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). Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Digital health technology. tools (DHTTs).

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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. Remote communications.

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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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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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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). doi:10.1016/j.ijpharm.2020.119297 Harris, D.

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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. It supports the analysis of Industry 4.0 initiatives.

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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!

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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. Nature Communications 12, no.

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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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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. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 Published 15 November 2021.

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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. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 Published 15 November 2021.

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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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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.

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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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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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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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ISPE

SEPTEMBER 10, 2023

In this article, we describe the assessment of lag time for global regulatory approvals of postapproval CMC changes for multiple products over a three-year period. Scope The scope of the assessment was for country approvals received in the calendar years 2018–2020. The proposals are consistent with WHO GRP.

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The Thyroid Pharmacist

FEBRUARY 10, 2023

In this article, you’ll learn: Common causes behind low libido (and how the thyroid can affect this) Why conventional approaches to low libido don’t typically work in those with Hashimoto’s Natural solutions to increase low libido in both men and women What is Libido, and What Can Affect It? There are many natural solutions.

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The Thyroid Pharmacist

JANUARY 20, 2023

For the purposes of this article, I’d love to do a deep-dive focus on adaptogenic herbs, as one way to increase our body’s resilience and lower the impact of all types of chronic stress. This article features a long list of adaptogens, each of which has fascinating and unique properties. percent of people with Graves’. [5]

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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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