European Pharmaceutical Review

MARCH 15, 2024

Incorporating the near-infrared spectroscopy (NIR) hyperspectral imaging (HIS) and ML technology at the production site itself would “automatically and rapidly ensure the traceability or quality control of the chemotype”, San Nicolás confirmed.

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Drug Topics

NOVEMBER 21, 2023

In counties with poor land quality, particularly urban counties, there was a higher incidence of early-stage disease and total breast cancer.

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European Pharmaceutical Review

MARCH 8, 2024

Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. Therefore, to achieve this, quality by design offers a systematic approach to development, the authors stated.

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STAT

APRIL 7, 2024

But about half of cancer drugs approved via this route fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-up , according to new findings presented Sunday at the American Association for Cancer Research annual meeting.

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FDA 143

Fierce Healthcare

APRIL 8, 2024

Patient experience monitoring company Press Ganey has taken its data integration partnership with Epic a step further, unveiling Monday an additional collaboration focused on nursing-related safety | Indicators and outcomes logged in the EHR platform will be pulled into Press Ganey's National Database of Nursing Quality Indicators, which is used (..)

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Fierce Healthcare

DECEMBER 5, 2023

Nearly 60% of doctors who practice as employees of hospitals and other corporate entities say that non-physician practice ownership results in lower quality patient care, per a new survey. | Most docs surveyed cited decreased time with patients and greater focus on financial success as elements negatively affecting quality at non-physician-owned medical (..)

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Patient Care Hospitals 118

Pharmaceutical Technology

DECEMBER 11, 2023

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

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pharmaphorum

NOVEMBER 27, 2023

Cultivating quality excellence in the clinical trials landscape Mike.Hammerton Mon, 27/11/2023 - 09:23 Bookmark this

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The FDA Law Blog

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality.

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FDA Immunization 59

European Pharmaceutical Review

NOVEMBER 16, 2022

Across all of this is the criticality of compliance with Good Manufacturing and Good Distribution Practice (GMP/GDP) and of a fit-for-purpose quality system. Making quality more integral to production. So what might that look like? Embracing the spirit rather than the letter of regulations. Process (and portfolio) optimisation.

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Documentation Vaccines 116

Fierce Healthcare

JULY 5, 2023

The quality bonus program (QBP) that rewards Medicare Advantage (MA) plans fails to achieve its two main goals: fairly rewarding MA insurers that actually improve quality and encouraging beneficiar | The Medicare Advantage Quality Bonus Program suffers from what some experts call the “Lake Wobegon Effect”: Too many plans are rated above average.

Insurance 110

Insurance 110

Fierce Healthcare

OCTOBER 9, 2023

Boulder Care, a telehealth provider for substance use disorder, has met all of its performance quality measures in a value-based payment arrangement with a managed Medicaid insurer in Oregon. | Boulder agreed to put a portion of its reimbursement for medical services at risk until quality performance metrics were achieved.

Insurance 121

Insurance 121

ISPE

DECEMBER 13, 2022

Advancing Pharmaceutical Quality Cultural Excellence. Advancing Pharmaceutical Quality Cultural Excellence. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Associate Director Corporate Quality Systems. Trudy Patterson.

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STAT

NOVEMBER 16, 2023

Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems.

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FDA 130

Fierce Pharma

JANUARY 22, 2024

The observations run the gamut from problems in tracking manufacturing processes and quality controls to equipment calibration lapses and poor facility maintenance. . | Following a July inspection, the FDA has uncovered eight new production deficiencies at Eli Lilly's Branchburg production plant.

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FDA 126

STAT

JANUARY 17, 2024

Researchers from the University of California San Diego School of Medicine say a new method can better predict the quality of embryos used for in vitro fertilization, potentially raising the odds of a successful pregnancy for those relying on assisted reproductive technology. 

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ISPE

SEPTEMBER 15, 2023

These technologies are not just trends; they are pivotal tools that enhance manufacturing processes, proactively address quality concerns, and expedite the development of life-saving drugs. The Regulatory, Compliance, and Quality sessions, promise to be a comprehensive exploration of the vital topics shaping the pharmaceutical landscape.

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FDA Pharmaceutical Companies Pharmaceutical Companies Patient Care 98

European Pharmaceutical Review

MARCH 1, 2024

The post 2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends appeared first on European Pharmaceutical Review. Although pharma companies are working steadily to leverage the power of data and become more agile and resilient, there is still room for improvement.

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European Pharmaceutical Review

JULY 24, 2023

Proficiency testing programmes aim to increase the product analysis and knowledge to contribute to overall improvement in drug product quality. A paper published in Pharmaceutics has proposed how a personalised preparation quality assurance programme can achieve this when these products are developed in compounding laboratories.

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Compounding Documentation 73

Fierce Healthcare

AUGUST 16, 2023

National Quality Forum is joining the Joint Commission in a merger deal that the groups say will allow both to refine quality and outcome measures they develop for the industry. |

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European Pharmaceutical Review

MAY 17, 2023

A market report has shown that to improve efficiency, quality and to reduce costs in drug manufacturing , Pharma has been adopting automated quality management systems, digitalisation of processes and integration of data analytics. What is limiting growth of the pharmaceutical quality management systems market?

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Pharmaceutical Companies Pharmaceutical Companies FDA 88

PQA

DECEMBER 20, 2023

This guest blog is one in a series by sponsors of the 2023 PQA Leadership Summit on elevating clinical quality assurance. At MedWatchers, quality is at the top of our priorities. Delivering the highest quality of clinical services is paramount in ensuring healthcare resources don’t go to waste.

Patient Care 81

Patient Care 81

Drug Topics

NOVEMBER 8, 2022

Follow-ups from pharmacists show a significant increase in outpatient antiemetic drugs prescribed and quality of life in patients experiencing chemotherapy-induced nausea and vomiting.

Chemotherapy 144

Chemotherapy 144

PQA

DECEMBER 5, 2023

Diverse Voices in Quality is a PQA blog series that showcases the successful career paths and experiences of medication use quality professionals from diverse groups at PQA member organizations. He serves on PQA’s Health Equity Technical Expert Panel and is a member of the 2023 PQA Quality Metrics Expert Panel.

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Insurance 59

Pharmacy Times

JULY 21, 2023

For adolescents and young adults affected by HIV, Google yielded higher quality information on pre-exposure prophylaxis more frequently compared to other search engines.

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Pharmacy Times

AUGUST 9, 2023

With the continued advancement and approval of cell and gene therapies, the need for trustworthy microbiology quality control solutions is at an all-time high.

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PharmExec

NOVEMBER 8, 2022

Why enabling a shared culture of quality across an organization is key to maintaining pharma’s recent pace of innovation wins—while inspiring new levels of confidence.

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BioPharm

APRIL 17, 2024

At INTERPHEX 2024, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, explores the impact of QMS on quality maturity.

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pharmaphorum

OCTOBER 20, 2023

How quality of life can drive equitable cancer care and outcomes Mike.Hammerton Fri, 20/10/2023 - 08:00 Bookmark this

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European Pharmaceutical Review

NOVEMBER 23, 2022

The European Medicines Agency (EMA) has established the Quality Innovation Expert Group (QIG) to aid innovative approaches for the development, manufacture and quality control (QC) of medicines, including new technologies, digitalisation, novel materials and novel devices for patients in the European Union (EU).

Documentation 105

Documentation 105

Fierce Healthcare

AUGUST 31, 2023

Employers fund huge swaths of the healthcare system, yet the quality of care their employees receive varies widely. Employers fund huge swaths of the healthcare system, and yet the quality of care their employees receive varies widely, a new study shows.

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European Pharmaceutical Review

JULY 4, 2023

However, critical disciplines within the field responsible for ensuring safe and effective drug products, including quality assurance and compliance, remain mysterious or invisible to many. Quality assurance and compliance-related plans are affected by supply chain issues.

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Communication Dosage Chemotherapy Documentation 87

PQA

JULY 10, 2023

Health information technology and public policy are two topics in health care that are continually evolving, as is their impact on medication use quality. Various functionalities in healthcare utilize interoperability to enhance patient experiences by promoting safety, quality, and value-based care.

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Pharmacy Times

FEBRUARY 12, 2024

Foud Atouf, senior vice president of global biologics at US Pharmacopeia, discusses the importance of robust quality standards in addressing concerns regarding biosimilar safety and efficacy.

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PQA

FEBRUARY 29, 2024

Ensuring the quality of medication use is critically important for rare disease patients, payers, clinicians, specialty pharmacies and everyone with a role in the care process. PQA is the national quality organization dedicated to improving medication safety, adherence, appropriate use and medication management services.

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Specialty Pharmacies Communication Patient Care 45

Pharmacy Times

JULY 21, 2023

Multiple myeloma clinical pathways and factors affecting patient quality of life are explored by an expert panel.

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PQA

FEBRUARY 20, 2024

Patients, caregivers, family members and advocates have a critical role to play in high-quality medication use. Importantly, our commitment is aligned with the CMS National Quality Strategy and the person-centered care principles that are part of CMS’ Meaningful Measures 2.0.

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