STAT

MAY 16, 2023

2, the Food & Drug Administration issued an alert warning about “Made in India” artificial eye drops that were potentially contaminated with rare drug-resistant bacteria suspected to be the cause of 55 adverse events, including three deaths and several other cases of vision loss from eye infections.

Documentation 98

Documentation FDA 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.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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.

Documentation 59

Documentation 59

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?

FDA 105

FDA Documentation 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.

Vaccines 103

Vaccines Documentation FDA 103

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.

Documentation 75

Documentation 75

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.,

Documentation 40

Documentation Patient Care 40

The Happy PharmD

OCTOBER 26, 2022

All events that jeopardized a patient’s safety, such as those involving falls, wrong surgical sites, clinical alarm mishaps, and other safety-related problems could result in a sentinel event. They were called sentinel events because of the immediate need for attention to address these errors. Every case was a sentinel event?

Hospitals 52

Hospitals Labelling Medical Records Documentation 52

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.

Labelling 98

Labelling Documentation FDA 98

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”.

Documentation 96

Documentation 96

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.”.

Documentation 111

Documentation FDA 111

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.

Documentation 111

Documentation Labelling Hospitals 111

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.

Documentation 105

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 105

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

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.

Documentation 140

Documentation Communication Hospitals 140

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.

Documentation 105

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.

Documentation 98

Documentation 98

pharmaphorum

NOVEMBER 11, 2022

According to court documents, Cohen reached out in 2015 to Moshe Alafi, former general partner at Alafi Capital who he had known for decades – and his son Christopher Alafi, who is the firm’s capital director – to seek investment in Nuredis. .

Documentation 113

Documentation FDA 113

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.

Hospitals 96

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,

Documentation 98

Documentation Insurance 98

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.

Patient Care 98

Patient Care Hospitals Documentation 98

Hospital Pharmacy Europe

AUGUST 17, 2023

11,12 In addition, due to the complexity of these therapies, pharmacists must ensure adequate training during their implementation, management and monitoring of toxicities and adverse events, and effective collaboration with all members of the multidisciplinary team.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 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.

Documentation 52

Documentation Process Improvement FDA 52

The Checkup by Singlecare

MARCH 10, 2025

Certain insurance plans (such as ones from Blue Cross Blue Shield and United Healthcare ) may cover Ozempic but require prior authorization for coverage, meaning the prescriber needs to provide information such as blood tests or documentation to prove a treatment is medically necessary. affected by a shortage). mL of 5 mg/0.5 mL of 5 mg/0.5

Compounding 52

Compounding Insurance Insurance Coverage FDA 52

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.

Independent Pharmacies 52

Independent Pharmacies Documentation 52

The FDA Law Blog

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

Labelling 64

Labelling FDA Communication Documentation 64

pharmaphorum

JUNE 2, 2021

The document – which is available in digital or paper form – will be “free of charge, secure and accessible to all,” according to the European Commission, and may be scanned at the point of departure or arrival within the EU. .”

Vaccines 96

Vaccines Documentation 96

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.

FDA 105

FDA Documentation 105

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?

Documentation 98

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.

Insurance 96

Insurance Insurance Coverage Labelling Medical Records 96

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.

Hospitals 52

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?

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies 98

Pharma Marketing Network

MARCH 18, 2025

Best For: Thought leadership, industry networking, and professional event promotions. Keep Detailed Records of PPC Campaigns Document ad approvals, compliance reviews, and campaign changes to maintain transparency in case of audits. Targeting Options: Job title, seniority, skills, company size, and industry.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 52

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.

Documentation 105

Documentation 105

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

Documentation 132

Documentation 132

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.

Documentation 52

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?

Documentation 91

Documentation 91