Dot Compliance

FEBRUARY 1, 2022

The global pharmaceutical industry has seen its share of challenges in recent years, from manufacturing and supply chain bottlenecks to growing demand for faster delivery of drugs to the marketplace. The post Future Trends and Regulatory Challenges in Pharma appeared first on Dot Compliance. Data in the regulatory spotlight.

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FDA COVID-19 Vaccine Pharmaceutical Industry COVID-19 52

HIT Consultant

AUGUST 18, 2021

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA. The pandemic has given rise to new norms in drug development that will influence the future of the industry as we know it. Food and Drug Administration (FDA), along with greater flexibility around mandates on alternatives to traditional clinical information.

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COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

Healthcare IT Today

JANUARY 8, 2024

It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. While each company successfully gained FDA approvals, the current market acceptance for prescription digital therapeutics is low and improvements will take years.

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SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies.

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FDA Compliance COVID-19 Public Health 52

HIT Consultant

NOVEMBER 17, 2021

Recent statements by the FDA and EMA support this emphasis, calling out the need for education and training of all constituents in a clinical trial to reduce unwanted protocol deviations and improve overall quality in clinical trial operations. Improving Protocol Compliance. About Robert Geckeler.

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COVID-19 Pharmaceutical Industry Informed Consent Compliance 97

SQA

AUGUST 2, 2021

This technical report focuses on the challenges facing the pharmaceutical industry that use complex packaging systems for sterile drugs and biologics (e.g., Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

APRIL 12, 2023

The ISPE APQ Guide: Cultural Excellence is the fifth and final guide in the series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. United States Food and Drug Administration (FDA) – Recalls Hospira, Inc. It is a valuable companion to this APQ Guide. and 225.165).

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FDA Compliance Pharmaceutical Industry 40

HIT Consultant

MAY 31, 2023

The pharmaceutical industry has experienced a wave of accelerated consolidation since 2010. In 2019, the industry saw a record-breaking 1,276 pharmaceutical M&A’s , representing a total value surpassing $411 billion. In 2017, only four companies were responsible for 50% of generic pharmaceutical drug production.

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SQA

JULY 8, 2022

88, Microbial Data Deviation Investigations in the Pharmaceutical Industry, January 2022. Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. PDA Technical Report No.

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Pharmaceutical Industry FDA Hospitals World Health 40

Hall Render

FEBRUARY 18, 2022

Meet new FDA chief Dr. Robert Califf: 5 things to know. Only 14% of Hospitals Met Price Transparency Rule Compliance. Outpatient push being felt in architecture industry. Bill on prescription drug pricing inspires support from Maine residents, opposition from pharmaceutical industry.

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