European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Good documentation practices. What are three current key trends in data integrity?

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Putting Patients First Blog

APRIL 7, 2025

At the same time, as insights generated by AI increasingly shape the selection of drug targets, biomarkers, or dosing strategies that inform regulatory submissions, it is essential that any AI-derived outputs used to support regulatory decision-making meet appropriate standards of empirical validation and scientific transparency.

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Viseven

AUGUST 7, 2024

Medical writing refers to creating healthcare-related textual content that aims to improve doctor-patient communication and provide insights on industry topics. Medical writers must be outstanding communicators, capable of breaking down complex ideas for the public and healthcare professionals in a digestible way.

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pharmaphorum

DECEMBER 6, 2022

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. While many pieces of the drug development process have digitised to keep pace with the speed of technological advancements, clinical trials continue to lag amidst pharma’s digital transformation.

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Viseven

DECEMBER 13, 2024

Data collection involved paper forms, diaries, and in-person interviews , which, while essential for documenting symptoms and outcomes, were prone to human error. Maintaining regulatory compliance required extensive documentation and oversight, while handling paper-based data was labor-intensive and prone to mismanagement.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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Pharmaceutical Technology

JUNE 22, 2023

The European Commission’s (EC) plan to test a novel scheme to incentivise antimicrobial drug development companies remains beset by questions amidst the bloc’s drive to tackle the growing threat of antimicrobial resistance (AMR). However, additional initiatives that de-risk the development process are still needed, says Ruiz.

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Pharmaceutical Technology

APRIL 24, 2023

Artificial intelligence (AI) is set to be the most disruptive emerging technology in drug development in 2023, unlocking advanced analytics, enabling automation, and increasing speed across the clinical trial value chain. AI can then facilitate the analysis of data and develop all of the required tables, listings and figures (TLFs).

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Pharmaceutical Technology

NOVEMBER 28, 2022

To learn more about the development and partnership opportunities for businesses within Scotland’s health sector, download the document on this page. Precision Medicine: Streamlining Treatments and Drug Development. Free Whitepaper. Please check your email to download the Whitepaper.

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Putting Patients First Blog

APRIL 14, 2023

10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes. The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. He is reachable via e- mail at egascho@nhcouncil.org.

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Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. Clarity in communication is not just about convenience; it is a fundamental aspect of ethical medical practice and research.

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Viseven

DECEMBER 4, 2024

One of the most tragic was the thalidomide disaster, in which pregnant women prescribed the drug to treat morning sickness suffered severe birth defects. This made drug developers realize that flaws in the manufacturing process could go unnoticed. By the late 1970s, the concept of process validation was introduced.

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pharmaphorum

SEPTEMBER 6, 2021

Additionally, issues such as poor quality documentation due to template-based reporting, and incompatibilities between different systems have further caused headaches and increased inefficiencies. Many practitioners have expressed the feeling that EHRs cause far too much of their time ultimately being spent on data entry.

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pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. We talk a lot in clinical trials and drug development about benefit,” Dr Mullen said. But who is benefitting?

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pharmaphorum

OCTOBER 28, 2020

Data defines modern therapeutics, but this is almost uniquely confined to the clinical trial stages of drug development. PE isn’t traditional ‘communications’ where organisations talk to try and change patient behaviours, rather it’s about listening to patients to change corporate behaviours.

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FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. For drugs, the relevant CDER/CBER Division may or may not provide feedback; sponsors with specific questions may include them as a topic for discussion in meetings with FDA.

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Putting Patients First Blog

SEPTEMBER 26, 2024

Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. Health literacy: A three-part series to support better communication.

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Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). The price of progress: funding and financing Alzheimer’s disease drug development. Translational Medicine Communications, 4(18). autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L.,

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Pharmaceutical Technology

APRIL 27, 2023

LNPs are an adaptable, modular technology and when combined with microfluidic mixing, have the potential to accelerate development and commercialisation timelines and provide drug developers with an early foothold into a largely untapped market. Please check your email to download the Whitepaper.

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pharmaphorum

APRIL 8, 2021

Drug development alone is not really working to solve [chronic illness],” he added, noting that BIOS aims to use AI to read these neural signals, find out how they work and eventually control them to produce a therapeutic effect. In the UK we have world leading genetic sequencing capabilities.

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Viseven

SEPTEMBER 18, 2024

When COVID hit, the urgent need to accelerate drug development meant shrinking timelines from years to months, with no room for compromises on quality. Cloud computing facilitates effortless collaboration Cloud computing makes it easier for life sciences companies to communicate and collaborate globally.

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Express Pharma

OCTOBER 31, 2024

She highlighted that while the GCC was initially set up for cost savings in drug development, the focus has shifted to harnessing India’s vast talent pool, particularly in the scientific and medical fields, in an interview with Viveka Roychowdhury India seems to have become a hub for pharma GCCs. With a long gestation period.

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