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).

Packaging 84

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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.

Documentation 86

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 86

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?

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59

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.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

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).

FDA 98

FDA Insurance Chemotherapy Documentation 98

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.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmacy Procurement 52

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.

Vaccines 96

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 96

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.

Documentation 52

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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.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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.

Pharmaceutical Companies 87

Pharmaceutical Companies Pharmaceutical Companies Documentation 87

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.

FDA 114

FDA Pharmaceutical Companies Pharmaceutical Companies Documentation 114

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.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

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.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

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.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

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.

Health and Personal Care Stores 40

Health and Personal Care Stores Scheduling Appointments Communication Documentation 40

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.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

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.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

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.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

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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