Pharmacy Times

JULY 18, 2025

Compliance with FDA guidelines, including documenting clinical differences and avoiding investigational GLP-1s, is essential for compounders. Even as I write this article, there is a breaking story of another round of such letters. It would also be expected that the reason would be documented in the patient’s chart.

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Compounding Compounding Pharmacies Documentation FDA 73

Viseven

JUNE 4, 2025

And patients gladly take the opportunity to access their online medical records — 54% reviewed their records at least three times during 2022 , compared to 38% in 2020. What’s great is that they let patients learn at their own pace, whether it’s by watching a video, reading an article, or even playing an interactive game.

Communication 52

Communication Health and Personal Care Stores HIPAA Medical Records 52

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

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IDStewardship

OCTOBER 28, 2022

In this article a PGY2 Infectious Diseases Pharmacy Resident discusses social media as a resource for pharmacy residency recruitment, providing insights for both programs and candidates. . Article Posted 28 October 2022. While I strongly recommend reading the article, below are a few of the key takeaways. Authored by: Hunter O.

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IDStewardship

DECEMBER 13, 2024

In this article an experienced antimicrobial stewardship pharmacist discusses lessons learned from navigating antimicrobial stewardship metrics. BCPS, BCIDP Article posted 13 December 2024 If you cannot measure it, you cannot determine if you have changedit. Disclaimer The views and opinions in this article are those of the author.

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pharmaphorum

JUNE 3, 2021

This article appears in our digital magazine Deep Dive: Market Access 2021. An earlier consultation that closed on 18 December 2020, covered methods. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too. Leela Barham takes stock.

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Documentation 98

pharmaphorum

JANUARY 28, 2022

But never mind, 2021 was a blockbuster even compared to 2020 or 2019, with many sources saying there was twice as much, or nearly twice as much money raised this past year compared with the year before. And exactly how much more was that than 2020? Startup Health had it at $44 billion, a true doubling from 2020. Was it $57.2

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Documentation 141

European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

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European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. This article primarily discusses Appendix D5 Testing of Computerized Systems and Appendix M12 Critical Thinking. The GAMP 5 Second Edition includes: Six completely new appendices.

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ISPE

SEPTEMBER 8, 2023

This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). This article outlines these initiatives. What do you love about your job?

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Documentation 91

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63. Article 63 EMA (29 January 2020). Article 63 Euractiv (26 September 2023). Article 63 PGEU (2023). European Commission (26 April 2023).

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Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

Hospital Pharmacy Europe

JUNE 8, 2023

In the absence of transparency, he felt that both the pre-publication reviewers and those reading the final published article would not be aware of any retrospective protocol modifications and thus be unable judge the reliability of the final results. Later work simply re-affirmed this finding.

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Documentation Communication Patient Care Hospitals 52

pharmaphorum

FEBRUARY 9, 2021

The DHSC has simplified these objectives in their first report on metrics in the scheme, published in July 2020, as: For patients : simplify, streamline and improve access, pricing, and uptake arrangements for cost effective medicines, and deliver faster adoption of most clinically and cost effective medicines. About the author.

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Documentation 87

pharmaphorum

DECEMBER 31, 2020

With the text of the 1,200-page document now available, it has been confirmed that there will be mutual recognition between the two parties, which means that inspections and certification of good manufacturing practice (GMP) facilities by the UK regulatory authority will be recognised by the EU, and vice versa.

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Documentation 52

Pharma Marketing Network

OCTOBER 13, 2021

Just a few weeks ago, August 3 rd marked Black Women’s Equal Pay Day, or the day Black women had to work into 2021 to catch up to what white, non-Hispanic men earned in 2020. Dr. Abbott suggests that you start a new weekly ritual: every Friday, take time to create an outline documenting all that you’ve accomplished that week.

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Communication Documentation 98

ISPE

SEPTEMBER 8, 2023

The document is based on a number of reports from the EU Commission and aims to ensure citizens’ trust in AI systems. AI Technical Documentation and GAMP ® 5 In GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) 2 , Article 11 1 describes the technical documentation needed.

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Documentation 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.

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European Pharmaceutical Review

JUNE 24, 2022

FDA briefing documents that address these reformulation strategies should include a description of the formulation design strategy that is employed to minimise the formation of NDSRIs in the drug product, including supporting manufacturing information and, at a minimum, three months of accelerated stability data demonstrating control of NDSRI.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

JANUARY 9, 2023

Hayes Marc Ramoneda Rueda 1 January 2023 In this article, potential Pharma 4.0™ This article is the second part of the “Reimagining CPV for a Pharma 4.0™ ™ World” article published in the May–June 2022 issue of Pharmaceutical Engineering ® . 1 In that article, the business requirements were analyzed. are discussed.

Documentation 52

Documentation Communication 52

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Many organizations already have documented process maps.

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ISPE

SEPTEMBER 11, 2023

This article provides background knowledge from literature and data from experiments to enhance the discussion. The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45

Documentation 52

Documentation FDA Packaging Communication 52

Pharma Marketing Network

OCTOBER 13, 2021

Just a few weeks ago, August 3 rd marked Black Women’s Equal Pay Day, or the day Black women had to work into 2021 to catch up to what white, non-Hispanic men earned in 2020. Dr. Abbott suggests that you start a new weekly ritual: every Friday, take time to create an outline documenting all that you’ve accomplished that week.

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Communication Documentation 52

The Checkup by Singlecare

DECEMBER 1, 2023

Benjamin Feingold presented a hypothesis at the annual meeting of the American Medical Association suggesting that hyperactivity in children could be linked to the consumption of artificial food coloring, according to an article published in the journal Neurotherapeutics. But his suggestions were dismissed.

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Labelling FDA Documentation 52

Pharmaceutical Technology

JUNE 22, 2023

According to the document, this scheme would instead harm patient access to drugs, which will take longer to turn generic. Årdal previously wrote about the voucher scheme in a February 2023 article published in The Lancet. Baraldi was one of the authors of The Lancet article alongside Årdal.

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Documentation Communication 52

Viseven

JULY 26, 2022

In this article, you’ll find more about mobile health app development, its enormous role in HCPs engagement, and the principal outcomes of including mHealth apps in your multichannel or omnichannel marketing strategy. Digital health app providers added over 90,000 new apps to app stores in 2020. billion in 2021.

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European Pharmaceutical Review

JANUARY 10, 2024

This article discusses the complexity of microbiome-based medicinal products and the novel challenges being encountered to characterise and measure this complexity in a robust manner as they progress through the different stages of clinical development that can delay the progress of products to the market. 2020 [cited 2023 Dec] 4;1–16.

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Immunization Documentation 52

ISPE

MAY 10, 2023

This article discusses the main SPuMoNI accomplishments. Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Horacio Gonzalez-Velez, Ph.D.

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Chemotherapy Documentation Dosage Labelling 52

ISPE

JULY 10, 2023

For the sake of readability, we will use it interchangeably for both interpretations throughout the article. Our article concludes with an outlook on how the use of LLMs may evolve, beyond the current hype. ChatGPT is commonly used to refer to the chatbot web interface, and the underlying model.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 8, 2023

This article describes the goal of the initiative, characterizes the anticipated challenges to innovation, summarizes the industry’s need to innovate, and discusses regulatory initiatives that are currently in progress, including learnings from the recent pandemic. EMA/321483/2020. 3 July 2020. 22 June 2023. www.ema.europa.eu/en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf

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FDA Documentation Dosage Communication 52

Pharma Marketing Network

APRIL 30, 2021

At the time of writing this article, a search of clinicaltrials.gov found as many as 1,066 active or completed studies that include wearable devices. The rising popularity of these consumer wearables has been paralleled by a sharp increase in the use of digital technologies, including wearables, in clinical trials.

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Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

ISPE

MARCH 7, 2023

This article reviews two case studies that cover sustainable pack types and extension of shelf life. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Journal of Validation Technology (26 January 2020). Press Release.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

IDStewardship

APRIL 13, 2023

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. Gauthier, Pharm.D.,

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52

IDStewardship

AUGUST 29, 2022

In this article, an antimicrobial stewardship pharmacists provides five tips for new pharmacists. Article Posted 1 September 2022. References (articles that I cited in my blog post). Authored By: Stephanie Hsieh, Pharm.D. SHsieh_rx on Twitter. Dr. Hsieh on Youtube. resources, beta-lactam allergy assessment, etc. References.

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The Thyroid Pharmacist

JUNE 16, 2023

pylori flare back in 2020. This article will explain how black seed oil, which has grown in popularity in the medical world, may be a game changer and get you one step closer to putting Hashimoto’s into remission. In this article, you will learn: What is black seed oil? Published 2020 May 18. Cochrane Database Syst Rev.

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