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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Clinical Pharmacology & Therapeutics , 111(3), 531538. Freyr Solutions.

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Case Study 4 – Successful US/EU Marketing Applications for Big Pharma

Syner-G

As a result of repeat business, IMPACT (now part of Syner-G BioPharma Group) was contracted by a large, global pharmaceutical company to author the CSRs and accompanying submission documents to support a simultaneous US and EU submission for a combination respiratory product. and 2.7.2), and the Clinical Overview (Module 2.5).

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7. Reflections on a Career in Pharmacy and Medicine with Dr. Steven Berk

The Physician Pharmacist

I remember going to this gala affair put out by the pharmaceutical company in Chicago when this breakthrough new class of drug called ACE inhibitors, and Captopril was the first of the kind and, you know, that was that was a breakthrough, much less angiotensin blockers and all the new categories of antihypertensive so, so that was new.

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COVID-19 has propelled the regulatory industry years ahead

pharmaphorum

What remains very clear is that collaboration between sponsor companies, health authorities and other stakeholders will be required to move this forward. Regulators and pharmaceutical companies are investigating cloud-based platforms to enable the real-time sharing of data. Real-time sharing of data. Published 2021 Apr 9.

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Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

Increased collaboration and partnerships drive clinical research While R&D innovation is in part delivered by internal infrastructural components, it is also built by our outward-looking capabilities: principally, how we work with others to achieve our R&D goals. The COVID-19 blueprint has shown a way forward.

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Twenty Women Leaders In Healthcare Industry

PharmaShots

In 2016, she received a special career-recognition award from Fundamed Foundation (a non-profit Spanish foundation) in the category of the most influential pharmaceutical executive from Spain over the past 15 years Education: Belén is an alumnus of the University of Alcala de Henares as an MS, Ph.D.,

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

However, Amgen and other pharmaceutical companies have been criticised when they opted to choose the drug’s dosage based on the MTD model, which is commonly used in dose-finding trials. Impact on the industry Veal says that for a lot of pharmaceutical companies there is no “big drive to think about optimizing treatment” post-licensing.

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