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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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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Putting Patients First Blog

JULY 1, 2024

General Comments: The NHC commends CMS for its efforts in revising the MPPP model documents to enhance clarity, accessibility, and beneficiary engagement. Additionally, to further enhance the effectiveness of the documents, we recommend the formal establishment of a feedback loop and periodic reviews.

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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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Eye on FDA

NOVEMBER 17, 2020

It would appear plausible based on the information gleaned from the data announcements that there could be a filing for an EUA very shortly which could in turn mean that limited vaccinations could start being administered very soon. And also how will those who do not vaccinate because of medical or religious reasons be considered?

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Communication Vaccines HIPAA Documentation 81

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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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

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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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

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. Does FDA know?

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Communication Documentation 89

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

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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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.

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Documentation Communication Hospitals 98

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

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. However, in contrast to DMCs, such an entity should remain blinded to efficacy data.

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Documentation Adverse Reactions Communication Drug Development 105

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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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.

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Hospitals Communication Medical Records Dosage 130

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. Provide health information.

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Communication Documentation Pharmacy Management Immunity 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.

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Documentation 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.”

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Communication Documentation Diabetes 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 Pharmaceutical Manufacturing Packaging Documentation 98

pharmaphorum

SEPTEMBER 6, 2021

Additionally, issues such as poor quality documentation due to template-based reporting, and incompatibilities between different systems have further caused headaches and increased inefficiencies. Blockchain-based electronic health records would give doctors and nurses control over the flow of information from a single, trusted platform.

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Medical Records Health and Personal Care Stores Data Entry Hospitals 145

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.

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Documentation Communication Hospitals 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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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. The most immediate concerns are ensuring the public has the information to allow people to spot the differences between COVID-19 and lung cancer, and which services to access.

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Documentation Communication Vaccines 105

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.

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Documentation Labelling Communication 105

FDA Law Blog: Biosimilars

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.

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Documentation Labelling Communication 59

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

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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Documentation Communication 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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Documentation Drug Development Communication 105

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

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

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

FDA Law Blog: Biosimilars

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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Documentation Packaging Communication Labelling 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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European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. These standardised documents provide meticulously curated and scientifically approved information. percent as EU average with some Member States as high as 25 percent).

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Packaging Documentation Communication Pharmaceutical Companies 98

Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). One of them was about the appropriate use of links.

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Communication Documentation Labelling Pharmaceutical Companies 52