ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Know the key topics.

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Pharmacy Is Right For Me

APRIL 4, 2023

Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC). It also improves care coordination and eliminates communication gaps. It involves the training of community paramedics in performing some aspects of medication reconciliation.

Hospitals 130

Hospitals Communication Medical Records Documentation 130

pharmaphorum

NOVEMBER 15, 2021

That’s why the GLSP document, which has been included in EudraLex Volume 10, is just as applicable in other markets, including the UK and US, as they are in the EU. “We The text, the structure of the text, and the presentation of data needs to account for a limited understanding.”.

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Documentation Communication Hospitals 97

The FDA Law Blog

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Two licensed pharmacists must directly communicate the transfer. By Larry K. The content and prescription information elements required by 21 C.F.R.

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The FDA Law Blog

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

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The FDA Law Blog

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission. There are drawbacks to the current communication channels: 1.)

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FDA Documentation Labelling Communication 57

Roots Analysis

AUGUST 9, 2023

Integrating advance tools and technologies with manufacturing execution system (MES) ensure smooth communication within different production process, enhance decision making capability of MES and also enhance risk prediction capabilities.

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Documentation Communication 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.

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Labelling FDA Communication Documentation 62

The FDA Law Blog

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video.

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FDA Communication Documentation 51

PQA

DECEMBER 1, 2023

In support of this goal, PQA has performed a review of its bylaws and proposes revisions which modernize and streamline this important governing document. If community pharmacists can easily collect these data, they can be an effective resource to promote clinical trial diversity. Each member organization has one vote.

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Community Pharmacies Documentation Communication 59

Hospital Pharmacy Europe

NOVEMBER 2, 2023

To support the documents, in spring 2024 the RPS will launch a Greener Pharmacy Toolkit, allowing pharmacies to self-accredit their sustainability status. The green guides, which have been developed through multi-stakeholder feedback, set out actions that pharmacy staff and settings can achieve to help the NHS meet its net zero targets.

Hospitals 52

Hospitals Community Pharmacies Documentation Communication 52

Pharma Marketing Network

OCTOBER 13, 2021

Senior Director and Head, Scientific Communications and Operations at Biohaven Pharmaceuticals, shared advice with conference attendees on how to Navigate Getting Noticed, Hired and Promoted in a Virtual World. “Do Over-Communicate. Senior Director and Head, Scientific Communications and Operations at Biohaven Pharmaceuticals.

Communication 98

Communication Documentation 98

Viseven

SEPTEMBER 6, 2024

Achieving effective communication between a healthcare specialist and a patient is impossible if data the healthcare provider relies on data that can be misunderstood, misinterpreted, and misused. If any piece of data is used after its documentation or creation, it’s crucial that it be attributed to the original source.

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Health and Personal Care Stores Documentation Data Entry Pharmaceutical Companies 52

The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. Several sections of the eSTAR templates have questions that walk through related guidance documents.

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Documentation Labelling Communication FDA 52

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

The FDA Law Blog

OCTOBER 31, 2022

FDA proposes that “modern mechanisms that support clear and consistent communication of device information could facilitate efficient device review activities” and notes that they “consistently observed the need for structured data.” Despite the limitations in testing, some of the findings were noteworthy. Key Performance Indicators.

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ISPE

DECEMBER 6, 2022

Value of getting more information and context outweighs the risk of potentially having a documented path without conclusion. The same holds for whether we are paper based or digital; we should understand that documentation, in any form, should be kept professional and on-topic. Can’t perfect what we present.

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Documentation Communication 52

pharmaphorum

NOVEMBER 20, 2020

Behind the Mask is a global research initiative to document health experiences during the COVID-19 pandemic and beyond. Havas Health & You (HH&Y) has launched the details of a long-term global research project, Behind the Mask, a longitudinal, multi-armed study that focuses on documenting the ongoing evolution of health and wellness.

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Documentation Communication Medication Delivery 52

PQA

MARCH 8, 2024

Offering Resources to Implement Point-of-Care Testing The National Community Pharmacists Association and National Alliance of State Pharmacy Associations have developed a new guidance document to help community pharmacy teams with their point-of-care testing services. "A prior to the PQA Leadership Summit.

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Community Pharmacies Specialty Pharmacies Independent Pharmacies Documentation 52

ISPE

NOVEMBER 28, 2022

The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Internal Communication. CAPA Effectiveness.

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Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JANUARY 26, 2021

The document has been developed by the Davos World Economic Forum (WEF) and the Lung Ambition Alliance, in collaboration with AstraZeneca. Patients need reassurance that lung cancer services are safe and there needs to be investment in COVID-19 free clinical spaces, backed with communication about how services are kept safe.

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Documentation Communication Vaccines 104

European Pharmaceutical Review

JULY 4, 2023

There are also numerous industry guidance documents for products manufactured for use in clinical trials and guidelines, some which are specific to advanced therapeutic drug products that must be consulted. Teams must also accept the variety of analytical procedures these regulatory agencies prefer.

Communication 98

Communication Chemotherapy Documentation Dosage 98

The Checkup by Singlecare

DECEMBER 1, 2022

Assessing and communicating the regulatory guidelines for medication approval. Compiling the documents needed to obtain authorization for a new drug or designate a new indication or formulation for a previously approved drug. Presenting documents to the appropriate regulatory agency and making changes as necessary .

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Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 98

pharmaphorum

FEBRUARY 22, 2022

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. Listen deeply, stay present and pay attention to the discussion – not an electronic device. As a participant, arrive on time, too.

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Communication Documentation 80

Pharma Marketing Network

OCTOBER 13, 2021

Senior Director and Head, Scientific Communications and Operations at Biohaven Pharmaceuticals, shared advice with conference attendees on how to Navigate Getting Noticed, Hired and Promoted in a Virtual World. “Do Over-Communicate. Senior Director and Head, Scientific Communications and Operations at Biohaven Pharmaceuticals.

Communication 52

Communication Documentation 52

Hospital Pharmacy Europe

JUNE 8, 2023

They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents. Nevertheless, it is incumbent on trialists to communicate such changes.

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Documentation Communication Patient Care Hospitals 52

IDStewardship

APRIL 13, 2023

An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here. Folks from these groups need to be presenting at the same meetings, sharing information, and aligning their work to maximize organizational efficiency.

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Hospitals Documentation Communication Patient Care 246

European Pharmaceutical Review

MARCH 12, 2024

Good documentation practices. Following good documentation practices (GDP) throughout all stages of data generation, collection, analysis and reporting is vital. This involves keeping accurate and up-to-date records, documenting any deviations and corrective actions, and providing sufficient training to employees on GDP standards.

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Documentation Data Entry Communication Compounding 98

ISPE

NOVEMBER 2, 2022

Highlights were presented about what to expect in 2023 from ISPE leadership and Board members, and recipients of the 2022 ISPE International Honor Awards were announced. ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics.

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Documentation Compounding Communication FDA 52

DiversifyRx

JULY 11, 2024

To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request. The 3Ts can be in any format (paper, pdf, email), provided the required contents are all present. What if I do not qualify for the exemption?

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Independent Pharmacies FDA Documentation CPhT 52

DiversifyRx

MARCH 16, 2023

Be Present : Give your full attention and effort to the meeting or topic at hand. Provide them with the Parking Lot document HERE to supercharge your action! You can get more from your team and help them feel fulfilled by increasing communication with them as a group and one-on-one.

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Customer Service Independent Pharmacies Documentation Communication 98

pharmaphorum

OCTOBER 4, 2022

4) intended for the purpose of enabling such HCPs to independently review the basis for such recommendations that such software presents, so that it is not the intent that such HCPs rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient (Criterion 4). Criterion 3.

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FDA Documentation Communication Labelling 103

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. What do you love about your job?

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Documentation Communication 52

The FDA Law Blog

MAY 11, 2023

In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” It’s important to note here that the Government’s brief was signed by both FDA and the USPTO.

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Labelling FDA Documentation Communication 70

European Pharmaceutical Review

NOVEMBER 24, 2022

Tackling pharmaceutical counterfeiting continues, therefore, to be a clear and present priority for manufacturers, healthcare authorities and law enforcement. One area in which the problem can be tackled effectively is product packaging. Several branded medicines are available that feature holograms on the packaging or in the blister pack.”

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Packaging Labelling Documentation Dosage 111

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. It supports the analysis of Industry 4.0 to Industry 4.0

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Packaging Documentation Communication Data Entry 52

The Happy PharmD

SEPTEMBER 15, 2024

This annual report presents insights gleaned from over 79,000 Well-Being Index assessments conducted in 2023, with a particular emphasis on the 2,584 assessments completed by pharmacists. The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue.

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Documentation Dosage Communication Insurance 52