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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pharmaphorum

JANUARY 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Why you should attend: Be able to determine if Article 117 is applicable to your products. The global pre-filled syringes market was valued at $1139.6

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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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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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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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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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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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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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The People's Pharmacy

MAY 8, 2023

According to the ProPublica report: “The percentage of overseas manufacturers that hadn’t been inspected within five years, or which have never once been inspected, has grown from 30% in 2020 to more than 80% in 2022.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud.

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The Thyroid Pharmacist

JULY 14, 2023

In this article, you will learn about: How LLLT works Existing LLLT research Some uses and benefits of LLLT for thyroid health Laser therapy in clinical settings and LED devices for at-home use Can Thyroid Tissue Really Regenerate? I want to share some information about LLLT with you and discuss some interesting research.

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ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). However, in the context of this article, we propose three key criteria as part of due diligence activities to happen before DHT vendor qualification by a pharmaceutical organization.

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ISPE

NOVEMBER 3, 2022

Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. A 2020 pilot invited external authorities to participate and observe EMA procedures authorizing COVID-19 vaccines and therapeutics. 2022 ISPE Annual Meeting & Expo.

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ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). However, in the context of this article, we propose three key criteria as part of due diligence activities to happen before DHT vendor qualification by a pharmaceutical organization.

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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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pharmaphorum

JANUARY 9, 2023

This article is the first part of three and covers the first three of nine predictions, here focusing on global healthcare environmental challenges and what they mean for the pharmaceutical industry. For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented. References.

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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

JULY 29, 2022

I was inspired to write this blog after the September 2020 Cameron Peak fires in Colorado. In this article, you will learn: How we are exposed to unhealthy air quality, indoors and outdoors. This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. How airborne toxins can affect the thyroid.

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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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pharmaphorum

OCTOBER 4, 2022

In this article, Ben Hargreaves takes a look at the renewed effort to tackle deaths from cancer in the US through the Cancer Moonshot. The Biobank was launched in 2020, with an initial aim of enrolling at least 1,000 patients with locally advanced or metastatic solid tumours and haematologic malignancies undergoing standard of care therapy.

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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.

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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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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

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The Thyroid Pharmacist

JUNE 14, 2023

In honor of Father’s Day, I want to recirculate my original Men’s Health article — with some updates. This article is dedicated to all of the special men in your life. (I You may have seen this article last year, around this time — some things have changed! His wife had Hashimoto’s.)

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ISPE

JULY 5, 2023

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. International Journal of Pharmaceutics 581 (2020). Biotechnology Progress 2020, 36 (3). 5 (2020): 14–15. doi:10.1016/j.ijpharm.2020.119297

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The Thyroid Pharmacist

DECEMBER 7, 2022

In this article, you will learn: How your family is exposed to flame retardants. On a positive note (and why I wrote this article), there are ways to reduce the prevalence of these chemicals in your home and reduce the toxic load in your body. Read this article about NAC for more information about how it can support thyroid health. [32].

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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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ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. 3 (2020):e2970. 16 June 2020. 10 (2020):1861–75.

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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

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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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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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.,

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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.

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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.

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The Thyroid Pharmacist

DECEMBER 1, 2023

In this article, you’ll discover: The role of vitamin D within the body The link between vitamin D deficiency and thyroid conditions How to test for vitamin D deficiency Lifestyle tips and supplements to boost your vitamin D levels What is Vitamin D? Published 2020 Jan 6. Published 2020 Sep 4. Published 2020 Jan 6.

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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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ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. 12 (December 2020):2874–89. Published 18 August 2020. Fierce Pharma.

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). This article highlights the regulatory expectations of raw materials, the challenges of postapproval changes. and the impact on supply resiliency.

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