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.

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Putting Patients First Blog

JULY 1, 2024

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

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GMPSOP

OCTOBER 16, 2022

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

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Syner-G

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.

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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.

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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.

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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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Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

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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.

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Express Pharma

AUGUST 23, 2023

Specifically, during the Delta wave, vaccination was 68 per cent effective at preventing infection in residents without a documented exposure but was just 26 per cent effective in residents with exposure to an infected cellmate, the researchers said.

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Eye on FDA

AUGUST 10, 2023

Every six months, we do a look-back to see what has changed in the way that FDA is communicating. And the increase in profile of Spanish releases would also be higher when there are fewer press releases if the number of bilingual communications remained the same. Overall, there have been shifts in the way the agency is communicating.

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PharmaState Academy

MARCH 6, 2024

CASE STUDY Enhancing Interpersonal Skills Effective Communication with Multidisciplinary Healthcare Teams Table of Contents Case Study Context and Background: In the dynamic landscape of pharmaceutical sales, effective communication with multidisciplinary healthcare teams is paramount. Their task?

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Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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FDA Law Blog: Biosimilars

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.

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Eye on FDA

NOVEMBER 17, 2020

Vaccination for COVID-19 not only requires business planning, but communications planning in support of the decisions. Related to both of these first two questions – what sort of documentation will be necessary for an individual – either employee or customer – to present evidence of inoculation?

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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.

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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.

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GMPSOP

AUGUST 10, 2023

Scope : This procedure applies to the training and development of all personnel within a GMP site including the documentation and retention of training records. Procedure Originator is responsible for determining who requires training on Document Change Notification (DCN). Annual refresher training shall be documented.

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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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Express Pharma

AUGUST 16, 2024

Dr Udaykumar Rakibe, Founder of PharmaMantra, presented on the practical applications of QRM, using real-world examples to explain risk assessment, control measures, and the importance of ongoing risk communication. He emphasised the role of detection in ensuring that substandard products do not reach patients.

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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”.

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Eye on FDA

OCTOBER 19, 2022

The emergence of pharma on TikTok signals another facet in the evolution of healthcare communications and a similar pattern. Communicators and marketers would love black and white answers about concrete platforms. And they believe that the principles laid out to date cover pretty much any communications platform.

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Express Pharma

SEPTEMBER 18, 2023

By leveraging our pioneering technology, we can draw attention to major healthcare challenges and demonstrate how the virtual world improves outcomes in real life,” said Victoire de Margerie, Vice President, Corporate Equity, Marketing & Communications, Dassault Systèmes.

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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. .

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FDA Law Blog: Biosimilars

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?

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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.”

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Pharma Pathway

JANUARY 24, 2023

Team Player and good Communications skills. Kindly Cary the below Documents: Updated Resume. •Experience in Characterization & Identification of Organic molecules using Spectroscopy techniques like NMR, IR, LCMS, HPLC. Positive and confident individual with strong work ethics. Ltd (Mallapur Unit), 2nd Floor, Plot No. Photocopy).

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RX Note

JULY 15, 2023

Introduction Medical/case note entries are legal documentation of all contributions made by healthcare providers in a patient's care. It facilitates effective communication among healthcare providers by enabling the sharing of concise, informative and auditable records.

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GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

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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.

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FDA Law Blog: Biosimilars

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.

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Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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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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FDA Law Blog: Biosimilars

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.

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Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

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PharmD Live

JANUARY 22, 2025

Tasks such as billing, coding and documentation consume valuable time and resources, pulling focus away from direct patient care. PharmD Live supports retention by: Improving communication to build trust. To stay viable, physicians must optimize revenue streams without compromising patient care.

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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.

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