news
EMA approves biosimilar interchangeability in EU
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
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Regulation & Legislation
news
First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
article
Is localisation the answer for pharmaceutical supply chain resilience?
Highlighting the findings of a recent supply chain report, EPR’s Hannah Balfour discusses measures pharmaceutical suppliers may adopt to establish demand- and crisis-resistant supply chains. Commenting on the findings, Ernst & Young Global Limited colleagues Famke Krumbmüller, Derron Stark and Olaf Zweig elaborate on the impact and lessons learned through…
whitepaper
Whitepaper: Building a tomorrow-ready lab with CaliberLIMS
Achieve digital lab transformation by becoming future ready with the 100% paperless lab requisites. Check the wish list for a better tomorrow lab.
news
EU regulators release new workplan for accelerating clinical research
The latest workplan outlines how innovation in clinical research will be facilitated over the next four years, including modernising good clinical practice and issuing guidance on decentralised trials.
webinar
Pharmaceutical compliance audits: are you on top of regulations?
6 September 2022 | By MasterControl
Audits and inspections are always a stressful time for pharmaceutical companies. Watch this webinar to learn how to stay up to date on regulations and ensure audit readiness.
article
Pharmacovigilance deep dive: risk minimisation measures
Here IQVIA’s Dr Sophie Jouaville discusses the importance of risk minimisation measures, how their effectiveness can be assessed and why transparent reporting of these effectiveness studies is crucial.
whitepaper
Whitepaper: Annual PQR: A thing of the past
Anytime PQR is the new way of generating APQR by automating the reports anytime in 3 easy steps. Now make the entire process system driven with CaliberAPQR.
podcasts
EPR Podcast Episode 13 – QC spectroscopy compliance – Garry Wright and Julia Griffen, Agilent
Discover the common compliance concerns encountered when using spectroscopy instruments for QC, as well as how to rectify them in this episode with Agilent Technologies.
article
API nitrosamines: method sensitivity issues
Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.
article
Securing every dose with an edible security technology for safe medicines
The problem of counterfeit medicines is becoming a tremendous burden to society. An edible security tag affixed to each medicine can provide track and trace measures with dose information and on-dose (in-dose) authentication. Furthermore, it serves as a last line of defence against illicit pharmaceutical products. Young Kim, Associate Head…
news
Twice yearly HIV treatment approved in Europe
Gilead’s Sunlenca® (Lenacapavir) was authorised by the European Commission for people with multi-drug-resistant HIV who have very limited treatment choices.
article
The EU HTA regulation: a new frontier for access to innovative technologies
A new health technology regulation is due to be applied to help EU countries determine the effectiveness of novel technologies and decide on pricing and reimbursement by health insurers or health systems. Here, Professor Vincenzo Salvatore and Giuseppe Ragucci from BonelliErede reflect on what this means for the UK and…
article
European Pharmaceutical Review Issue 4 2022
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
news
Common pharma compliance concerns cited by FDA warning letters
A review of the last decade of FDA warning letters finds quality control operations, manufacturing process validation, and data record and integrity are the key points of scrutiny.
