STAT

NOVEMBER 1, 2023

A pharmaceutical company and its chief executive — who once defended Martin Shkreli for raising drug prices to controversial heights — agreed to pay up to $50 million to settle allegations of purposely underpaying Medicaid rebates. Department of Justice.

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

AUGUST 17, 2021

Sponsors and developers of AIs – including pharmaceutical companies – should set up governance structures to oversee algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product.

Documentation 116

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 116

Pharmaceutical Technology

JULY 19, 2022

In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, 19 (1.3%) referred to cloud computing.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 98

STAT

JANUARY 19, 2023

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.

Documentation 80

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 80

pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory.

Documentation 105

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 105

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

pharmaceutical company to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. pharmaceutical company achieve on time for Phase III clinical trials appeared first on SYNER-G.

Process Improvement 40

Process Improvement Pharmaceutical Companies Pharmaceutical Companies Documentation 40

Pharmafile

MAY 9, 2024

UK-based pharmaceutical company AstraZeneca has announced that is it voluntarily withdrawing its COVID-19 vaccine Vaxzevria due to a drop in global demand. The withdrawal also comes after AstraZeneca admitted in court documents that the vaccine can cause thrombosis with thrombocytopenia syndrome (TTS).

Vaccines 59

Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 59

The Checkup by Singlecare

DECEMBER 1, 2022

In order to test, market, and release drugs onto the market, pharmaceutical companies must abide by government regulations and oversight processes. . Regulatory affairs, however, encompasses more than just the pharmaceutical industry. Pharmacists who work in the private sector typically work for a pharmaceutical company.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 98

European Pharmaceutical Review

JULY 5, 2023

According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies.

Packaging 96

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 96

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

STAT

JUNE 5, 2023

Pharmaceutical companies that obtain a certificate can then use the document to satisfy customers — such as government agencies — that are increasingly incorporating environmental metrics in purchase agreements.

Documentation 68

Documentation Pharmaceutical Companies Pharmaceutical Companies 68

pharmaphorum

MARCH 26, 2021

Comms company Envision Pharma Group has acquired doDOC Corp, a document collaborative review, editing and authoring firm. doDOC enables simultaneous collaboration in the review, editing, and authoring of documents among multiple users.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

OCTOBER 20, 2020

The pandemic has triggered a change in how pharmaceutical companies are engaging with healthcare professionals. When IQVIA polled non COVID-19 treating Italian HCPs in March when the crisis was at its worst, it asked HCPs if they still welcomed pharmaceutical company engagement during the crisis. The answer was yes.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

pharmaphorum

FEBRUARY 10, 2021

Pharmaceutical companies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language. There may be a bit of a frenzy over the next few months as teams adapt to new concepts, language, new documents, SOPs, and clause numbers.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

Pharmaceutical Technology

AUGUST 26, 2022

Earlier this month, the World Health Organisation (WHO) released a new guidance document with a strategic plan to counter TB on a national level. Sequella is a US-based pharmaceutical company that develops antibiotics to address drug resistant infections. Sequella is developing SQ-109 for the treatment of pulmonary tuberculosis.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

SEPTEMBER 30, 2022

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them. Submission status quo.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Hospital Pharmacy Europe

AUGUST 17, 2023

GoCART aims to promote patient access to novel cellular therapies, bringing together different stakeholders, including healthcare professionals, health authorities, pharmaceutical companies, patient representatives, health technology assessment bodies, reimbursement agencies and medical non-profit organisations.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

ISPE

MARCH 16, 2023

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Automated systems offer a range of options for pharmaceutical companies. Environmental monitoring is another important aspect of Annex 1.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Compounding 98

Viseven

JULY 10, 2024

As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences. It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

STAT

AUGUST 16, 2023

So grab that cup of stimulation — our flavor today is butter pecan, a household favorite — and get started. Meanwhile, do keep us in mind if you hear anything interesting. We hope you have a simply smashing day and emerge unscathed. And the SEC wants to know whether Inotiv complied with the U.S.

Research Laboratories 70

Research Laboratories Documentation Pharmaceutical Companies Pharmaceutical Companies 70

pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. In 2014 Keith was fortunate to become a full-time salaried patient research ambassador at Liverpool Heart and Chest Hospital Trust.

Documentation 116

Documentation Pharmaceutical Companies Pharmaceutical Companies Hospitals 116

European Pharmaceutical Review

SEPTEMBER 26, 2023

Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.

Documentation 105

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 105

Pharmaceutical Technology

JULY 12, 2022

In total, the frequency of sentences related to digitalization between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,091 sentences, eight (0.7%) referred to digitalization.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

JUNE 28, 2022

In total, the frequency of sentences related to robotics between April 2021 and March 2022 was as frequent as in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, six (0.4%) referred to robotics.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 52

European Pharmaceutical Review

OCTOBER 3, 2024

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Documentation 52

pharmaphorum

OCTOBER 20, 2022

Executing an effective commercial success strategy requires extensive planning and implementation within pharmaceutical companies that spans teams, functions, and geographies. How can we take an innovative approach to drive commercial success across the pharmaceutical industry? Commercial excellence requires thoughtful planning.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Data Entry Documentation 98

Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. Selecting the best pharmaceutical wholesalers. Temperature control facilities and supply solutions. Warehousing and logistics services.

Documentation 52

Documentation Packaging Labelling Pharmaceutical Companies 52

Viseven

DECEMBER 4, 2024

Pharmaceutical validation involves evaluating each manufacturing stage to ensure that predefined standards are consistently met. It also requires documenting the entire process, from raw material sourcing to product launch. Process design should be based on solid evidence and include thorough documentation.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 52

Pharmaceutical Technology

AUGUST 9, 2022

In total, the frequency of sentences related to artificial intelligence between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 2,465 sentences, 24 (1%) referred to artificial intelligence.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

JULY 5, 2022

Mentions of the future of work within the filings of companies in the pharmaceutical industry were 373% higher between April 2021 and March 2022 than in 2016, according to the latest analysis of data from GlobalData. Of the document's 1,725 sentences, seven (0.4%) referred to the future of work.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

pharmaphorum

AUGUST 23, 2021

The possibility of data being shared with third-parties including academic researchers and pharmaceutical companies raised concerns about whether the public is aware that they stand to lose control of private information on their physical, mental and sexual health. Now that’s been set back indefinitely.

Medical Records 89

Medical Records Documentation Pharmaceutical Companies Pharmaceutical Companies 89

pharmaphorum

OCTOBER 18, 2021

Regulators and pharmaceutical companies are investigating cloud-based platforms to enable the real-time sharing of data. And advances in digitalisation could facilitate a move from document-based submissions to data-based submissions, through a cloud platform like the one being developed by Accumulus Synergy.

Vaccines 143

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 143

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication Documentation 52

The Checkup by Singlecare

APRIL 5, 2024

“Commonly, BCBS requires proof of a diagnosis of Type 2 diabetes and documentation that the patient has not adequately responded to other diabetes medications before approving Ozempic,” he says. When BCBS covers Ozempic, the out-of-pocket costs will vary based on the drug tier it falls in.

Insurance 78

Insurance Documentation Insurance Coverage FDA 78

pharmaphorum

AUGUST 16, 2021

Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. I can’t imagine that pharmaceutical companies will return to the ways of the past. This gives great risk for human error and misinterpretation. About the interviewee.

Documentation 98

Documentation Vaccines Packaging Pharmaceutical Companies 98

The Checkup by Singlecare

FEBRUARY 7, 2023

Eligible patients will be required to provide documentation of financial and insurance information to show they have no means of obtaining the medication without assistance. “Typically, these programs provide medications at little or no cost to those who qualify based on income and insurance status,” Dr. Staiger says.

Insurance 98

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98