STAT

FEBRUARY 23, 2023

Health tech companies are in a tizzy: After years of letting companies roll out software tools to guide patient care with little oversight, the Food and Drug Administration is taking a tougher stance. But the industry says it was blindsided by the move.

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BioPharma Dive

JANUARY 12, 2024

Showing reporters and industry veterans a demonstration of its new drug development software, Recursion said at J.P. Morgan it is now licensing its work to buyers.

Drug Development 62

Drug Development 62

FDA Law Blog: Biosimilars

MAY 6, 2024

FDA interprets the “software” definition to include software that is firmware or programmable logic in addition to software in a medical device (SiMD) or software as a medical device (SaMD). Doing so may be inconsistent with the least burdensome requirement as well as the concept of substantial equivalence.

Documentation 105

Documentation 105

Express Pharma

APRIL 4, 2024

The companies will join forces to advance the use of precision medicine on a global scale SOPHiA GENETICS, a cloud-native software company in the healthcare space has announced a strategic partnership with Strand Life Sciences to deliver innovative solutions that will fuel the use of precision medicine globally. Jurgi Camblong, PhD.,

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Express Pharma

MAY 16, 2023

Eminence Business Media recently announced the third Annual Computer Software Assurance 2023, Live and In-stereo. The third Annual Computer Software Assurance 2023 aims to strengthen and empower Computer System Validation (CSV) and provide key insights on the CSA approach. 4. Break the industry myths concerning CSA.

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Pharma and Life Sciences Blog

APRIL 15, 2024

Our strategic consulting and managed services, powered by our industry-leading AI-first software platforms, set new benchmarks for excellence in procurement transformation. Read more about each report below.

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Express Pharma

SEPTEMBER 15, 2023

Blue Star Industrial Solutions, a division of Blue Star Engineering & Electronics, has forged a partnership with the Gebhardt Intralogistics Group, a German corporation. Blue Star Industrial Solutions specialises in quality testing and automation offerings and the collaboration with Gebhardt further strengthens its capabilities.

Packaging 52

Packaging 52

Express Pharma

JUNE 28, 2023

Over the years, the world of healthcare has evolved rapidly, and digital technology has played a crucial role in transforming the industry, including the way pharmacists operate. Additionally, such software also provide insights into customer preferences, including the best-selling products and the ones that are less popular.

Online Pharmacies 97

Online Pharmacies Customer Service Data Entry Packaging 97

pharmaphorum

MARCH 2, 2021

Clinical trial software facilitates clinical trials from conception to finish. The industry is now recognizing that to stay ahead of competitors, technological cloud-based clinical trial software solutions are key for faster, more efficient clinical trials. Types of clinical trial software. What is a CTMS?

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pharmaphorum

MAY 19, 2022

The Oxford, UK-based drug developer said it will make use of Empatica’s wearable devices and software in its studies to enrich the data it can harvest from them and hopefully improve patient outcomes and safety. The post Beckley adds digital element to its psychedelic drug trials appeared first on.

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Compounding Drug Development 103

pharmaphorum

NOVEMBER 1, 2022

It is the software that powers interoperability among various financial services brokers. A similar inflection point now faces the specialty pharmaceutical industry. Not unlike the financial industry, these institutions still exchange patient information via fax machines. and the financial wherewithal ?

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HIPAA Insurance Coverage and Processing Specialty Pharmacies Communication 98

Express Pharma

JULY 10, 2023

The Pharma Computer Software Assurance 2023 conference’s third edition was recently held at Novotel Mumbai, Juhu Beach, on 22-23 June, 2023. This session explored various aspects of CSA and CSV approaches in the pharma industry, providing insights from a regulatory as well as manufacturing perspective. CSV to CSA? CSV is CSA?”,

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Express Pharma

DECEMBER 1, 2023

Can you share some examples of innovative solutions or technologies that your company has developed for the pharma industry? This approach involves connecting machines and data to improve Overall Equipment Effectiveness (OEE) and maintain a leading edge in the industry. The future growth and development hinge on several opportunities.

Packaging 90

Packaging 90

pharmaphorum

JUNE 16, 2021

Many R&D teams have developed their own combination of partially or fully customised software and automation systems to better tackle these complexities, but overall movement of the industry towards such digital transformation has still been slow. So what is stopping the industry from adopting new ways of working?

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Viseven

MARCH 6, 2023

Nowadays, CRM system is an inevitable part of almost any online industry, and, of course, it’s crucial for healthcare and life science. This article will cover the main aspects of successful healthcare CRM software and its benefit. Such sensitive data inside healthcare CRM software should be stored according to HIPAA compliance.

Communication 52

Communication HIPAA Customer Service Hospitals 52

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Key changes to GAMP 5.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 84

pharmaphorum

FEBRUARY 11, 2022

Komodo Health’s president and co-founder, Web Sun, tells us about his company’s new partnership with the Chan Zuckerberg Initiative (CZI) to improve early diagnosis and advance research of rare diseases by providing CZI’s Rare as One Network healthcare data and software. For us, it’s operating at the intersection between data and software.

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pharmaphorum

SEPTEMBER 29, 2022

Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA regulates mHealth technologies that are medical devices, but the agency has adopted a risk-based approach to regulating mHealth technologies, such as medical device software. The FDA’s General Approach to Regulating mHealth Products.

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Documentation 96

European Pharmaceutical Review

MARCH 19, 2024

With a wider focus on sustainability in the industry, continuous bioprocessing aligns with these goals due to its ability to require less resources when compared to batch processing, the research stated. According to research by InsightAce Analytic Pvt. the global continuous bioprocessing market is expected to value $1,067.8 million by 2031.

Documentation 68

Documentation 68

pharmaphorum

NOVEMBER 30, 2022

Veeva Systems invited pharmaphorum to attend its industry summit in Madrid this week, a huge event that gathered together over 1,000 individuals from life sciences and pharma. Moore thanked everyone for coming in person for the 10 th anniversary of the summit, signifying a reconnection as an industry. Moore asked.

Communication 97

Communication 97

European Pharmaceutical Review

MAY 11, 2023

Delivering end-to-end expertise and solutions from research discovery to development, and diagnosis to cure, Revvity provides reagents, consumables, assays, instruments and software to customers in markets ranging from pharma and biotech , diagnostic labs, academia and government agencies. What’s ahead? Register here.

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European Pharmaceutical Review

MAY 10, 2024

A recent survey 1 of healthcare industry professionals showed that CGT is expected to have the most significant impact on the pharmaceutical industry in 2024. “The personalised nature of the industry means that AI is yet to have a tangible impact. Internet] GlobalData. cited 2024May]. cited 2024May].

Communication 86

Communication Hospitals 86

European Pharmaceutical Review

DECEMBER 4, 2023

The (bio)pharmaceutical industry is currently facing numerous hurdles in its path to high-efficiency production that are more complex and pressing than ever before. One of the most significant perceived challenges is the ability to implement new innovations and increase productivity while adhering to stringent regulatory demands. principles.

Pharmaceutical Manufacturing 89

Pharmaceutical Manufacturing 89

Express Pharma

FEBRUARY 8, 2024

The BEA awards are determined through industry voting of 30,000 professionals within the biopharma community. In the ever-evolving biopharmaceutical industry, continuous learning and professional development are paramount. The focus is on enhanced speed, reduced cost, and superior quality. The company generated revenue of $6.83

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Research Laboratories Vaccines 96

Express Pharma

MAY 15, 2024

Packaging and labelling, being an integral part of the products, are also transforming by adopting such contemporary technologies to remain at par with the industry standards across the globe. Since there is no artificial or arbitrary element in it and the level of intelligence is enhanced in this programme, I call it Augmented Intelligence.

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Packaging Labelling 86

pharmaphorum

NOVEMBER 2, 2022

Citeline provides intelligence, data and software for clinical trials, development and regulatory compliance and was formerly part of Informa was called Pharma Intelligence ahead of a rebranding earlier this year.

Drug Development 86

Drug Development Communication 86

European Pharmaceutical Review

MARCH 20, 2024

Increased concerns over data integrity , validity, and security are also contributing factors to the expansion of the European LIMS market, the report stated. Regional status of the LIMS market Germany is the largest revenue contributor to Europe’s LIMS market, according to the data.

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EnlivenHealth

APRIL 19, 2022

today announced the launch The post EnlivenHealth Launches Enliven360 Integrated Technology Platform appeared first on Pharmacy Software Solutions | FDS.

Omnicell 52

Omnicell 52

FDA Law Blog: Biosimilars

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g.,

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Documentation Labelling 98

EnlivenHealth

APRIL 22, 2022

The words “provider status” have been a fixture of pharmacy industry discussions for years. You make The post Why Provider Status for Pharmacists Should Be the New Normal appeared first on Pharmacy Software Solutions | FDS.

Vaccines 52

Vaccines 52

FDA Law Blog: Biosimilars

MARCH 11, 2024

Mullen — On February 20, 2024, FDA issued a letter to the medical device industry ( link ) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions. Unfortunately, the letter provides little new information to guide industry conduct.

Communication 64

Communication 64

pharmaphorum

JUNE 22, 2021

Labelling software firm has implemented six new software systems in the last few months in a sign that the market is now rebalancing after the upheavals of the last 12 months. PRISYM ID announces six further projects go live as medical device and life science organizations prepare for the future.

Labelling 52

Labelling 52

European Pharmaceutical Review

DECEMBER 21, 2022

This project will accelerate key parts of the MHRA’s recently published ‘ Software and AI as a Medical Device Change Programme – Roadmap’ , which is designed to ensure that medical device regulation is fit for purpose for software, including AI. The microbiome: unlocking the Fourth Industrial (Bio) Revolution.

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pharmaphorum

OCTOBER 27, 2021

Bayer’s two-year-old digital health collaboration with One Drop has borne its first fruit, an artificial intelligence-powered software module for preventing cardiovascular disease (CVD). ” The post Bayer, One Drop launch AI tool for heart disease prevention appeared first on.

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Diabetes Pharmaceutical Companies Pharmaceutical Companies 122

Viseven

JUNE 23, 2023

Industry leaders, innovation pioneers, and technology enthusiasts had a great chance to exchange knowledge, insights, and expertise with each other and get an immense charge of inspiration for the future of IT that will bring many positive changes. This year, Dublin Tech Summit was exceptional for Viseven as a Ukraine-based company.

Communication 52

Communication 52

Pharma Marketing Network

OCTOBER 18, 2023

The use of Artificial Intelligence (AI) in the pharma industry is increasing rapidly and has become a key component of digital marketing. AI is a type of computer software that is designed to simulate human intelligence and learn from its experiences. AI is used in many industries, including healthcare, finance, and retail.

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Customer Service Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

MAY 27, 2021

Life sciences software company Axtria has received a $150 million investment from Bain Capital Tech Opportunities to expand its suite of AI-platforms for omnichannel commercial operations. Founded in 2010, Axtria has emerged as a disruptive leader in the life sciences software space and recognised for its growth in the Inc.

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