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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

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).

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Meet the company on a mission to transform research and advance healthcare

Pharmaceutical Technology

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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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.” This may lead to longer development timelines and higher costs for life science companies. This may also require investments in equipment and facilities.

Safety 63
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Japan’s M&A Boom

Pharmaceutical Technology

“In 2001, Japan’s Taisho Pharmaceutical tried to merge with Tanabe, but it failed due to differences in corporate culture.’ Like in many other sectors, China and India are the ones labelled as those which will lead the expansion. The sector is also attracting inbound activity from leading drugs companies.