pharmaphorum
JANUARY 18, 2022
Primary Packaging material designers. Secondary packagers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion. View the full agenda and speaker line-up online: www.pfsamericas.com/. Smart device developers.
European Pharmaceutical Review
JANUARY 25, 2024
These standardised documents provide meticulously curated and scientifically approved information. 2017) “Danmark har flest smartphones i hele verden”, Berlingske, Eurostat (2022) “Medicine Use Statistics” European Commission. 11 This requirement directly contradicts what is included in Article 63. Article 63 EMA (29 January 2020).
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ISPE
JANUARY 11, 2023
For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. Returning to a development process within the execution of a validation protocol can come with complexities in documentation and regulatory compliance. 11 (2017): 36–46.
The FDA Law Blog
SEPTEMBER 27, 2023
Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A.
Pharmaceutical Technology
MARCH 30, 2023
The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.
ISPE
MAY 11, 2023
The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Procedia CIRP 60 (2017): 86–91. to Industry 4.0
ISPE
MAY 9, 2023
Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.
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