Compliance Contamination Development Regulation 
Advarra
SEPTEMBER 14, 2023
In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.
World of DTC Marketing
FEBRUARY 28, 2021
SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. So should we forget all that because they developed a COVID vaccine? The answer is NO.
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The Pharma Data
NOVEMBER 18, 2020
The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).
The Pharma Data
MAY 3, 2021
Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . .
pharmaphorum
JUNE 8, 2022
Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0
FDA Law Blog
DECEMBER 13, 2021
Subpart E of the PSR was specifically developed to address agricultural water quality control. The regulated industry criticized the complexity and the one-size-fits-all approach of Subpart E. In 2017, in an effort to lighten the burden for affected parties, FDA proposed to extend compliance dates until at least Jan.
The Pharma Data
OCTOBER 30, 2020
The fifth meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (IHR) (2005) regarding the coronavirus disease (COVID-19) took place on Thursday, 29 October 2020 from 12:30 to 16:05 Geneva time (CEST). Proceedings of the meeting. Diagnostics, therapeutics, and vaccines 10.
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