European Pharmaceutical Review
JANUARY 25, 2024
Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe. percent as EU average with some Member States as high as 25 percent).
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. Directive 2001/83 (as amended). References/Endnotes.
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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.
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.
Pharmaceutical Technology
OCTOBER 5, 2008
“In 2001, Japan’s Taisho Pharmaceutical tried to merge with Tanabe, but it failed due to differences in corporate culture.’ “Japanese companies did very few M&As, they were too independent to do more,” says Kaoru K Sato, managing director at PricewaterhouseCoopers (PwC).
Pharmaceutical Technology
FEBRUARY 20, 2023
On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. Hans Bunschoten: Viroclinics was founded in 2001, spun out of a university setting.
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