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.

Documentation 104

Documentation Communication Labelling 104

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 74

Documentation 74

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

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

PQA

DECEMBER 14, 2023

Informed by a robust environmental scan and a November 2 national convening event, PQA has drafted a call to action that includes eight elements. Strengthen requirements for standardized documentation and reporting related to the quality of MTM services. You can read more about each of these in the draft call to action document.

Documentation 45

Documentation 45

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.

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FDA Documentation Vaccines 108

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 101

Vaccines Documentation FDA 101

The Checkup by Singlecare

NOVEMBER 9, 2023

This person may go by other names in the document, depending on the state you live in. The benefits of a medical power of attorney Having a signed and notarized medical power of attorney offers many perks, and it is one of the most important documents you’ll create in a lifetime.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Communication Hospitals 52

Hospital Pharmacy Europe

APRIL 25, 2024

Workplace environments must support ‘psychological safety and [enable] individuals to feel confident, supported and empowered to speak up and raise patient safety incidents without fear’, the document added. Additionally, it can be used to identify sustainable system improvements, with facilitation of both shared and individual learning.’

Community Pharmacies 52

Community Pharmacies Hospitals Documentation 52

PQA

SEPTEMBER 25, 2023

This invite-only event will bring together PQA members and industry experts to discuss the state of medication therapy management (MTM) practice, implications of recent Centers for Medicare & Medicaid Services (CMS) proposals and opportunities to evolve MTM quality measurement. The survey and environmental scan will inform PQA Convenes.

Documentation 40

Documentation 40

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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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

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

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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Documentation Packaging 52

Hospital Pharmacy Europe

JANUARY 4, 2023

Being infected with herpes zoster increases the long term risk of a major cardiovascular event such as a stroke and the development of coronary heart disease, according to an analysis from three large, prospective studies by researchers from Harvard Medical School, Boston, US. Herpes zoster infection and cardiovascular events.

Medical Schools 52

Medical Schools Documentation Hospitals 52

Omnicell

JANUARY 10, 2023

So why, as clinicians, are we not focused on improving the documented one in 10 inaccuracies in sterile compounded products? It’s well documented that manual processes are archaic and inaccurate, and organizations like ISMP, ASHP, and many others agree things need to change. Or the airlines lost 10% of passenger bags.

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Sterile Compounds Compounding Omnicell Documentation 52

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

PQA

MARCH 22, 2023

This in-person, one-day event, “PQA Convenes: Advancing the Quality of Medication Therapy Management,” will take place at the Renaissance Arlington Capital View, in Arlington, Va., This special event precedes the 2023 PQA Leadership Summit, which is November 2-3 at the same location. from 9:00 a.m.-2:00 data sources), and usability.

Documentation 52

Documentation 52

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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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 103

ISPE

APRIL 19, 2023

Organize and plan the work: identify who is going to do each task, specify the deadlines to deliver, estimate the available resources, and foresee how to react to possible unforeseen events. This strategy, and which test is susceptible to carry it out or not, must be set out in a document and this activity corresponds to the PM.

Documentation 52

Documentation Communication 52

PQA

SEPTEMBER 25, 2023

We continue to play a central role in driving meaningful improvements and positive changes related to medication safety, adherence and appropriate use.The 2023 PQA Annual Report documents our progress towards Blueprint PQA 2025. These events is an invitation-only event for PQA member organization leaders.

Specialty Pharmacies 52

Specialty Pharmacies Documentation Patient Care Immunization 52

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

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

PQA

JULY 28, 2023

For patients with multiple chronic conditions and taking many chronic medications, MTM can help achieve the best therapeutic outcomes while reducing the risk of adverse events. We plan to open registration for this invitation only event on August 15, and we’ll share more details at that time.

Documentation 40

Documentation 40

PQA

JULY 28, 2023

A key part of this effort is a November 2 PQA Convenes event will will host. Community events are also popular. We plan to open registration for this invitation only event on August 15 and will share more details at that time. Event and registration details will be shared in the coming weeks. Learn more below.We

Documentation 40

Documentation Vaccines 40

Hospital Pharmacy Europe

MARCH 13, 2024

The primary endpoint was progression-free survival , defined as the time from randomisation to the first documentation of disease progression or death. In terms of safety, Grade 3 or 4 adverse events occurred in a similar proportion of participants in the two groups (96.6% male) receiving cilta-cel. vs. 15.6%).

Documentation 52

Documentation Hospitals 52

pharmaphorum

JANUARY 13, 2023

At the moment the threshold for prescribing these drugs to a patient is a 10% or greater risk over 10 years of a cardiovascular event such as a heart attack or stroke. A daily 20 mg does of atorvastatin – available as a low-cost generic – is the statin of choice for primary prevention, according to the document.

Documentation 52

Documentation 52

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

PQA

JUNE 16, 2023

Learn more about this convening event below. This in-person, one-day event, “PQA Convenes: Advancing the Quality of Medication Therapy Management,” will take place at the Renaissance Arlington Capital View, in Arlington, Va., Additional information about this PQA Convenes event will be shared by August. on November 2.

Documentation 40

Documentation Vaccines 40

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 75

pharmaphorum

JANUARY 30, 2023

Network with the industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insights.

Documentation 52

Documentation 52

Hospital Pharmacy Europe

JUNE 9, 2023

Researchers set the primary outcome as PFS, defined as the time from randomisation to the first documentation of disease progression or death. In terms of safety, Grade 3 or 4 adverse events occurred in a similar proportion of participants in the two groups (96.6% male) receiving cilta-cel. vs. 15.6%).

Documentation 52

Documentation Hospitals 52

pharmaphorum

DECEMBER 14, 2022

.” The experts reviewed data from the GALACTIC-HF trial, conducted when Cytokinetics was partnering the drug with Amgen, in which the drug met its primary objective of reducing cardiovascular death or heart failure events compared with placebo in HFrEF patients, cutting the combined rate by 8%. with omecamtiv mecarbil from 39.1%

FDA 52

FDA Documentation Labelling 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 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 111

Documentation FDA 111

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 83

Documentation FDA 83

ISPE

MARCH 8, 2023

To learn more about APQ Guides and other ISPE Guides, visit ISPE.org/publications/guidance-documents Learn More & Buy Meet the ISPE Staff: Tina Li In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. PE Magazine Wants You!

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Documentation Communication 52