pharmaphorum

JUNE 22, 2021

The UK’s Department of Health and Social Care has published a document setting out its strategy on handling patient data – and defending its plan to transfer millions of GP records into a centralised database. — Matt Hancock (@MattHancock) June 22, 2021. — medConfidential (@medConfidential) June 22, 2021.

Documentation 52

Documentation Health and Personal Care Stores Medical Records Communication 52

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.

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Documentation Drug Pricing 246

pharmaphorum

DECEMBER 22, 2021

As part of our 2021 in Review series, we look back over some of these developments. The document also states the importance of real-world data in understanding how currently available pharmaceutical products work in different populations. Education and empowerment allow for equal access to care. Looking ahead.

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Documentation 105

Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. The courts also had a busy year in 2021. Introduction. c) Other policy developments.

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Documentation Labelling Vaccines Packaging 52

Med Ed 101

MARCH 10, 2021

This document […]. The post Heart Failure Guideline Updates in 2021 appeared first on Med Ed 101. Prior to the full guideline release, the organization recently printed their updated Expert Consensus Decision Pathway for treatment of patients with heart failure with reduced ejection fraction (HFrEF).

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Documentation 40

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.

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Documentation 68

Drug Channels

MARCH 16, 2021

I am pleased to announce our new 2021 Economic Report on U.S. Drug Pricing, Reimbursement, and Patient Costs (press release) We’re offering special discounted pricing if you order before March 28, 2021. The 2021 Economic Report on U.S. The full document clocks in at 412 pages. d/b/a Drug Channels Institute.

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Drug Pricing Documentation 52

Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. The notable new material in this 2021-22 edition includes three new sections: Section 4.2.5. Copyright © 2006-2021 Pembroke Consulting, Inc. Section 4.4.

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Biosimilars Pharmaceutical Manufacturing Hospitals Documentation 61

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

BioPharma Dive

AUGUST 14, 2023

The regulator has asked for documents tied to the 2021 deal as well as to the conduct and compensation of Illumina and Grail management.

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Documentation 52

Express Pharma

DECEMBER 5, 2023

Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and US FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl. Sentynl now assumes full responsibility for the development and commercialisation of CUTX-101.

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STAT

JULY 24, 2023

Of 173 drug appraisals conducted by the National Institute for Health and Care Excellence since April 2021, 138 involved patient groups with a financial link to the maker of the drug being assessed, or have since received funding. Financial interests were often not clearly disclosed in NICE documents.

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Drug Pricing Documentation 200

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.

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Documentation Pharmaceutical Manufacturing 91

ALiEM - Pharm Pearls

JANUARY 26, 2024

Ciprofloxacin has been documented as a cause of IgA vasculitis. 2021 Jan;34(1):e14591. Case Question: What are common triggers for this diagnosis? Common triggers include infection, drugs, and autoimmune. Case Discussion Take-Home Points Consider IgA vasculitis, even in an older patient. Ann Pharmacother. 1995 Jan;29(1):84.

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Nursing Homes Documentation Hospitals 183

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 […].

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Documentation 40

Express Pharma

AUGUST 23, 2023

The researchers tracked infections among 15,444 residents of Connecticut correctional facilities between June 2021 and May 2022, when the state experienced two epidemic waves due to the emergence of the COVID-19 Delta and Omicron variants.

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Vaccines Documentation Immunity Immunization 94

FDA Law Blog: Biosimilars

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.

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Documentation Medical Records 105

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.

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Documentation 103

Pharma in Brief

JANUARY 18, 2021

The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Prior to the January 6, 2021 amendment, the list of jurisdictions included the European Union and its member countries, along with the United States, Australia, Switzerland, and Japan. There are also certain timing requirements.

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Documentation 52

Pharma Pathway

DECEMBER 12, 2022

Passed out years: 2020/2021/ 2022. Kindly Carry the below Documents with you: . Division: OSD-Formulation. Qualification: ITI, Diploma, B.Sc, B.Com. Location: Hyderabad. Date: 14th Dec’ 2022. Time: 9:00 AM to 01:00 PM. Venue: Granules India Limited, Gagillapur , Dundigal- Gandimaisamma- Malkajgiri , Hyderabad , Telangana – 500 043.

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Pharmaceutical Manufacturing Documentation 86

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 91

Documentation 91

Drug Channels

DECEMBER 2, 2021

This book provides a comprehensive, well-written chronicle of the COVID-19 pandemic (as of mid-2021). Dr. Gottlieb documents—with great specificity—how and why our government’s public health infrastructure failed us during the pandemic. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. Amazon link). to 1:30 p.m.

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Documentation 58

Pharma Pathway

JANUARY 27, 2023

Ltd-Walk-In Interview for Freshers & Experienced On 28th Jan’ 2023 Job Description Walk-In Interviews for Production & Production Documentation @ Neuland Laboratories Pvt. Ltd Department: Production & Production Documentation Designation: Chemist Experience: 2 to 6 years Qualification: M.Sc / B.Sc 10, Plot No.

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Documentation 78

Pharma in Brief

JANUARY 20, 2021

On January 18, 2021, the Federal Court ( FC ) issued its latest COVID-19 Practice Direction , which supersedes all its prior COVID-19 practice directions. Also on January 18, 2021, the FC issued a new Practice Direction outlining its Document Retention Schedule, including new plans for the destruction of certain archived documents.

Documentation 52

Documentation 52

Pharma in Brief

JANUARY 12, 2022

Amendments to the Federal Courts Rules (the Amended Rules ) were registered on December 13, 2021 and officially published in the Canada Gazette Part II on December 22, 2021. The Amended Rules come into force on January 13, 2022. Key Changes and Additions.

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Documentation 52

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.

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Omnicell Pharmaceutical Companies Pharmaceutical Companies Documentation 98

RX Note

APRIL 2, 2023

Many Links in One Place At your workplace, have you thought to put all the useful links (including Google drive documents) at one place to ease accessibility? linktree Pallyy Shorby External Links The 8 best URL shorteners of 2021, 2021 9 Best Instagram Bio Link Tools For 2021 (Expert Picks), 2021

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Documentation 52

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.

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Diabetes Biosimilars Documentation Compounding 205

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 Drug Pricing Biosimilars Documentation 108

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

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Dosage Inpatient Packaging Documentation 111

FDA Law Blog: Biosimilars

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.

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Documentation Vaccines Drug Development 108

Pharma Marketing Network

APRIL 30, 2021

At this year’s Reuters Pharma Clinical 2021, I joined over 500 global leaders in clinical research as they discussed many of these issues under the theme, “rebuild clinical trials in the image of patient need.”. How do we increase the diversity of clinical trials?

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

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.

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Documentation Vaccines 141

FADIC

OCTOBER 20, 2023

If possible, the patient can document the name and personal details of the physician who made the prescription. Documentation and follow up At all stages, the pharmacist should ensure that all interventions are well documented. Over-the-counter items should be added to the list, and the time they were administered. References 1.Chaar,

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Health and Personal Care Stores Documentation Medical Records Hospitals 95

Pharma in Brief

JULY 7, 2021

On June 17, 2021, a series of amendments to the Federal Courts Rules (the Amended Rules ), were registered and came into force. On July 7, 2021, the Amended Rules were officially published in the Canada Gazette Part II.

Documentation 52

Documentation 52

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

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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. The importance of using plain language in health communications is well-documented in literature.

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Documentation Communication Mayo Clinic Drug Development 52