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Regulation & Legislation
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
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…
Achieve digital lab transformation by becoming future ready with the 100% paperless lab requisites. Check the wish list for a better tomorrow lab.
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.
6 September 2022 | By MasterControl
Audits and inspections are always a stressful time for pharmaceutical companies. Join us to learn how to stay up to date on regulations and ensure audit readiness.
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.
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.
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…
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…