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

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

pharmaphorum

JUNE 22, 2021

The UK’s Department of Health and Social Care has published a document setting out its strategy on handling patient data – and defending its plan to transfer millions of GP records into a centralised database. The post UK gov’t defends NHS data sharing plans in strategy document appeared first on.

Documentation 52

Documentation Health and Personal Care Stores Medical Records Communication 52

IDStewardship

DECEMBER 13, 2024

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

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Communication Medical Records Documentation 225

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

pharmaphorum

FEBRUARY 4, 2021

There needs to be widespread information available to the general public, training for professionals and patients and targeted communications to health and political institutions. Giuseppe Recchia, director of Tendenze Nuove and promoter of the project said several steps must be taken to integrate DTx into Italy’s healthcare system.

Documentation 139

Documentation Communication 139

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

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

Pharmaceutical Technology

MARCH 30, 2023

One route to more engaged patients is clear, accessible information – but clinical trial documentation is often highly technical and full of jargon. Plain language summaries simplify clinical trial documentation, using language that any non-expert could understand. And post-trial, this sentiment continues.

Documentation 99

Documentation Communication 99

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.

Omnicell 98

Omnicell Cerner Medication Dispensing Documentation 98

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.

Documentation 98

Documentation Communication Hospitals 98

Viseven

JUNE 18, 2025

Scientific communication : Drafting slide decks, scientific responses, medical information letters, and training content using generative models, ensuring scientific accuracy and compliance in messaging and content. Clinical trials One reason clinical trials fail is choosing the wrong patients.

Labelling 52

Labelling Communication Documentation Pharmaceutical Companies 52

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

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

pharmaphorum

AUGUST 19, 2021

The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. While the methods and approaches necessary to achieve these qualities will differ from trial to trial, their validity, said the document, is universal. Read the full document here.

Documentation 105

Documentation Communication 105

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.

Communication 105

Communication Documentation Hospitals 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.

Documentation 105

Documentation FDA Adverse Reactions Communication 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

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

MARCH 5, 2021

The Commission will also examine whether Teva may have launched a communication campaign to create a “false perception” about the health risks of prescribing generic competitors, aimed at healthcare professionals and hospitals.

Documentation 98

Documentation Communication Hospitals 98

ISPE

NOVEMBER 23, 2022

Continue active cooperation with strategic partners , encourage PIC/S membership and strengthen PIC/S communications and engagement. Build PIC/S operational capacity by securing new revenue streams, implementing fiscally sound financial plans and increase transparency to the PIC/S community.

Documentation 98

Documentation FDA Communication 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.,

Documentation 130

Documentation Communication 130

pharmaphorum

DECEMBER 8, 2022

She has until 3 March next year to submit documentation to the appeals court, ahead of the scheduled start of her prison sentence on 27 April. They also used direct communication, marketing materials, media and financial statements, models and other information to defraud potential investors, according to the complaint.

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Documentation Communication 111

PharmD Live

MAY 13, 2025

Unlike traditional fee-for-service (FFS) models that incentivize volume, APCM promotes proactive, longitudinal care rooted in coordination, communication, and continuity. These codesG0556, G0557, and G0558are billable once per patient per month, provided all documentation and service requirements are met.

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Documentation Communication Hospitals Medical Records 59

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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FDA Documentation Communication 105

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. The following Guidance documents are critical to understanding the FDA’s policy for software products: Changes to Existing Medical Software Policies.

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Documentation FDA Communication 23

ISPE

FEBRUARY 1, 2023

This shift in approach to validation aims to realign effort to planning and preparation first, then defining the testing to be performed, and finally test execution and documentation. You may unsubscribe from these ISPE communications at any time. Download this whitepaper for a detailed approach to a successful transition to CSA.

Documentation 98

Documentation Communication 98

pharmaphorum

OCTOBER 4, 2022

Such non-device CDS are: (1) not intended to acquire, process, or analyse a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system (Criterion 1); (2) intended for the purpose of displaying, analysing, or printing medical information about a patient or other medical information (e.g.

FDA 105

FDA Documentation Labelling Communication 105

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.

FDA 59

FDA Documentation Labelling Communication 59

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

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 59

Documentation FDA Communication 59

The FDA Law Blog

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

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FDA Documentation Labelling Method Validation 71

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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FDA Documentation Packaging Communication 75

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

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

pharmaphorum

SEPTEMBER 23, 2020

Mia Ekdahl, head of communications at the park, says: “Industries – certainly the ICT and mobility industries – are getting closer and closer to traditional life sciences, and now life science companies are waking up to a world in which they, to a certain extent, have been bypassed. “The For more information visit the Park’s website.

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Documentation Communication Hospitals 140

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.

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Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52