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. billion in 2021. Remote communications. Apps for Clinical Communications. A Hospital in a Pocket.

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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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Viseven

SEPTEMBER 14, 2023

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Prior to e-procurement, GlaxoSmithKline (GSK) , a global pharma brand, used old school paper cataloguing and communications over the phone.

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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

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. National Academies Press, 2021. 120554 (1 June 2021). Eventually all CM technologies will graduate from the ETP. 18 Schenck, L.,

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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. 1 (2021):48. 6540 (2021):341–42. 1 (2021):7200.

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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.” Published 15 November 2021. 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

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021. 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

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ISPE

SEPTEMBER 12, 2022

And I'd like to make industry aware of a PIC/S document that's intended to guide inspectors on good data governance practices. Data integrity citations in fiscal year 2021 dropped significantly, and the lack of physical inspection is widely considered part of the reason. The draft was issued in December 2021. Alonza Cruse.

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ISPE

JANUARY 8, 2023

In this article, we elaborate on the benefits and requirements on xAI from a GxP point of view, along with the development and production process, with a focus on strategies to ensure that the intention of use is met and to manage risks for safety that arise from xAI itself. 21 April 2021. link] 5 a b US Food and Drug Administration.

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Viseven

JULY 12, 2022

These categories can include short articles about news and updates in your company (its services and products), research-based long reads, infographics about industry trends, and beyond. It can be case studies about clinical research, articles that contain statistics, interviews with clients (or patients), and beyond. Post regularly.

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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

MARCH 7, 2023

This article explores effective management and oversight processes for accelerated delivery of large-scale programs of work. 10 May 2021. Communicating keynote successes will help encourage engagement and support. Gerber, and K. link] 6 Financial Reporting Council. The UK Corporate Governance Code.” April 2016.

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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. 11 June 2021. 22 June 2023. EMA/321483/2020. 3 July 2020. www.pmda.go.jp/english/rs-sb-std/rs/0012.html

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ISPE

MARCH 7, 2023

This article reviews two case studies that cover sustainable pack types and extension of shelf life. 9 December 2021. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” The Global Use of Medicines 2022.” Dahlbo, and P.

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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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ISPE

MARCH 15, 2023

There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. 14–25 (November–December 2021). www.sciencedirect.com/science/article/pii/S0255270121004116 18 NHS.

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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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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. Published 2021. IPRP Strategic Vision 2018–2021. You may unsubscribe from these ISPE communications at any time. WHO Technical Report Series, No. Edwards, K.

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