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

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?

Documentation 105

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.

Vaccines 103

Vaccines Documentation FDA 103

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

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 Improved control reduces the risk of misinformation, or having teams send outdated or incorrect information to partners.”.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

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

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

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

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

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

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

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

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

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

European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

Documentation 97

Documentation Pharmaceutical Companies Pharmaceutical Companies 97

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

pharmaphorum

NOVEMBER 23, 2022

Harking back to the Reuters Pharma 2022 event, held at the Nice Acropolis convention centre on France’s South Coast back in October, pharmaphorum had a chance to drop by the booth of EY and discuss not only its consulting operations, but the company’s Smart Reviewer, and their own assessment of the industry event itself.

Documentation 98

Documentation Dosage Vaccines Hospitals 98

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.

Documentation 98

Documentation FDA 98

DiversifyRx

OCTOBER 20, 2022

’ You want to ensure that you document the attestation every time you dispense the at-home COVID tests for a patient. People don’t want to needlessly isolate themselves and miss work and life events. Do not just autofill all these at-home tests and ship them out if the patients do not want them.

Insurance 98

Insurance Packaging Documentation Communication 98

PQA

MARCH 8, 2024

We are in the early stages of planning an event, PQA Convenes: Quality Medication Use in Rare Disease, which will bring our members and the rare disease community together to explore quality in medication use. This one-day event will take place on Thursday, November 7, 2024, in Arlington, Va., Learn more below.

Community Pharmacies 52

Community Pharmacies Specialty Pharmacies Independent Pharmacies Documentation 52

ISPE

SEPTEMBER 1, 2023

In the event of inaccessibility, a business continuity plan should be in place including potential production risks and decision tree. Furthermore, there should be an evaluation of the cloud service provider to verify potential impact to product quality and/or data integrity in the event of inaccessibility.

Communication 98

Communication Documentation 98

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.

Documentation 105

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 105

IDStewardship

AUGUST 17, 2022

I like when presentations and documents are sent in advance, but that is not always feasible. Like the famous basketball player Michael Jordan said – Champions don’t become champions when they win an event, but in the hours, weeks, months and years they spend preparing for it. That means putting in the work on the back-end.

Documentation 130

Documentation 130