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.”.

Documentation 98

Documentation Communication Hospitals 98

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.)

FDA 59

FDA Documentation Labelling Communication 59

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.

Community Pharmacies 59

Community Pharmacies Documentation Communication 59

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.

Documentation 52

Documentation Communication 52

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

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.

FDA 53

FDA Communication Documentation 53

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.

Community Pharmacies 52

Community Pharmacies Specialty Pharmacies Independent Pharmacies Documentation 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

pharmaphorum

DECEMBER 19, 2022

Colombo’s presentation was followed by the panel, ‘The future of European cancer control in a time of crisis’. There were communication and psychology problems, he explained, and documentation was scarce or missing. Fitzgerald believed the present moment is unique, demanding international collaboration.

Documentation 96

Documentation Hospitals Communication Vaccines 96

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.

Communication 52

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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FDA Documentation Communication 72

ISPE

NOVEMBER 3, 2022

He presented on “The Potential Impact of Global Convergence on the Availability of Cell and Gene Therapy.” Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. Director, Center for Biologics Evaluation and Research.

Communication 98

Communication FDA Documentation Vaccines 98

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.

Documentation 52

Documentation Communication 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.

Documentation 105

Documentation Communication Vaccines 105

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.

Documentation 52

Documentation Communication Medication Delivery 52

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 82

Communication Dosage Chemotherapy Documentation 82

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.

Communication 80

Communication Documentation 80

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.

Documentation 52

Documentation Communication Patient Care Hospitals 52

The deprescribing.org Blog

APRIL 14, 2021

Providing good clinical care can be challenging as community pharmacists often don’t have access to useful resources, such as electronic health records. Communicating with prescribers, typically located offsite, can also have its challenges. Document, document, document. Discharge medication reviews. v=0Gb7Zs4ndXU.

Community Pharmacies 52

Community Pharmacies Documentation Hospitals Communication 52

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.

Documentation 89

Documentation Data Entry Communication Compounding 89

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.

Hospitals 236

Hospitals Documentation Communication Patient Care 236

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

JANUARY 19, 2023

During the session, representatives from all regions of the globe presented examples of activities related to antimicrobial resistance and antimicrobial stewardship. A poster presented by Anja St Clair Jones 2 described how 42 multidisciplinary health care workers in Zambia had been had trained in AMS through one of these projects.

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 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.

Documentation 52

Documentation Compounding Communication FDA 52

ISPE

OCTOBER 28, 2022

Measures had been put in place to reduce the close contact of engineers during COVID-19 restrictions, including working from home, and this presented a unique set of challenges for those working in the sector. In these scenarios, the tester is present with the equipment and the reviewer is remote, either at work or at home. Advantages.

Communication 52

Communication Documentation FDA 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.

Customer Service 98

Customer Service Independent Pharmacies Documentation Communication 98

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.

Labelling 72

Labelling FDA Documentation Communication 72

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?

Documentation 52

Documentation Communication 52

The deprescribing.org Blog

FEBRUARY 17, 2021

Pam and Lisa: The authors presented a very thought-provoking case for the ‘pros’ and ‘cons’ of deprescribing during a hospital admission. The key is communicating properly with community colleagues. This helps alert everyone, including the community pharmacist, to the intended changes. All of these pieces help continuity.

Hospitals 52

Hospitals Documentation Communication Patient Care 52

pharmaphorum

FEBRUARY 11, 2021

In each location these regulations and codes of conduct present challenges and opportunities for companies when working together with patients as collaborators in the design and conduct of trials. It also means that patient input can be used to design trial materials and supplies, such as the tote bag used to carry blister packs, for example.

Communication 94

Communication Documentation Hospitals Vaccines 94

The FDA Law Blog

DECEMBER 12, 2022

It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop. Please check out FDA’s presentation on this very topic – Is My Product a Medical Device? See here for the slides, here for the recording of the presentation, and here for the transcript.).

Documentation 23

Documentation FDA Communication 23

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 percent as EU average with some Member States as high as 25 percent).

Packaging 84

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 84

The Checkup by Singlecare

OCTOBER 17, 2023

Although this infection has been documented with almost all antibiotics, the most frequent offenders include clindamycin , ampicillin, amoxicillin, and cephalosporins. Clindamycin is present in breast milk, so the decision to breastfeed will be determined by a doctor. Antibiotics can increase the risk of an infection called C.

Vaccines 52

Vaccines Dosage Documentation FDA 52

pharmaphorum

APRIL 8, 2021

When we can control the messages being sent from the brain to our organs we can prevent deterioration in our health,” explained co-founder Oliver Armitage in his presentation. But to defeat this virus and future pathogens, she said, we need to open communication channels between scientists in every country.

Vaccines 85

Vaccines Documentation Communication 85

Hospital Pharmacy Europe

JANUARY 11, 2024

A systems approach recognises the roles that all specialties play in patient care and encourages open communication that avoids practices that unnecessarily separate different aspects of the fluid management team into independent parts. This is defined as more than 6 L per patient stay and more than 0.6 L per bed occupying day.

Hospitals 105

Hospitals Patient Care Documentation Communication 105

pharmaphorum

OCTOBER 5, 2021

Firstly, there is an ever-present need to reduce healthcare costs. On the patient-facing side, you can adopt wearable, connected devices or ePRO strategies for remote patient monitoring, to ensure the treatment team has well-documented patient information between visits, or you can delve into digital therapeutics.

Hospitals 132

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 132

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.

Documentation 52

Documentation Labelling Communication FDA 52