Impact Pharmaceutical Services

SEPTEMBER 20, 2023

Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.

Documentation 40

Documentation Pharmaceutical Companies Pharmaceutical Companies Communication 40

Viseven

JULY 10, 2024

It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication. As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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 98

Documentation Communication Hospitals 98

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

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

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 105

Communication Documentation 105

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

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 111

FDA Communication Documentation 111

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

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

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.

Communication 225

Communication Medical Records Documentation 225

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.

Documentation 114

Documentation Communication Labelling Data Entry 114

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.

Documentation 97

Documentation Communication 97

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

Viseven

MARCH 11, 2025

Improve communication with your clients and achieve better customer engagement with our templates ! Effortless document copying with “Edit in eWizard” Our team ensured version accuracy for the localization copy with the MLR-approved content item.

Documentation 52

Documentation Communication 52

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 This should cover the entire process, “starting with the writing, the review of the document, and its dissemination”.

Documentation 98

Documentation Communication Hospitals 98

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. Digital Health Policy Navigator Tool.

Documentation 23

Documentation FDA Communication 23

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?

FDA 105

FDA Documentation Adverse Reactions Communication 105

pharmaphorum

NOVEMBER 15, 2021

The All-Party Parliamentary Group (APPG) document – entitled No One’s Listening and partnered with the Sickle Cell Society – found “serious care failings” in acute services and evidence of attitudes underpinned by racism in the care of people with SCD, a red blood cell disorder that mainly affects black people. .

Documentation 120

Documentation Communication Hospitals 120

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

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

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers.

FDA 105

FDA Documentation Labelling Communication 105

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

SEPTEMBER 2, 2022

CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals. We need to stop thinking of guidelines as flat, text documents resembling journal articles. This type of communication has not changed significantly in hundreds of years.

Hospitals 130

Hospitals Documentation Formulary Information Medication Guidelines 130

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

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

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

pharmaphorum

FEBRUARY 28, 2022

Eventually, the app will evolve to allow direct communication with healthcare professionals, acting as a repository for test results and documents, and a channel for receiving personalised advice on health and estimates of waiting times.

Documentation 115

Documentation Communication 115

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

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

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

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.

Documentation 111

Documentation Communication 111

European Pharmaceutical Review

NOVEMBER 9, 2022

Another factor in this enhanced adaptability is development of in-house expertise that enables more efficient interaction by simplifying communication channels. Technology transfer of the process from development to manufacturing involves generating a wide variety of documentation, data and training.

Vaccines 115

Vaccines Documentation Communication Hospitals 115

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

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

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

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