European Pharmaceutical Review

MARCH 13, 2024

The data integrity violations API deviations in the microbiology lab The first deviation – failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures – relates to the lack of data integrity within the microbiology laboratory.

FDA 93

FDA Documentation 93

STAT

OCTOBER 4, 2023

At issue is a trial that Amgen is relying upon to win final approval for Lumakras, which the FDA approved on a conditional basis in 2021. But ahead of an advisory panel meeting on Thursday, the agency released documents showing its staff found “potential systemic bias” in the trial.

Documentation 124

Documentation FDA 124

Med Ed 101

JUNE 9, 2021

The post Preparing For The BCMTMS Exam in 2021-2022 appeared first on Med Ed 101. I’m happy with the testimonials that we have received that make me believe we provide the best resources on the market that […].

Documentation 40

Documentation 40

The FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are. Comments on the guidance are invited.

FDA 105

FDA Documentation Medical Records 105

STAT

DECEMBER 29, 2022

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

Insurance 98

Insurance Documentation FDA 98

European Pharmaceutical Review

JANUARY 17, 2023

The figures confirmed that in 2022, the UK remained a global leader in clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022. The number of Phase II/III trials increased from three trials in 2021 to seven trials in 2022. Over 80 percent, increasing from 131 trials in 2021 to 145 in 2022.

Documentation 105

Documentation 105

European Pharmaceutical Review

NOVEMBER 21, 2022

Study data from Elsevier’s abstract and citation database Scopus, identified that 2,450 papers were published in 2021 on the pathogen WHO identified as most critical, Acinetobacter baumannii (carbapenem-resistant). Enterococcus faecium : 1,246 in 2021 versus 730 in 2017. Neisseria gonorrhoeae : 731 in 2021 versus 478 in 2017.

Documentation 93

Documentation 93

ISPE

MARCH 23, 2023

A True Copy is an exact copy of original documentation that preserves the same content, meaning and attributes of the original. It is an electronic copy maintained in an electronic document management system. This negates the requirement for storage of paper evidence and correct GMP document management of these hardcopy evidences.

Documentation 98

Documentation FDA 98

Pharmaceutical Technology

JULY 19, 2022

Mentions of cloud computing within the filings of companies in the pharmaceutical industry rose 65% between the final quarter of 2021 and the first quarter of 2022. Of the 10 biggest employers in the pharmaceutical industry, IQVIA was the company which referred to cloud computing the most between April 2021 and March 2022.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 98

IDStewardship

OCTOBER 28, 2022

Develop a manual or guidance document outlining the goals of the account. This type of document is especially helpful for account management transitions in resident managed accounts. Multiple pharmacy organizations have guidance or best practice documents pertaining to social media use. UKPharmRes. BIDMCPharmRes. MayoPharmRes.

Documentation 229

Documentation 229

The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

FDA 108

FDA Documentation Vaccines 108

Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database. AbbVie reported a 22.7%

Vaccines 108

Vaccines Documentation Compounding FDA 108

pharmaphorum

JULY 6, 2021

Oxford Nanopore is also building up to an initial public offering (IPO) later this year that could reinforce 2021’s position as the best-ever year for UK financing, well ahead of last year’s total tally of £2.81 Source: BIA, Clarivate.

Documentation 141

Documentation Vaccines 141

pharmaphorum

SEPTEMBER 2, 2020

The guidance published on the Medicines and Healthcare products Regulatory Agency (MHRA) website is broadly similar to arrangements laid out in a Brexit “no deal” document published last year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

Documentation 123

Documentation Labelling 123

pharmaphorum

DECEMBER 4, 2020

In a separate announcement, rival vaccine firm Moderna said it expected to have between 100 and 125 million doses available globally in the first quarter of 2021. The company said it is still on course to manufacture between 500 million and up to a billion doses of the vaccine globally in 2021.

Vaccines 122

Vaccines Documentation FDA 122

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 78

Adverse Reactions Documentation Medical Schools Packaging 78

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs.

Documentation 94

Documentation FDA 94

Pharmaceutical Technology

APRIL 6, 2023

Accord US BioPharma president Chrys Kokino said: “The promise of HLX02’s reference product — Herceptin1 — is well documented, and we’re thrilled to announce this regulatory milestone as we work to provide patients increased options and access for treatment of serious conditions in oncology, immunology and critical care.

FDA 52

FDA Documentation 52

Pharmaceutical Technology

JUNE 28, 2022

Mentions of robotics within the filings of companies in the pharmaceutical industry fell 22% between the final quarter of 2021 and the first quarter of 2022. Of the 10 biggest employers in the pharmaceutical industry, J&J was the company which referred to robotics the most between April 2021 and March 2022. of all sentences.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 52

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. But while amending processes and documentation to suit the 2021 code won’t be easy, the task doesn’t have to be as overwhelming as it first appears, she said.

Documentation 109

Documentation Pharmaceutical Companies Pharmaceutical Companies 109

ISPE

NOVEMBER 2, 2022

Jörg Zimmermann, International Board Chair for 2021–2022 and Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co., ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Past Chair.

Documentation 52

Documentation Compounding Communication FDA 52

The FDA Law Blog

OCTOBER 5, 2022

eSTAR employs targeted questions to collect specific data and information and includes applicable links to regulations, relevant guidance documents, and other resources. With the exception of points 1 and 5 above, these are not different from when the draft guidance came out in September 2021.

Documentation 45

Documentation FDA 45

pharmaphorum

APRIL 28, 2021

Speakers at the 24 May 2021 event entitled ‘True Validation Ready Labeling – What it Really Means’ include Phil Dray, Test Manager at PRISYM ID, and two further independent experts who have long experience in cloud-based systems and regulatory compliance. . . “Yet Experts to come together for compliance event .

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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

pharmaphorum

FEBRUARY 12, 2021

If 2020 was the year that cemented the role of virtual advisory boards and virtual engagement in many forms, then we believe that 2021 will be the year of ‘virtual co-creation’. Well, at least for 2021! But there are many other ways in which a VAB platform can enhance digital interactions and engagements with KOLs and HCPs.

Documentation 57

Documentation 57

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 15, 2022

The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

Insurance 131

Insurance Documentation Packaging 131

PharmaShots

JUNE 14, 2023

The diagnostic and testing companies have been serving as a pivotal foundation stone of the healthcare sector With a global market value of $165.58B in 2021, the diagnostic and testing market size is anticipated to touch the threshold of $348.75 Varex’s 2022 diagnostic segment revenue increased by 4.69% as compared to 2021.

FDA 56

FDA Hospitals Documentation Patient Care 56

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

European Pharmaceutical Review

NOVEMBER 15, 2022

Access opportunities in key policy areas created through IGBA’s blueprint: Biosimilars access was acknowledged as one of four key areas in IGBA’s 2021 Biosimilar medicines Access Policy Blueprint , which aimed to enhance regulatory efficiencies for greater access. Enhancing Regulatory Efficiency – greater access.

Documentation 93

Documentation 93

pharmaphorum

DECEMBER 16, 2020

The document has been published just after the US started the rollout of Pfizer and BioNTech’s vaccine after it got an emergency green light last week, and ahead of an expert panel due to consider Moderna’s shot on Thursday. The post FDA backs Moderna COVID-19 shot ahead of emergency use vote appeared first on.

FDA 98

FDA Vaccines Documentation 98

pharmaphorum

JUNE 3, 2021

This article appears in our digital magazine Deep Dive: Market Access 2021. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too. Leela Barham takes stock. Read below for a preview: NICE has never stood still since it started its work in 1999.

Documentation 98

Documentation 98

pharmaphorum

NOVEMBER 16, 2021

NICE notes in its final appraisal document (FAD) for the drug that many patients with this form of epilepsy may have to try a range of medicines, both alone and in combination, in order to control seizures. An opinion from the Scottish Medicine Consortium (SMC) on the use of the drug by NHS Scotland is expected to be published early in 2022.

Documentation 98

Documentation 98

pharmaphorum

MAY 16, 2022

In 2020, USAID launched two policy documents to guide how the agency invests in digital infrastructure as part of its development and humanitarian assistance programmes: Digital Strategy and Vision for Action in Digital Health (aka Digital Health Vision). “Economists in 2021 estimated the pandemic cost the world over $11 trillion.

Documentation 115

Documentation Vaccines 115

Hospital Pharmacy Europe

AUGUST 7, 2023

In 2008, the American Society of Health-System Pharmacists published a document outlining the activities that pharmacy services in EDs should provide, which was subsequently updated in 2021. These priorities are based on the available scientific evidence and the experiences of physicians and pharmacists working in the field.

Patient Care 98

Patient Care Hospitals Documentation 98

pharmaphorum

JANUARY 12, 2021

2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. It’ll also reveal just what the Target Development Profile (TDP) living document will cover and how it can evolve over time. That makes it a target for June 2021.

Documentation 70

Documentation 70

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world.

FDA 92

FDA Documentation Compounding Pharmaceutical Companies 92