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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Communication Documentation 80

Pharmafile

APRIL 25, 2023

The National Institute for Health and Care Excellence (NICE) has submitted a Final Appraisal Document (FAD) for the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. read more

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Documentation Communication 59

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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Biosimilars Communication Labelling Documentation 49

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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Documentation Health and Personal Care Stores Medical Records Communication 52

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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Communication Vaccines HIPAA Documentation 81

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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Communication Documentation 105

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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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 Pharmaceutical Manufacturing Labelling 105

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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Communication Documentation 111

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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Documentation Pharmaceutical Companies Pharmaceutical Companies Communication 40

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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Documentation Communication 98

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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Documentation Data Entry Communication Packaging 40

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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Online Pharmacies Communication Documentation 99

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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Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

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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Vaccines Documentation Immunity Immunization 98

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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Documentation Communication 139

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

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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Communication Documentation 89

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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Communication Documentation Diabetes 98

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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Documentation Communication 111

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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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

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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Documentation Communication Vaccines 105

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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Documentation Communication 74

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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Documentation Communication Hospitals 120

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.

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Hospitals Communication Medical Records Dosage 130

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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Documentation Adverse Reactions Communication Drug Development 105

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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Documentation Communication 81

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 Pharmaceutical Manufacturing Packaging Documentation 98

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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Communication Documentation Labelling Pharmaceutical Companies 64

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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Documentation Communication Hospitals 98

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.

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Communication Documentation 98

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. Remind patient regarding preventive services and other communications.

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Communication Documentation Pharmacy Management Immunity 98

PharmaState Academy

MARCH 8, 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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Communication Documentation Hospitals 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.

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Communication Documentation 96

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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Documentation Communication 115

Express Pharma

DECEMBER 11, 2023

Proper documentation and effective data management were underscored as essential elements in building and sustaining a culture of quality and compliance within the industry. To overcome these hurdles, Dr Gupta advised leaders to collaborate closely with regulatory authorities and proactively address compliance issues.

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Packaging Communication Documentation 104

Pharma Pathway

FEBRUARY 14, 2023

Working: Corporate Office’ Secunderabad Department: Maintenance (Formulation) -Assistant Manager Qualification: Diploma / B.Tech Experience: 05-08 years (Pass Out: 2019 to 2022) Skills: OSD/ OLD-Manufacturing (Formulation), maintenance management, HVAC, Water System, EHS Knowledge, Air Compressor, Documentation, Vacuum pumps.

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Documentation Communication 64