and we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, and 2DMatrix for all the shipments planned for UK market importation.
And finally, congratulations to you for mastering medical device registration in the UK market and see you soon in the pharma industry my dear colleagues.
Let's go
