JAMA Internal Medicine

APRIL 25, 2021

This quality improvement study assesses hand hygiene compliance rates in a hospital with an automated hand hygiene monitoring system during the COVID-19 pandemic.

Compliance 91

Compliance 91

Cloudbyz

JUNE 16, 2023

Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Purpose of Clinical Trial Data Archiving: Compliance: Regulatory authorities require clinical trial data to be retained for a specific duration to demonstrate compliance with guidelines and regulations.

Clinical Trials 94

Clinical Trials Clinical Trials Compliance Trials 94

Pharmaceutical Technology

DECEMBER 15, 2022

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

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Medicine Manufacturing Pharma Companies Production 246

Worldwide Clinical Trials

JANUARY 6, 2025

Technological advancements have fostered novel drugs and improved precision medicine, suggesting an increased trend of R&D in this direction. To meet the specific requirements of each study, we apply appropriate regulatory standards, including CLIA compliance, full validation, or fit-for-purpose quality.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Cloudbyz

APRIL 25, 2023

This comprehensive guide delves into the essentials of pharmacovigilance regulatory reporting, highlighting its significance in maintaining drug and device safety, and ensuring compliance with regulatory requirements. Different types of reports have specific timelines for submission, and delays may result in regulatory actions or penalties.

Compliance 97

Compliance Clinical Trials Clinical Trials Manufacturing 97

pharmaphorum

JULY 21, 2022

With attention and resources focused elsewhere during the pandemic, it’s likely that many facilities may have slipped into a state of non-compliance, which may result in unsuccessful inspections. Doing so means that businesses can check their compliance before an FDA inspection. She has a Ph.D.

Compliance 98

Compliance Regulation Manufacturing Contamination 98

Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Staying informed of regulatory changes is crucial for businesses to ensure continued compliance and avoid disruptions in their operations.

Medicine 130

Medicine Production Packaging Packaging 130

Pharma in Brief

APRIL 25, 2021

These amendments permit patents claiming different forms of a medicinal ingredient (e.g., different salt forms) of the medicinal ingredient in comparison to the Canadian Reference Product (“ CRP ”). ii) a claim for the base form of the medicinal ingredient (where the approved medicinal ingredient is a salt form).

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Regulation Medicine Generic Drugs Containment 98

Drug Patent Watch

DECEMBER 10, 2024

Enhanced Regulatory Compliance : Integrated CDMOs can provide comprehensive supervision over all research, development, and manufacturing initiatives, ensuring compliance with strict regulatory guidelines set by entities like the FDA and EMA.

Manufacturing 94

Manufacturing Development Drugs Compliance 94

Drug Patent Watch

AUGUST 28, 2024

The European Union (EU) has implemented a robust regulatory framework to ensure the quality and safety of active pharmaceutical ingredients (APIs) used in medicines.

Compliance 59

Compliance Manufacturing Medicine Marketing 59

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

Regulation 52

Regulation Compliance Medicine Manufacturing 52

Pharmaceutical Technology

JUNE 29, 2022

The next wave of medicine is well on course to be cell and gene-based. In September 2021, GlobalData figures revealed there to be 1,320 industry-sponsored regenerative medicine and advanced therapy trials ongoing worldwide. Meanwhile, the pharma industry is undergoing somewhat of a transformation itself.

Drugs 295

Drugs Gene Therapy Production Manufacturing 295

Rethinking Clinical Trials

DECEMBER 18, 2024

The fidelity to the NCM intervention, measured by the participation in 20 NCM calls and the compliance with HBPTM, was around 68% – a decent figure given the challenges of conducting a trial in a real-world setting, Dr. Ogedegbe noted. with Black and Hispanic populations experiencing poorer outcomes than Caucasian populations.

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Nurses Clinical Trials Clinical Trials Trials 100

FDA Law Blog

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture. next week, on December 6-7, 2023.

Compliance 59

Compliance Life Science Marketing Medicine 59

Cloudbyz

AUGUST 13, 2024

In the realm of clinical trials, regulatory compliance is a cornerstone that ensures the integrity, reliability, and safety of collected data. For EDC systems, compliance is particularly critical because these systems manage vast amounts of sensitive data electronically.

Compliance 52

Compliance Clinical Trials Clinical Trials Regulation 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Worldwide sourcing and drop-ship of orphan medicines, and. GDP and GMP advisory. Temperature control facilities and supply solutions.

Packaging 130

Packaging Packaging Compliance Manufacturing 130

BioPharma Reporter

MARCH 3, 2022

WuXi STA says its drug product facility in Wuxi City, China has successfully passed its first pre-approval inspection (PAI) and received the GMP compliance certificate from the European Medicines Agency (EMA).

Production 97

Production Compliance Drugs Medicine 97

Pharmaceutical Technology

JUNE 5, 2023

Right now, it’s compliance by checkbox, in a static way. Pharmacies have also received EU General Data Protection Regulation (GDPR) fines for not being in compliance,” he adds. Genomic data plays a central role in the future of the field, especially as new cell therapies and more personalised medicine comes of age.

Genome 276

Genome Genomics Regulation Compliance 276

The Pharma Data

MARCH 9, 2021

Eli Lilly and Company (NYSE: LLY) today announced the upcoming retirement of two executive committee members and the naming of their successors in the company’s manufacturing operations and ethics and compliance organizations. Hernandez and Weems will report to David A.

Compliance 52

Compliance Manufacturing Engineer Medicine 52

Pharmaceutical Technology

JANUARY 20, 2023

And delays in the supply chain, even for short periods of time can potentially affect the efficacy of medicines, lead to longer-term supply bottlenecks, and ultimately prevent people from getting access to the critical medicines they need.

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Manufacturing Clinical Trials Clinical Trials Production 356

The Pharma Data

MAY 12, 2021

Industry would like to see some “pragmatic” changes to the regulatory process for pediatric medicines in the EU, according to a recent presentation at RAPS Euro Convergence 2021. . Posted 12 May 2021 | By Jeff Craven . When the Pediatric Regulation (EC No. Here, “the submission of PIPs is a binary item,” he said.

Medicine 52

Medicine Compliance Regulation Clinical Trials 52

Advarra

MARCH 7, 2025

Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. With more than three decades of experience, Advarra is dedicated to advancing clinical research by providing expert oversight.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JUNE 2, 2023

Under the notice of compliance with conditions (NOC/c) policy, AB Science received authorisation from Health Canada to file a new drug submission for masitinib to treat ALS. The US Food and Drug Administration and the European Medicines Agency granted orphan drug designation to masitinib.

Compliance 130

Compliance Licensing Licensing Drugs 130

STAT News

FEBRUARY 27, 2023

In arguing its case, the Universities Allied for Essential Medicines maintained the FDA has done such a poor job of enforcing the law that a lack of compliance “remains widespread” and potentially life-saving data have been kept from the public.

Trials 98

Trials Clinical Trials Clinical Trials Compliance 98

pharmaphorum

JUNE 1, 2021

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. Specific apps could also alert healthcare providers if vulnerable patients are failing to scan their medicine. This technology can also play an important role in supporting virtual clinical trials.

Medicine 52

Medicine DNA Pharmacy Production 52

Camargo

NOVEMBER 11, 2020

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. Manager of Regulatory Compliance. Ken Phelps.

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Development Bioequivalency Generic Drugs Production 242

Drug Channels

SEPTEMBER 18, 2023

Showcasing high level discussions on access strategy, patient interactions, case management, compliance practices and more, this two-and-a-half-day event helps navigate complex compliance hurdles to advance and enhance your patient-oriented programs. Tom Hiney, Privacy Counsel , Blueprint Medicines Matt Howatt, Assistant U.S.

Compliance 75

Compliance Drugs Medicine Marketing 75

Pharmaceutical Technology

DECEMBER 5, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also since granted the Great Britain marketing authorisation of Lupkynis to treat adults with active LN. However, the lack of in-person administration by physicians will likely also impact patient compliance.

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FDA Approval Compliance Trials Marketing 147

Cloudbyz

NOVEMBER 1, 2023

Regulatory Compliance: Numerous regulatory authorities worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), mandate the use of MedDRA for reporting adverse events and conducting pharmacovigilance activities. It offers 360 degree view across R&D and commercial.

Compliance 109

Compliance Drugs Production Regulation 109

Drug Patent Watch

DECEMBER 10, 2024

Regulatory Compliance : Scientific experts must ensure that generic drug development adheres to strict regulatory guidelines. This involves understanding the legal and ethical standards set by regulatory agencies such as the FDA and the European Medicines Agency (EMA). ” References : BioPharma Services.

Generic Drugs 98

Generic Drugs Bioequivalency Development Drugs 98

pharmaphorum

MAY 10, 2021

According to the Observer, professor Martin Hibberd , of the London School of Hygiene and Tropical Medicine said that proposals to allow limited international travel without need for quarantine from later this month could lead to more variants entering the country.

Vaccination 124

Vaccination Vaccine Compliance Medicine 124

Pharmaceutical Technology

MAY 23, 2023

In April, the pilot-level Nordic Pharmaceutical Forum (NPF) initiative, representing Finland, Iceland, Norway, Sweden, and Denmark, released an updated strategy document outlining the region’s plans to establish a joint procurement mechanism for medicines, with a declared focus on advanced therapy medicinal products (ATMPs) such as gene therapies.

Medicine 130

Medicine Gene Therapy Marketing Gene 130

Worldwide Clinical Trials

MAY 1, 2024

This support includes taking advantage of valuable guidance and direction from regulators, primarily in scientific advice, to support study design that generates robust information on how well a medicine works and how safe it is. An illustrative example of harmonization between agencies exists via the European Medicines Agency (EMA) and U.S.

Clinical Research 173

Clinical Research Trials Research Clinical Trials 173

Pharmaceutical Technology

SEPTEMBER 15, 2022

Increasing medicine sales through e-pharmacies and the growing adoption of advanced packaging solutions are projected to drive the demand for contract commercial packaging in the pharmaceutical sector. Finding the best commercial packaging suppliers in contract marketing. Trends in pharmaceutical contract packaging.

Packaging 100

Packaging Packaging Marketing Containment 100

pharmaphorum

MARCH 14, 2022

This morning, Sandoz announced it has acquired medical and drug delivery device specialist Coalesce Product Development, bolstering its capabilities for the development of respiratory medicines and ‘complex’ generics.

Sales 104

Sales Drug Delivery Marketing Production 104

Pharma Tutor

SEPTEMBER 24, 2020

Pharmacists are transforming global health by empowering patients and other health care providers through counselling, drug information and motivation for rational use of medicines. Pharmacists strive to eliminate medication errors and ensure strict patient compliance to achieve desired therapeutic outcomes.

Compliance 56

Compliance Medicine Drugs 56

VirTrial

AUGUST 21, 2021

Finally, any mention of HIPAA is usually in the context of “compliance” through a Business Associate Agreement (BAA), and supporting documentation is usually rife with ambiguities. Other important characteristics that make these solutions ideal for clinical research include: HIPAA, HITRUST, and/or SOC 2 certification (not just “compliance”).

Clinical Research 97

Clinical Research Research Clinical Trials Clinical Trials 97