STAT

FEBRUARY 23, 2023

attorney general is specifically looking at “communications with AKF, documents relating to donations to the AKF, and communications with patients, providers, and insurers regarding the AKF.” DaVita disclosed the new “civil investigative demand” in its latest annual financial filing to investors.

Communication 95

Communication Insurance Documentation 95

STAT

MARCH 28, 2023

That’s the vision pitched by a spate of new startups and major tech companies like Microsoft, which one year ago spent over $19 billion to acquire Nuance Communications , the biggest in a crowded field of players using AI to automate medical note-taking.

Documentation 126

Documentation Communication Hospitals 126

The FDA Law Blog

JUNE 10, 2024

Below we highlight FDA’s views about best practices for BIMO inspection communications, handling requests for records, and inspection preparation and follow-up as outlined in the draft guidance. Communication Best Practices During a BIMO Inspection Provide timely and accurate responses to information requests.

FDA 109

FDA Communication Documentation 109

STAT

NOVEMBER 7, 2022

No need to bring a laptop to every patient visit, or spend hours afterward on documentation. The artificial intelligence system is a dream for many doctors: It records their conversations with patients and automatically transcribes the notes into their computer systems.

Documentation 97

Documentation Communication Hospitals 97

pharmaphorum

JANUARY 26, 2023

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. ” To help communicate the new guidance, the PMCPA is planning to run two webinars next month for companies and media organisations, on 9 February and 21 February.

Communication 104

Communication Documentation 104

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Documentation 98

Documentation Communication 98

Hospital Pharmacy Europe

MAY 16, 2023

Cardiac day ward pharmacists help to improve medication safety through reviews and communicating any treatment changes to primary care providers, a new study has concluded. However, limited evidence exists on the role and value of a cardiac day ward pharmacist. A key secondary outcome was the number of MRPs accepted and resolved.

Documentation 52

Documentation Communication Hospitals 52

Pharmaceutical Technology

MAY 18, 2023

The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. The EMA set up a task force in 2016 in light of issues concerning medicine availability and supply chain.

Communication 99

Communication Documentation Patient Care 99

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.

Communication 130

Communication Documentation Vaccines 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.

Documentation 105

Documentation Communication Labelling 105

Viseven

JULY 25, 2024

Compliance documentation Compliance documentation, such as pharma regulatory guidelines for audits and reviews, standard operating procedures, reports, and records, should also be verified by an MLR team. Just a small error could lead to many people adhering to compliance documentation and making the same mistake in their work.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

Omnicell

JANUARY 10, 2023

Interoperability shifts these behaviors, allowing nurses to: Locate alternative medication storage areas Remotely document waste Remotely queue medications for multiple patients so one can focus on other tasks After nurses review the MAR for available medications, they can communicate with the pharmacy through PowerChart.

Omnicell 98

Omnicell Cerner Medication Dispensing Documentation 98

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.

Insurance 52

Insurance Insurance Coverage Documentation Communication 52

indispensable health

AUGUST 18, 2023

Technology offers a lifeline by automating documentation, report generation, and data entry: A. Voice Recognition Technology: Dictating notes through voice recognition software expedites documentation, freeing nurses from typing and ensuring accurate records.

Data Entry 52

Data Entry Communication Patient Care Medication Dispensing 52

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

IDStewardship

OCTOBER 14, 2024

brief report, concise communication) will provide structure guidance (number of words, figures/tables, references allowed). Some AI websites to check out include Dall-E for images, ChatGPT or Google Gemini for text, Suno for music generation, Microsoft Copilot for document analysis, and Plus for presentations. Gauthier, Pharm.D.,

Documentation 130

Documentation Communication 130

The FDA Law Blog

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.

Controlled Substances 44

Controlled Substances Documentation Communication 44

European Pharmaceutical Review

OCTOBER 3, 2024

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Documentation 52

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.

Documentation 52

Documentation Communication 52

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

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 104

Documentation FDA Adverse Reactions Communication 104

Omnicell

SEPTEMBER 5, 2022

In today’s complicated world, where keeping in touch with your pharmacy customers is more challenging than ever, new patient communications and engagement tools are needed. scheduling for immunizations and point-of-care testing), and improve satisfaction and retention.

Omnicell 52

Omnicell Communication Documentation Immunization 52

DiversifyRx

OCTOBER 27, 2023

Pharmacists need to communicate with the prescribing physician, review the patient’s prescription history through the PMP (Prescription Monitoring Program), and document the conversation in the patient’s profile. Without proper documentation, it’s as if the conversation never happened.

Independent Pharmacies 52

Independent Pharmacies Controlled Substances Documentation Communication 52

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

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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Documentation Communication 97

ISPE

APRIL 19, 2023

An effective project manager understands the associated processes of the critical systems/equipment under test and is able to identify any issues/misalignments with expectations that may compromise the qualification performance of another system or equipment and communicate/correct them accordingly. For example: 1.

Documentation 52

Documentation Communication 52

European Pharmaceutical Review

SEPTEMBER 13, 2023

As small and medium-sized enterprises (SMEs) often face unfair competition when doing business in Europe, through the (SME) Relief Communication, the European Commission (EC) has proposed new measures to provide short-term relief, boost long-term competitiveness, and improve equality in the business environment across the Single Market in Europe.

Communication 96

Communication Documentation 96

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.

Documentation 40

Documentation Communication 40

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 62

Labelling FDA Communication Documentation 62

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 57

FDA Documentation Labelling Communication 57

Pharmaceutical Technology

SEPTEMBER 14, 2022

The list includes providers of various products and services, including: Commercialisation strategies Identification, engagements, and insights Launch planning and execution Digital marketing and insights Multichannel marketing strategy and execution Communication plan development Scientific communication Medical expert engagement and communication (..)

Communication 40

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 40

Omnicell

JANUARY 10, 2023

The Chief of Anesthesia is now aware of flaws in documentation and has an awareness of open transactions through enhanced data visibility. Team members on the diversion team regularly communicate with the pharmacy to further increase responsibility.

Omnicell 52

Omnicell Medication Dispensing CPhT Documentation 52

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.

Documentation 64

Documentation Communication 64

Pharmafile

MARCH 21, 2023

It appears that the FDA is inclined to support Biogen’s amyotrophic lateral sclerosis (ALS) drug, tofersen, with documents released on Monday stressing the need for “regulatory flexibility” when assessing treatments for life threatening diseases such as ALS. The agency does, however, recognise the lack of clinical trial evidence in this case.

FDA 59

FDA Documentation Communication 59

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 95

Communication Packaging Documentation Pharmaceutical Companies 95

DiversifyRx

AUGUST 23, 2024

This documentation is crucial for accurately identifying and justifying addbacks. Communicate with Stakeholders: Clearly communicate the rationale behind add-backs to potential buyers or investors. Justification of Add-backs: Each add-back must be well-documented and justifiable.

Independent Pharmacies 52

Independent Pharmacies Communication Documentation Insurance 52