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

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.

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Communication Documentation 246

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.

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Documentation Hospitals Communication 321

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?

Communication 52

Communication Documentation Hospitals 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 246

Documentation Communication Hospitals 246

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.

Biosimilars 62

Biosimilars Communication Labelling Documentation 62

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

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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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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Documentation Customer Service Health and Personal Care Stores Communication 59

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.

Vaccines 98

Vaccines Documentation Immunity Immunization 98

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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Documentation Communication 52

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

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

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

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GMPSOP

MARCH 25, 2024

Additional documents included each month. Category 1 Standard hardware components Standard hardware components should be documented, including manufacturer or supplier details and version numbers. Any hardware configuration should be defined in the design documentation and verified in the installation qualification stage.

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Documentation Packaging Communication Pharmaceutical Companies 59

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 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 109

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.

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Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 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.

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Online Pharmacies Communication Documentation 99

Express Pharma

JULY 9, 2024

We’ve updated our draft guidance to help further ensure the industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing,” said Robert M Califf, FDA Commissioner. The revised draft guidance is open for public comment for 60 days.

Communication 105

Communication Documentation 105

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed for effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

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Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

Documentation 52

Documentation Packaging Communication Customer Service 52

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.

Documentation 57

Documentation Communication 57

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

GMPSOP

JULY 23, 2023

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

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Documentation Method Validation Packaging Labelling 52

FDA Law Blog: Biosimilars

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 Pharmaceutical Manufacturing Communication 44

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?

Communication 81

Communication Vaccines HIPAA Documentation 81

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.

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Documentation Communication 59

GMPSOP

OCTOBER 26, 2022

According to cGMP, validation in pharmaceutical industry can be defined as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” Additional documents included each month.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

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?

Communication 52

Communication Documentation Hospitals 52

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 104

PharmaState Academy

MARCH 6, 2024

You foster an environment of open communication and collaboration, where every voice is heard and valued. Observations will focus on non-verbal cues, communication styles, and interpersonal dynamics between sales representatives and healthcare professionals.

Communication 52

Communication Documentation 52

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 Documentation Diabetes 98

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).

Documentation 81

Documentation Communication 81

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 Pharmaceutical Manufacturing 52

FDA Law Blog: Biosimilars

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.)

Documentation 57

Documentation Labelling Communication 57

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