The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). the current default version internationally, was established in 2008. Implementation Package v1.5 Implementation Package v1.5

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Packaging FDA International Pharmaceuticals 52

Agency IQ

NOVEMBER 27, 2023

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

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FDA Science Drugs Regulations 40

Perficient: Drug Development

OCTOBER 4, 2023

CLIENT An American multinational corporation that develops medical devices, pharmaceuticals, and consumer packaged goods. PROJECT BACKGROUND Since 2008, Perficient has delivered multiple infrastructure platforming, commerce, and management consulting projects for this multinational corporation.

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Clinical Trials Trials Packaging Science 52

Agency IQ

JUNE 21, 2024

Regulation (EC) No 1234/2008 (Variations Regulation) provides the procedures for implementing the different types of variations. That same year, the Pharmaceutical Strategy for Europe called for a revision of the Variations Regulation and an evaluation of the existing legislation. could benefit both industry and regulators.

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Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. When Louis Miller, now Chief of Malaria Cell Biology at the NIH, attended a malaria conference in Shanghai in 2008, he asked: Who discovered artemisinin? Nobody had an answer.

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Drugs Science Research Doctors 132

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. Circuit granted EPA a voluntary remand in 2008 for the Agency to re-evaluate the MACT floors established in 1995 based on the D.C. EPA, 358 F.3d 3d 936 (D.C.

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Agency IQ

JUNE 16, 2023

Section 2008 Improved Consumer Confidence Reports amended the Safe Drinking Water Act section 1414(c)(4) to revise requirements for Consumer Confidence Reports (CCR). EPA recently reclassified several areas as Severe nonattainment areas for the 2008 ozone NAAQS. These areas include Dallas-Fort Worth, TX, Denver-Boulder-Greeley-Ft.

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