European Pharmaceutical Review
JANUARY 25, 2024
These standardised documents provide meticulously curated and scientifically approved information. Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC.” Article 63 EMA (29 January 2020).
ISPE
FEBRUARY 13, 2023
While at TGA Bob also served as Deputy Chairman of PIC/S during 1998-1999, followed by a tenure as Chairman of PIC/S from 2000-2001. Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today.
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pharmaphorum
NOVEMBER 23, 2020
Through this outcomes measurement tool, patients keep comprehensive diaries of their condition, documenting what aspects of the disease affect them most. He joined Johnson & Johnson in 2001 as Director Corporate Communications. Let their voice be the driving force in our shared goal of making disease a thing of the past.
European Pharmaceutical Review
JULY 4, 2024
2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.
pharmaphorum
JANUARY 29, 2021
On top of this, there are the well-documented manufacturing challenges that come with such a new field. “I From 2001 to 2012, Dr Macrae held roles of increasing responsibility at GlaxoSmithKline, including senior vice president, Emerging Markets Research and Development (R&D). About the author.
pharmaphorum
SEPTEMBER 13, 2022
The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 2001– FDA green lights revolutionary treatments. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001.
Pharmaceutical Technology
FEBRUARY 24, 2023
But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs.
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