European Pharmaceutical Review
AUGUST 11, 2023
Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. However, the STAND results did not suggest new safety concerns with crizanlizumab. EMA required the STAND study as part of the marketing authorisation.
European Pharmaceutical Review
JULY 25, 2022
The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.
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European Pharmaceutical Review
OCTOBER 27, 2023
Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.
European Pharmaceutical Review
DECEMBER 19, 2022
3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. Chris was named a ‘Rising Star’ in the 2022 Legal 500 Rankings for Life Sciences and Healthcare. References/Endnotes. Biosimilars in the EU.
Pharmaceutical Technology
FEBRUARY 24, 2023
The products that are authorised in EU are largely the same as other regions,” argued European Commission Directorate-General for Health and Food Safety Florian Schmidt, during the same online event. But others do not accept that the EU is less competitive for the pharma industry than North America and Asia. You can compare timelines.
pharmaphorum
AUGUST 4, 2022
AR has developed enormously over the last few years, meaning that highly visual step-by-step guidance and training procedures can be delivered to employees to ensure they follow safety protocols without being exposed to actual real-life risks in the manufacturing facility. Raising the profile. She joined NSF in 2017. appeared first on.
European Pharmaceutical Review
JULY 20, 2023
Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.” This will enable better monitoring of the safety and quality of these products, but it may also require additional investments in IT infrastructure.
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