Digital Pharmacist

NOVEMBER 21, 2022

On October 7 th , 2022 the U.S. 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. Road Towards Approval.

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European Pharmaceutical Review

JUNE 27, 2022

A guidance document has been released to support these activities. The Kigali Summit on Malaria and NTDs , hosted by His Excellency (HE) Paul Kagame, President of the Republic of Rwanda, on Thursday 23 June 2022, gathered world leaders to commit to ending these devastating diseases by the end of 2030. — GSK (@GSK) June 23, 2022.

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pharmaphorum

NOVEMBER 15, 2021

Under the EU clinical trial regulations, explained EFPIA’s Science Policy and Regulatory Senior Manager Silvia Garcia, sponsors will be required to publish a lay summary of all trial results from February 2022. 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

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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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. 2021 [Cited 16 September 2022].

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Pharma Pathway

SEPTEMBER 19, 2022

Amneal Pharmaceuticals-Walk-In Interview for Sterile Manufacturing (Injectable/ Parenteral Unit) On 25th Sept’ 2022. Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in manufacturing area of injectable. Date: 25th Sept’ 2022. Job Description. Ltd, Plot No.

Documentation 40

Documentation Communication 40

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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Documentation Labelling Communication 105

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.

Documentation 105

Documentation Drug Development Communication 105

pharmaphorum

SEPTEMBER 16, 2021

The Royal Devon and Exeter NHS Trust has used electronic medical records to document and share medicines decisions with GP practices and community pharmacies. April 2022 is the start, not the end of the systematisation journey. Technology can also join up and improve services.

Biosimilars 113

Biosimilars Community Pharmacies Medical Records Documentation 113

FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

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European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 Eurostat (2022) “How many citizens had basic digital skills in 2021?”

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Packaging Documentation Communication Pharmaceutical Companies 98

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. Clarity in communication is not just about convenience; it is a fundamental aspect of ethical medical practice and research.

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Documentation Communication Mayo Clinic Drug Development 52

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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Documentation Labelling Communication 105

National Association of Boards of Pharmacy

JULY 22, 2022

Task forces and/or work groups will be used to conduct the reviews, with the ultimate goal of developing a set of recommendations that can be implemented and communicated by the boards of pharmacy and other stakeholders. Updates will be posted on the NABP website and other communications.

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Pharmacy Technician Communication Documentation Vaccines 52

Syner-G

MAY 4, 2022

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager. As highlighted in these guidance documents, the FDA offers five programs: fast track designation, breakthrough therapy designation, regenerative medicine advanced therapy (RMAT) designation, accelerated approval and priority review designation.

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Documentation Drug Development Communication 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

Documentation 52

Documentation Communication 52

pharmaphorum

SEPTEMBER 14, 2022

As will be discussed at the 2022 DPharm annual conference in Boston, IQVIA, a global clinical research organization, surveyed more than 6,400 participants across the U.S. So, it is critical that sponsors better promote DCT models and communicate the ease of the trial experience at every touchpoint when recruiting. Long-term partners.

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Vaccines Medical Records Documentation Communication 98

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Internet] Burak. cited 2023July]. Kartoglu U. Internet] WHO.

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Vaccines Communication Immunity Immunization 111

Flip the Pharmacy

MAY 5, 2022

Meanwhile, the pharmacist communicated with the patient's primary care provider on all of the previously mentioned findings. Collaborating with schools of pharmacy and meeting patients where they are in the community (i.e., senior centers) is another modality to providing high level care for our community members.

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Documentation Communication Diabetes 52

Putting Patients First Blog

FEBRUARY 5, 2024

In May 2022, the NHC relocated to a new, larger office space at 1730 M St NW, Suite 650, in Washington, DC. The NHC strives to share relevant policy work such as comment letters, working documents on policy positions, and white papers with its members well ahead of deadlines. To view our 2024 policy priorities, click here.

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Documentation Communication 59

Quality Matters

JUNE 21, 2023

In 2022 alone, six countries achieved ML3/ML4 for medicines and vaccines regulatory systems, leading to a call for increased adoption of risk-based approaches to post-marketing surveillance. Risk assessment, communication, and mitigation through post-marketing surveillance are also important steps in the process.

Communication 52

Communication Vaccines Documentation 52

Viseven

JULY 12, 2022

The Clinician of the Future 2022 report made by Ipsos reflects these significant changes: 86% of clinicians think that the rise of patients informed about their health conditions is a driving change in healthcare 90% of clinicians agree that quality measures, including patient satisfaction, have driven change in the industry in the last decade.

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Communication Documentation Hospitals 52

The Happy PharmD

SEPTEMBER 15, 2024

Based on the data, the average distress level among pharmacists has decreased compared to previous reports spanning from 2019 to 2022. The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. It has declined from 3.25 in 2019 to 2.59.

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Insurance Coverage and Processing Dosage Documentation Communication 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

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Packaging Documentation Labelling Communication 59

Putting Patients First Blog

SEPTEMBER 3, 2024

Furthermore, it is crucial to understand how patients perceive the communication and support they receive from health care providers regarding the management of their medications. Additionally, the NHC recommends including questions that explore how these access challenges were communicated and managed by health care providers.

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Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Putting Patients First Blog

JANUARY 10, 2024

Failure to Reconcile (FTR) Process: The NHC views the proposed changes to the FTR process positively as safeguarding consumers’ health coverage access, particularly for those with chronic conditions, by enhancing education, aligning with consumer protection principles, and ensuring clarity and accessibility in communication strategies.

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Insurance Coverage and Processing Communication Documentation Diabetes 40

Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program. Blendon, R., and Schnieder, E.

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Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Putting Patients First Blog

JULY 15, 2024

Engaging these communities in the policy development process ensures that their voices are heard and that their unique perspectives are incorporated into policy decisions. This includes obtaining informed consent, anonymizing data, and clearly communicating how the data will be used and protected.

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Health and Personal Care Stores Insurance Coverage and Processing Communication Documentation 52

Viseven

DECEMBER 13, 2024

RPA employs software robots, or bots, to carry out tasks such as data entry and extraction, insurance claims processing, insurance verification, payroll calculations, document verification, employee onboarding, and many others. According to McKinsley, 55% of patients are more satisfied with virtual visits than face-to-face appointments.

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Data Entry Hospitals Documentation Communication 52

Putting Patients First Blog

MARCH 13, 2023

We urge CMS to be as specific as possible about what information must be included in a notice of denial and that it must be specific, complete, actionable, and communicated to patients in plain language. We support efforts to assure that patients and providers have access to clear and actionable information about denials.

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HIPAA Hospitals Documentation Communication 40

Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. 10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes. He is reachable via e- mail at egascho@nhcouncil.org.

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Drug Pricing Drug Development Documentation Communication 40

The Thyroid Pharmacist

JUNE 14, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! Accessed June 9, 2022.

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Health and Personal Care Stores Immunity Immunization Documentation 111

ID Stewardship

APRIL 13, 2023

CMS regulations on antimicrobial stewardship for acute care ( QSO-22-20-Hospitals ) went into effect mid-2022. An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here.

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Hospitals Inpatient Documentation Communication 98

Putting Patients First Blog

NOVEMBER 14, 2023

15 The NHC advocates for rigorous, transparent documentation of the medical rationale in such instances to prevent discriminatory practices. This change also reflects the person-first language that is a current best practice in respectful and dignified communication. Section 84.4(e)

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Communication Hospitals Bioethics Documentation 40

Putting Patients First Blog

SEPTEMBER 26, 2024

Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. NHC comments on FDA diversity in clinical trials guidance. Williams, S.,

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Communication Clinical Pharmacology Documentation Drug Development 52

RX Note

FEBRUARY 23, 2023

Teaching - A selfless effort driven by passion Ideation - Dream big, start small Perspectives - How we viewed the world Work is Work - Do not take things too personal Knowledge is Not Free - The sad truth Communication - Food for thought Phone Addiction - Reflection on living Forget - Why I create notes?

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58