ISPE

JULY 7, 2023

CoP Leader Profiles: Christian Wölbeling Trudy Patterson Fri, 07/07/2023 - 12:16 InTouch July / August 2023 CoP Leader Profiles: Christian Wölbeling Marcy Sanford 1 July 2023 Christian Wölbeling has been a member of ISPE for 25 years. He is currently co-leading the team working on an ISPE guidance document addressing Pharma 4.0™.

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ISPE

MAY 10, 2023

Developed by a multinational team of experts consisting of engineers, toxicologists, hygienists, and analysts from major pharmaceutical companies and suppliers, the guide aims to consolidate this widely dispersed knowledge base into one document.

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ISPE

SEPTEMBER 28, 2023

Navigating Life Sciences Construction in California Trudy Patterson Thu, 09/28/2023 - 11:40 iSpeak Blog iSpeak Navigating Life Sciences Construction in California Gul Dusi 28 September 2023 Few industries have as deep a footprint in California, USA as life sciences. billion a year.

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ISPE

NOVEMBER 28, 2022

The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Valid 18 November 2022 – 31 January 2023.

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ISPE

JULY 6, 2023

ICH Q13 and What Is Next for Continuous Manufacturing Trudy Patterson Thu, 07/06/2023 - 06:51 Features July / August 2023 ICH Q13 and What Is Next for Continuous Manufacturing Gabriella Dahlgren, PhD Douglas B. 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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European Pharmaceutical Review

JANUARY 13, 2025

5 However, the benefits are well documented. Environmental Sustainability of the Globalized Pharmaceutical Supply Chains: The Case of Tenofovir Disoproxil Fumarate. 2023; 11 (17), 6510-6522. 2023; 33:5. 2023; 33(1): 24. Internet] My Green Lab: San Francisco California. Cited 2024August]. Green Innovation.

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The People's Pharmacy

MAY 8, 2023

FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S.

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ISPE

NOVEMBER 1, 2022

All of this energy has been channeled by the International Board into a rewriting of the ISPE Strategic Plan for 2023–25 with a “more confident position: Shaping the Future of Pharma.”. President & CEO. Lachman Consultant Services. Next Slide ??. Michael Kopcha. Thomas Wozniewski. Robert Weker. Transforming Global Manufacturing and Supply.

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Viseven

DECEMBER 13, 2024

Data collection involved paper forms, diaries, and in-person interviews , which, while essential for documenting symptoms and outcomes, were prone to human error. Maintaining regulatory compliance required extensive documentation and oversight, while handling paper-based data was labor-intensive and prone to mismanagement.

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pharmaphorum

JANUARY 9, 2023

This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.

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ISPE

JULY 6, 2023

One of the most important components of SRM is the company’s risk appetite statement. This document is approved by the firm’s board of directors and sets the tone for risk-taking at the company by key risks and setting risk tolerances for how much risk the board is willing to take across all business activities. March 2023.

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ISPE

JULY 10, 2023

ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Trudy Patterson Mon, 07/10/2023 - 15:37 Technical July / August 2023 ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Martin Heitmann, FRM Stefan MÜNCH Brandi M. Published 6 February 2023. Pharmaceutical Engineering 43, no.

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ISPE

MARCH 16, 2023

We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products. During the 2023 ISPE Europe Annual Conference , you will have the opportunity to explore all these topics in details.

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ISPE

AUGUST 15, 2023

™ and Annex 1 Conference on 11-12 December 2023. ™ and Annex 1 Conference on 11-12 December 2023. This conference will host six tracks on two significant topics for the pharmaceutical industry: 1) Pharma 4.0™ How can hardware, software, and process understanding be combined to create good GMP validation documents?

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European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceutical companies. References European Commission, (26 April 2023). Euractiv (6 October 2023). Article 63 PGEU (2023).

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ISPE

MAY 9, 2023

CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. Regulatory agencies can learn from the transformative experience required by COVID-19 pandemic restrictions.

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European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

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ISPE

MARCH 7, 2023

Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Trudy Patterson Tue, 03/07/2023 - 09:14 Features March / April 2023 Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Guy Wingate, PhD Ylva Ek Patricia M. The risks are equally applicable to both privately owned and publicly traded companies.

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ISPE

JULY 5, 2023

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. 5 In addition, there are human elements to consider.

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Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. However, RSV has proven to be fully capable of undergoing mutations and viral escape when challenged with pharmaceuticals.

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ISPE

JULY 6, 2023

9 As such, major investment is warranted for pharmaceutical companies to fully capitalize on the benefits of CM, and they need to make the hard business choice of investing time and money—with added risk—to widen their manufacturing portfolio versus putting money in established technologies that have been profitable. Zydney, and J.

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ISPE

MARCH 7, 2023

A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceutical company with regard to quality. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Press Release.

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European Pharmaceutical Review

OCTOBER 3, 2024

While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe on 25 August 2023. Register your details to read more The post How ready are you?

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Pharmaceutical Technology

JUNE 8, 2023

Pfizer, in addition to promising carbon neutrality by the same date via a 46% reduction in direct emissions and 100% renewable electricity purchasing, says its North American operations will be entirely solar powered by the end of 2023. Figure 1: Social media posts from pharmaceutical firms mentioning “environment”.

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Pharmaceutical Technology

MAY 5, 2023

Today, software companies know there is a growing market to meet demand for supply chain visibility platforms. The question for pharmaceutical companies is how they can best deploy their data to make supply chains more efficient. Another important thing is that manual evaluations have been reduced to less than 0.5%

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ISPE

SEPTEMBER 10, 2023

An Evaluation of Postapproval CMC Change Timelines Trudy Patterson Sun, 09/10/2023 - 11:22 Features September / October 2023 An Evaluation of Postapproval CMC Change Timelines Rob Harris, PhD Meike Vanhooren Kara Follmann, PhD Beth Kendsersky Timothy J.N. WHO Expert Committee on Specifications for Pharmaceutical Preparations.”

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