Quality Systems

Cheryl Barton is director of PharmaVision, 

Articles

The European Commission has developed a roadmap aimed at reversing the rising trend of cancer across the European Union. 

Advancing the Precision Oncology Agenda in Europe

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Videos

Edwin Stone, Bernard Sagaert, and Khaled Yamout go behind the headlines to discuss what the ongoing measles outbreak in the UK means for pandemic preparedness and anti-vaccination trends; new mRNA approaches; and what Roche’s acquisition of Poseida means for complex cell therapies. 

Behind the Headlines: Pandemic Preparedness, Novel mRNA Applications, and More

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

EMA and HMA Publish Network Strategy for Public Consultation

Regulators, EMA and HMA, have published principles and recommendations 
on the use of LLMs, which are being increasingly used for daily tasks.


Responding to the Increased Use of Generative AI

Germany’s Medical Research Act allows pharmaceutical companies to keep drug prices confidential.

Germany Amends and Approves the New Medical Research Act

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

Using RWD in Non-Interventional Studies

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.

Improving Patient Access Through the UK IDAP Scheme

The European pharma industry needs to be prepared for the new clinical data requirements.

Looking at the Potential Impact of JCA on Pharma

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

Updating Swiss Regulatory Processes in 2024

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

European Regulatory Watch