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Where science and technology are evolving quickly, a good networking structure is needed to keep pace of advancements. This is especially relevant for regulatory agencies in the pharmaceutical field. EMA recognizes this and addresses it with the strategic plan: Regulatory Science to 2025 – focused on quality, safety and efficacy of both human and veterinary medicines. The draft of this plan, which was created by the Member States and the European Commission, and comprised input from two workshops with stakeholders, was published in December 2018 for a six-month public consultation.
Regulatory Science to 2025 has five goals:
These goals contain core recommendations and actions that address specific topics such as precision medicine, biomarkers, advanced therapy medicinal products, novel manufacturing, and nanotechnology, and also futuristic topics such as artificial intelligence, 3D printing and big data.
West is vigilant of the ever-changing regulatory landscape in order to support customers with the information, products, and services needed in order to comply. For more information, contact and Account Manager or Technical Customer Support (TCS) representative, or visit the West Knowledge Center.
Today’s business environment demands a seamless and continual transition of digital experience to conduct business and engage various stakeholders in the same way we conduct the rest of our lives outside work. The experience expectation is consistent across devices of choice from phones to tablets to laptops. That’s why West partners with the world’s top pharmaceutical, biotech, device and diagnostic companies to embrace technology that supports the patients they serve with online resources and tools to better manage their health. In turn, we’re looking to support our customers with digital tools to help speed the research and development process of bringing life-saving medicines to patients that need them.
Since the Technical Guideline on Compatibility Study of Chemicals and Elastomeric Closures was published by the National Medical Products Administration (NMPA, previously known as CFDA) in April 2018, it is essential for pharmaceutical companies to perform compatibility studies. However, for some domestic pharmaceutical companies that lack experience, it is unclear how to perform such a study. To address this, a series of trainings was planned by China National Pharmaceutical Packaging Association (CNPPA) – with the first held in December 2018. There were over 100 attendees from pharmaceutical companies, pharmaceutical packaging companies, NMPA-affiliated labs, and the third-party labs. The training received positive feedback from the participants.
<p style="margin: 0in 0in 10pt;"><span>In <a href="/zh-cn/blog/2017/may/part-1-packaging-supplier-reg-sup-for-med-products">Part 1</a> of this series, we discussed the primary questions to consider when evaluating potential regulatory support from a packaging component supplier. Beginning with this post, we’ll start to look into each of these questions in more detail.</span></p>
The Standing Committee of the National People’s Congress in China passed the revised Drug Administration Law (Revised Law) on 26-Aug-19. Effective 1-Dec-19, it is the first overhaul since 2001.The Revised Law addresses the major issues in the pharmaceutical industry, demonstrating the government’s efforts in strengthening supervision to ensure drug safety.
We recently announced our partnership with <a rel="noopener noreferrer" href="https://techin-iitpkd.org/" target="_blank">TECHIN – a Technology Innovation Foundation of IIT Palakkad</a> which focuses on assisting innovation and incubation for growing entrepreneurs, to build a Medtech Research Center of Excellence.
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