Quality Systems

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

Continuous improvements in technologies and services will help cold chain operators meet future industry demand.

Cold Comfort for Bio/Pharma

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

The UK’s National AI Strategy underpins the government’s long-term commitment and ambitions to enhancing the country’s digital ecosystem, with the health and life sciences sectors seen as pivotal contributors to meeting these aims.

An Overview of the UK’s National AI Strategy

EMA has recommended granting a marketing authorization in the EU for Kimmtrak (tebentafusp), a new medicine for a rare type of eye cancer.

EMA Recommends Granting Market Authorization in EU for New Medicine for Rare Type of Eye Cancer

EMA has recommended approval of Spikevax for children aged 6 to 11.

EMA Recommends Approval of Spikevax for Children Aged 6 to 11

Lloyd Smart, Head of Regulatory Affairs at 

MHRA has opened a consultation on the proposed changes to clinical trial legislation in the UK.

Consultation on Proposals for the Future of UK Clinical Trial Legislation

Guidance published during the pandemic has been updated to include content requirements for summary safety reports. 

EMA Updates Guidance on Risk Management Plans for COVID-19 Vaccines

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

EMA Investigating Reports of Menstrual Irregularities with COVID-19 Vaccines

The agency’s safety committee is reviewing the use of Janus kinase inhibitors to treat inflammatory disorders because of the potential for major cardiovascular problems.

EMA Reviews Safety of Janus Kinase Inhibitors to Treat Inflammatory Disorders

The agency recommended 53 new active substances in 2021, up 35% from 2020.

New Medicines Recommendations Up in 2021, EMA States

Stephan Hütter is associate director, Global Program Management at PharmaLex.

While companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.

Regulatory/GMP Compliance, Europe