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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European Pharmaceutical Review

OCTOBER 3, 2024

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.

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Viseven

JULY 10, 2024

As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences. It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication.

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Pharmaceutical Technology

JULY 12, 2022

In total, the frequency of sentences related to digitalization between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,091 sentences, eight (0.7%) referred to digitalization.

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Pharmaceutical Technology

JUNE 28, 2022

In total, the frequency of sentences related to robotics between April 2021 and March 2022 was as frequent as in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, six (0.4%) referred to robotics.

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Pharmaceutical Technology

AUGUST 9, 2022

In total, the frequency of sentences related to artificial intelligence between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.

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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. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceutical companies. Article 63 EMA (29 January 2020).

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pharmaphorum

MAY 26, 2022

Ukrainian pharmaceutical companies are struggling to perform their duties in pharmacovigilance as Russia launched a wide-scale war in Ukraine. Russia’s full-scale invasion of Ukraine has already affected the global pharmaceutical industry a lot. This platform made work easier for many pharmaceutical companies.

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European Pharmaceutical Review

SEPTEMBER 22, 2022

This article will explore the advantages of using HCs, as well as several considerations for their effective use, including scientific methodology and regulatory guidance. Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the United States and Asia.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical advertisements play a significant role in shaping the industry as a whole, influencing both consumer behavior and healthcare provider practices. For example, advertisements can increase demand for certain medications, leading to increased sales and profits for pharmaceutical companies. Steinman, M. Landefeld, C.

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ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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pharmaphorum

MAY 14, 2021

This article appears in our digital magazine, Deep Dive: Market Access 2021. Practically though, there are risks of additional processes and requirements (and expense) for pharmaceutical companies. NICE has a global reputation as a pioneering HTA – but is that influence at risk now that the UK has left the EU?

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Viseven

SEPTEMBER 6, 2024

Good record management practices, quality risk management, and robust compliance frameworks are standard procedures in industries like pharmaceuticals and life sciences. In our new article, you will learn more about data integrity in the pharmaceutical and life sciences industry and why maintaining it matters so much.

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Viseven

AUGUST 7, 2024

If you read this article, you probably dream of getting your foot in the door with medical writing. This allows pharmaceutical companies to maintain their brand voice and facilitates information sharing. While pharmaceutical companies need medical writing services, they do not usually hire these specialists directly.

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ISPE

JULY 6, 2023

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe.

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Pharma Marketing Network

APRIL 30, 2021

In a separate panel, Jenn Horonjeff, PhD, who is founder and CEO of Savvy Cooperative, stressed the importance of pharmaceutical companies engaging with those communities in culturally-sensitive ways.

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ISPE

MARCH 7, 2023

3 , 4 Most companies have some existing initiatives underway, but many do not yet have a fully comprehensive and integrated program. This article explores effective management and oversight processes for accelerated delivery of large-scale programs of work. that apply to the scope of activities undertaken by their organization.

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ISPE

JULY 10, 2023

For the sake of readability, we will use it interchangeably for both interpretations throughout the article. We transfer the capabilities of ChatGPT to specific use in context to the pharmaceutical value chain, and elaborate on the context of use in the regulated areas of pharma, considering ChatGPT and LLMs in general.

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Viseven

JULY 11, 2023

Throughout the years, Salesforce gained a reputation as a trusted advisor and partner among thousands of companies across the world’s fourteen largest industries, including life sciences and healthcare. Teams can store all critical documentation, access it anytime, and share it with researchers and other stakeholders.

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ISPE

MARCH 7, 2023

This article reviews two case studies that cover sustainable pack types and extension of shelf life. A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceutical company with regard to quality. Global regulators are assessing drug products for quality, efficacy, and safety.

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Viseven

DECEMBER 4, 2024

This article will discuss pharmaceutical validation, its benefits, types, and basic recommendations. Pharmaceutical validation involves evaluating each manufacturing stage to ensure that predefined standards are consistently met. It also requires documenting the entire process, from raw material sourcing to product launch.

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European Pharmaceutical Review

JULY 1, 2022

Although there are currently no set metrics or prescribed areas of focus, there are several key areas that pharmaceutical companies can pinpoint when measuring the S in ESG. For pharmaceutical companies, ensuring that human rights are protected by offering transparency and performing due diligence in global supply chains is key.

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The People's Pharmacy

MAY 8, 2023

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. The article by Sidney Lupkin was titled “Tainted Drugs: When Medicine Makes Patients Sicker.” Since the start of 2013, pharmaceutical companies based in the U.S. Here’s the kicker.

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ISPE

NOVEMBER 1, 2022

International convergence is another area in which the FDA is a participant, including in initiatives related to viral safety (ICH Q5A), CM (ICH Q13), quality risk management (QRM; ICH Q9), analytical procedure development (APD; ICH Q2/14), pharmaceutical product life-cycle management (ICH Q12), and common technical document (ICH M4Q).

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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.

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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. 2 , 3 Key differences between CM of pharmaceuticals versus other chemicals relate primarily to volume and runtime.

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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. Technologies allow pharmaceutical companies to collect and analyze a massive amount of data to ensure proper drug safety.

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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. Even if regulators agree, the risk of a delay is enough to break a business case.

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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. Consequently, comparing results across companies and through time will establish an increasingly robust perspective of trends in global approval durations.

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Viseven

SEPTEMBER 18, 2024

Cloud-based tools allowed pharma companies to capture and share clinical data between research teams both securely and quickly. In this article, we will explore the main use cases for cloud computing in pharmaceutical industry, its benefits, and the challenges that still need to be addressed.

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pharmaphorum

JULY 10, 2025

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