Viseven

JULY 25, 2024

Ensuring the accuracy and authenticity of all your content Every pharmaceutical or healthcare organization, company, or even small business that creates and publishes any type of content faces a huge responsibility: providing both healthcare professionals and patients with true information backed by facts, studies, and other evidence.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

indispensable health

AUGUST 18, 2023

Technology offers a lifeline by automating documentation, report generation, and data entry: A. Electronic Health Records (EHRs): Embracing EHRs allows nurses to access patient information swiftly, reducing the need for manual chart searches and paperwork.

Data Entry 52

Data Entry Communication Patient Care Medication Dispensing 52

The FDA Law Blog

JUNE 27, 2023

FDA now seeks comments on this very program to support its continued collection of information as required under the Paperwork Reduction Act. On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH.

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FDA Documentation Labelling Communication 57

IDStewardship

MAY 12, 2023

Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Establish an open line of communication with your residency program director Different strokes for different folks! Knowing how the RPD communicates is important.

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Communication Documentation Vaccines 130

The FDA Law Blog

MARCH 7, 2023

If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission.

Documentation 57

Documentation FDA Communication 57

Omnicell

JANUARY 10, 2023

Standardizing an interoperability solution that supports information exchange creates better medication management practices for nurses and improved patient engagement. The EHR-ADC interoperability automatically identifies variances between medications dispensed from the cabinet and those documented as being administered and drives action.

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Omnicell Cerner Medication Dispensing Documentation 98

IDStewardship

OCTOBER 14, 2024

brief report, concise communication) will provide structure guidance (number of words, figures/tables, references allowed). Do not have it write your content for you or put any protected health information in, but certainly you can use it as a tool within your process. Gauthier, Pharm.D.,

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Documentation Communication 130

IDStewardship

SEPTEMBER 2, 2022

In this article an expert in clinical information design provides his insights, discussing reasons why some guidelines do not get used along with solutions to these problems. CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals. BCPS, BCIDP.

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Hospitals Documentation Formulary Information Medication Guidelines 130

pharmaphorum

MAY 25, 2022

“Where it is impossible to restrict access to HCPs, due to the congress platform or equivalent, there must be a clear statement to the attendee that the materials/communication are designed and intended for HCPs only.”. Here, we take a look at the top five takeaways from the document: 1. The codes still apply. End of the host country.

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Documentation Communication Labelling 105

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. However, in contrast to DMCs, such an entity should remain blinded to efficacy data.

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Documentation FDA Adverse Reactions Communication 104

Hospital Pharmacy Europe

JANUARY 17, 2024

Doctors should inform male patients who are taking valproate about the possible risk and discuss the need to consider effective contraception, for both the patient and their female partner,’ the PRAC said. But this will not have ‘implications’ for the new strengthened safety rules coming in this month, according to the MHRA.

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Communication Documentation Hospitals 105

Board Vitals - Pharmacist

DECEMBER 1, 2023

Patient Communication Some call it creating “happy patients,” others want to improve “patient experience,” and yet others mention “patient satisfaction.” Regardless of the term you use, communicating with patients in order to improve their care, compliance, and satisfaction is a worthy goal. It’s much easier said than done.”

Communication 98

Communication Patient Care Documentation Insurance 98

The Checkup by Singlecare

APRIL 25, 2024

Submit documentation: Required medical justifications and supporting documents are sent to the insurer by the healthcare provider. Communicate with the patient: The patient can ask about the progress of the prior authorization. The insurance company will then have to review the documentation before they can approve it.

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Insurance Insurance Coverage Documentation Communication 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.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 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. The questions are generally targeted on determining what information needs to be included in the 510(k).

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Documentation Labelling Communication FDA 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health. Furthermore, digitisation has simplified the process of gaining information on the drugs being prescribed.

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Pharmaceutical Companies Pharmaceutical Companies Communication Documentation 52

The FDA Law Blog

JULY 7, 2024

However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements. To be sure, Table 2 provides a handy visual of the categories of LDTs, the timeline for phaseout, and the scope of enforcement discretion for each test category.

Labelling 62

Labelling FDA Communication Documentation 62

pharmaphorum

NOVEMBER 15, 2021

These must be submitted into the Clinical Trials Information System (CTIS), part of the EU Database, portal, no later than 12 months after the protocol-defined end of the study. The lay summary project, then, fulfils a “current and future need” to provide information in a “transparent, reliable, objective way”. Boosting engagement.

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Documentation Communication Hospitals 98

Pharmaceutical Technology

SEPTEMBER 14, 2022

The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision. Prospects of clinical dose companies in contract marketing.

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Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 40

ISPE

SEPTEMBER 14, 2022

introduces it thus: Critical thinking is the intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action. Wikipedia 2.

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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). This empowers care providers with critical patient information. It also improves care coordination and eliminates communication gaps.

Hospitals 130

Hospitals Communication Medical Records Documentation 130

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. Offer helpful solutions.

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Documentation Communication 52

The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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The FDA Law Blog

AUGUST 9, 2023

The content and prescription information elements required by 21 C.F.R. Two licensed pharmacists must directly communicate the transfer. The transferring or receiving pharmacist must ensure that the populated information is complete and accurate. (to be codified at 21 C.F.R. cannot be altered during the transmission.

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Controlled Substances Documentation Communication 52

Viseven

SEPTEMBER 6, 2024

It is a critical aspect of any organization, as data integrity makes data valuable, enables informed decision-making, and ensures adherence to life sciences and pharmaceutical regulations. Maintaining one is impossible without maintaining the other, and only if both are preserved can data be trusted and used to make informed decisions.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Data Entry Pharmaceutical Companies 52

Digital Pharmacist

NOVEMBER 21, 2022

b) Marketing and Communications Oversight. Medicare beneficiaries will be secured by CMS’s finalization of revisions to marketing and communications regulations that will guarantee they get accurate and understandable information about their coverage. Provide health information.

Communication 98

Communication Documentation Immunization Vaccines 98

The Physician Pharmacist

MAY 16, 2023

He explains that clinical informatics focuses on one-on-one interactions with patients and how to improve the user interface to make the documentation process more seamless. One of the most significant benefits is improved interoperability , which allows healthcare professionals to share patient information more easily.

Documentation 52

Documentation Patient Care Mayo Clinic Communication 52

pharmaphorum

OCTOBER 6, 2020

Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data.

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Documentation Communication Labelling Data Entry 114

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. A copy should also be shared with family members.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Communication Hospitals 52

Viseven

AUGUST 7, 2024

Medical writing refers to creating healthcare-related textual content that aims to improve doctor-patient communication and provide insights on industry topics. Medical writers must be outstanding communicators, capable of breaking down complex ideas for the public and healthcare professionals in a digestible way.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

IDStewardship

APRIL 13, 2023

PACCARB provides advice, information, and recommendations to the Health and Human Services Secretary (HHS) regarding programs and policies intended to support and evaluate the implementation of U.S. Today this Taskforce is known as The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, or PACCARB.

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Hospitals Documentation Communication Patient Care 246

ISPE

DECEMBER 6, 2022

The culture needs to instead shift to the risk/reward sectioning of information, where we look at the benefit of broad access to information against the threat of data theft, loss, or inappropriate use. Information in the wrong hands. Dead ended information not getting addressed. Perceived Risks. Actual Risks.

Documentation 52

Documentation Communication 52

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

The QA Consultant supported the product development program by review and approval of documents such as Quality Agreements, Master and Executed Batch Manufacturing records, batch related Change Controls, Deviations, Investigations, analytical data, Validation reports and Stability protocols.

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Documentation Communication 40

The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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FDA Labelling Documentation Communication 52

The FDA Law Blog

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. In doing so, we hope FDA will adopt an open mind when it comes to expanding the topics on which it will consider providing informal feedback.

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FDA Documentation Communication 44

pharmaphorum

OCTOBER 27, 2022

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

pharmaphorum

JANUARY 6, 2021

According to a tender document , the “extreme urgency brought about by the COVID-19 pandemic situation” justified the decision not to open up the contract to competition. The document added that the technical demands for the project mean that X-Labs is the only provider capable of fulfilling the contract.

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Documentation Communication 64