OctariusRx

APRIL 1, 2025

OctariusRx President and Consultant Pharmacist Victor Alves is presenting Pharmacy Documentation: Tips for Patient Safety and Survey Success at the ASCA 2025 Conference & Expo, April 30May 3, in Denver Colorado. He will discuss the essential elements of patient safety through complete pharmacy documentation.

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Documentation 68

STAT

JANUARY 7, 2025

The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs.

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FDA Compounding Documentation 102

ISPE

FEBRUARY 14, 2023

This blogpost will summarize inspection topics for presenting digital CQV content and provide a list of common questions encountered during inspection events. During paper-based inspection events, a CQV package is requested and a printed report with a physical binder are brought in to support the request.

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pharmaphorum

MAY 25, 2022

When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. The same cannot be said for online events.

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Fierce Pharma

AUGUST 28, 2023

It’s been well documented how Novo Nordisk has had difficulty in meeting the soaring demand for its GLP-1 weight loss treatments.

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Documentation 98

pharmaphorum

APRIL 28, 2021

Experts to come together for compliance event . The complimentary online event, hosted by PRISYM ID, will explain best practice in the implementation of validation ready, cloud-based, global labeling systems. . . The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.

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The FDA Law Blog

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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Documentation FDA Adverse Reactions Communication 105

pharmaphorum

DECEMBER 10, 2020

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting.

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Vaccines Documentation FDA 103

The Checkup by Singlecare

DECEMBER 6, 2024

When taken together, the risk of these adverse events can increase. Alcohols negative effects on the liver are well-documented. Dangers of mixing clonidine and alcohol There are a few reasons why its not recommended to drink alcohol while taking clonidine. First, clonidine and alcohol share some similar side effects.

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Labelling Documentation FDA 98

PQA

MARCH 12, 2025

A draft call to action was created using findings from an environmental scan and a PQA Convenes event. 1-2 years) Increase standardized HIT for documentation of MTM services Re-establish consensus on standards for clinical documentation for MTM services (e.g.,

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PharmD Live

JUNE 2, 2025

Proven Track Record: Documented success, strong references, and positive client outcomes. Action Steps: Protecting Your Practice in 2025 Vet RPM Vendors Rigorously: Demand transparency, compliance documentation, and references. Full-Service Delivery: Education, device supply, and treatment management for every patient.

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pharmaphorum

JANUARY 6, 2023

Kelly Traverso, vice president, Veeva Vault Safety Strategy, and consulting, predicts that “in 2023, companies will broaden their focus beyond safety data to include all the content and documents that come with it. Improved control reduces the risk of misinformation, or having teams send outdated or incorrect information to partners.”.

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Documentation FDA 111

European Pharmaceutical Review

APRIL 10, 2024

The regimen may be applied as a quality indicator fulfilling certain ISO quality control criteria, and offers “documented, systematic feedback”. Additionally, a laboratory could assume that a partially degraded nucleic acid “is a consequence of upstream preanalytical events rather than contamination in their laboratory”.

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pharmaphorum

OCTOBER 12, 2022

Facilities can be asked to provide documented records of environmental monitoring, as well as personnel interaction with systems of record and the order in which events occurred. Presentation of data is vital when regulators carry out formal inspections.

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pharmaphorum

SEPTEMBER 23, 2020

That’s according to the team at Sweden’s Sahlgrenska Science Park, who are getting ready to host a virtual event looking at how the specialisation of digital expertise is driving a trend of sector convergence that pharma is only just cottoning on to. Innovation versus regulation. For more information visit the Park’s website.

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The FDA Law Blog

OCTOBER 3, 2022

Mr. Bawduniak claimed that these events were held at “sumptuous resorts and restaurants” and involved “lavish meals and free alcohol.” Today, these two documents are key in navigating speaker programs in the industry.

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Documentation 105

pharmaphorum

JULY 15, 2022

The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 mmol/litre or above) in their blood who are already taking statins.

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Documentation 98

European Pharmaceutical Review

JUNE 12, 2024

MBK-01 demonstrated a greater clinical benefit than fidaxomicin when used as the first choice for treatment of the current CDI episode event without any antibiotic treatment. Additionally, MBK-01 did not increase the frequency of adverse events (AEs) commonly associated with CDI or antibiotic treatment and was well tolerated.

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European Pharmaceutical Review

JANUARY 19, 2023

The final appraisal document (FAD) recommended the triple regimen as an option for adult patients who have received two or three lines of therapy. Adverse events (AEs) observed in the ixazomib arm were consistent with reported safety profiles for the individual agents.

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Hospitals Documentation 96

pharmaphorum

OCTOBER 7, 2022

As we enter October and the Frontiers Health 2022 conference in Milan, we’re shining a spotlight on some of the Steering Committee members who have helped make the event what it is. And check out DTx and National Health Systems from last year’s event below. A cooling off in digital health investment. “Yet,

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Fuld

MARCH 12, 2025

This comprehensive resource provides a detailed calendar of key healthcare conferences happening across the US and Europe in 2025, all in a single, easy-to-access document. Whats inside?

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Documentation Patient Care 52

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. Involving pharmacists in care coordination reduces adverse events and eliminates unnecessary medical costs.

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Patient Care Hospitals Documentation 98

European Pharmaceutical Review

AUGUST 3, 2023

Rather than focusing on documentation with the aim to achieve compliance, the initial proposed framework shined a light on problem-solving and therefore the initiation of preventative action as a key part of the process. These results are included in most recent paper.

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DiversifyRx

SEPTEMBER 26, 2024

Documenting Business Meetings Having business meetings isn’t enough; you must document them properly if you want to protect your corporate veil. This documentation proves that your business decisions are made formally and thoughtfully rather than haphazardly. – Signatures: Have all attendees sign the document.

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Independent Pharmacies Documentation 52

The FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

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European Pharmaceutical Review

JULY 21, 2023

The document is part of the joint Heads of Medicines Agencies (HMA)-EMA Big Data Steering Group (BDSG) initiatives to develop the European Medicines Regulatory Network’s capability in data-driven regulation. How can AI be best harnessed for pharmacovigilance data?

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Documentation FDA 98

The Checkup by Singlecare

JUNE 28, 2024

It’s also approved to reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus and established cardiovascular disease. Managing blood sugar and reducing the risk of major adverse cardiovascular events in people with Type 2 diabetes are the only FDA-approved uses for Ozempic.

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Hospital Pharmacy Europe

DECEMBER 17, 2024

S erious adverse drug events are unfortunately common in hospitals and can occur across all stages of the medication delivery process. Right documentation. Right patient 2. Right medication 3. Right dose 4. Right time 5. Right route 6.

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Hospitals Patient Care Medication Delivery Documentation 52

pharmaphorum

OCTOBER 5, 2022

He’s been involved with the event from the early days, and he says he sees different ways in which pharma could integrate digital therapeutics. So, in France, if I’m under an oncology medication, I have an app, and there’s an improved survival documented in the RCP. What will the market dynamics of DtX look like?

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pharmaphorum

AUGUST 10, 2021

“COVID-19 has brought challenges to the way cancer treatments and clinical trials are delivered across Scotland and it is clear that collaboration will be required to ensure care returns to pre-pandemic levels,” said a report of the event.

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pharmaphorum

APRIL 6, 2021

The blog, which covers lifestyle topics and reviews events and products, was even nominated for a National Diversity Award last year. “It It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says. “It

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The Checkup by Singlecare

JUNE 5, 2025

It is also approved to reduce the risk of major adverse cardiovascular events in adults who have cardiovascular disease and are either overweight or have obesity. More insurance plans are starting to cover Wegovy, although they may be more likely to cover it for cardiovascular risk reduction than for weight loss alone.

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Insurance Documentation Hospitals FDA 52

pharmaphorum

MAY 5, 2022

Following on the success of the previous West Coast events, we are delighted to announce 5th Annual Pharmaceutical Microbiology West Coast conference taking place in San Diego on June 20th and 21st,2022. Event Hashtag: #PharmaMicroWC. Sponsored by: Associates of Cape Cod, Bioscience International and Ecolab. Key Reasons to Attend: 1.

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Documentation 52

ISPE

SEPTEMBER 8, 2023

With the COVID-19 pandemic, various natural disasters, and other unforeseen large-scale events, the importance of ensuring drug supply chain has never been more apparent,” said Tom Hartman, President and CEO of ISPE. What do you love about your job?

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ISPE

MARCH 3, 2023

Watson Elena Vulpe 3 March 2023 GAMP ® 5 (Second Edition) was published on 29th July 2022 and was presented and discussed at the 2023 ISPE Annual Meeting and at several local GAMP ® events held around the globe. Computer System Validation should not be a hindrance to innovation.

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Documentation FDA 98

The Checkup by Singlecare

AUGUST 29, 2024

Facial rashes and redness aren’t listed as adverse effects in Dupixent’s clinical trials, but they’re well-documented in case reports and other research. However, other adverse events are less obvious. As such, Dupixent isn’t a broad immunosuppressant like other eczema drugs , so it won’t increase the risk of infections.

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European Pharmaceutical Review

SEPTEMBER 26, 2023

Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon. In this role, Graeme is responsible for all pharmacovigilance (PV) systems that facilitate adverse event data collection and reporting.

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