ISPE

OCTOBER 28, 2022

Fri, 10/28/2022 - 10:39. November / December 2022. 1 November 2022. This artificial intelligence (AI) retrofit project was a unique approach to implementing AI technology in a pharmaceutical environment within three months. AI Retrofit: Tackling Challenges with Cutting-Edge Technologies.

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ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 16:20. November / December 2022. 1 November 2022. In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products.

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ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 16:20. 1 November 2022. In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. 12 (2022): 1125–1126. Trudy Patterson.

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ISPE

SEPTEMBER 11, 2023

Herein, DM refers to a manufacturing model in which many units or facilities are disseminated across different geographical areas 6 , 7 DM facilities may produce similar or identical products under a unified pharmaceutical quality system (PQS) or operate as independent units with different outputs. Journal of Pharmaceutical Sciences 111, no.

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ISPE

OCTOBER 28, 2022

2022 ISPE Biotechnology Conference: Ongoing Growth & Development. Fri, 10/28/2022 - 08:14. November / December 2022. 2022 ISPE Biotechnology Conference: Ongoing Growth & Development. 1 November 2022. Trudy Patterson. Susan Sandler. Highlights of the discussion follow. Collaboration.

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ISPE

NOVEMBER 10, 2022

Thu, 11/10/2022 - 14:00. November / December 2022. 10 November 2022. Pharmaceutical Engineering® recently spoke with Kawamata about his work. Why QbD and Digitalization Are Foundations for Cell Therapies. Trudy Patterson. Online Exclusives. David Margetts. FBRI at Kobe.He

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ISPE

MAY 11, 2023

Implementing and validating a new process, or maintaining the validation status during process changes, is a requirement of the pharmaceutical industry. Published 2022. Validation of AI-Based Information Systems for Sensitive Use Cases: Using an XAI Approach in Pharmaceutical Engineering.” 3–7 January 2022.

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ISPE

MARCH 6, 2023

Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. Sixth Assessment Report: Climate Change 2021: The Physical Science Basis.” Finalized 9 August 2021. C global warming scenario.

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ISPE

JULY 6, 2023

In recent years, global pharmaceutical supply chains, still based on traditional batch- and intermediates-based manufacturing, were overwhelmed by their own vulnerabilities and inefficiencies, and were stressed to the brink of failure as a result of the SARS-COV-2 pandemic. This is demonstrated by the rise from $1.05 billion US in 2021 to $1.9

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ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. This platform technology is being adopted by growing ranks of large pharmaceutical manufacturers via licensure and acquisitions and by dozens of innovators. Pharmaceutics 14, no. 2 (February 2022): 260. Trudy Patterson.

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ISPE

MARCH 15, 2023

Whitford Emily Heffernan, PE Aoife Kelly 1 March 2023 Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. Accessed 3 December 2022. 7 November 2022. www.weforum.org/agenda/2022/11/3-ways-healthcare-systems-carbon-footprint/ 5 European Commission.

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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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ISPE

OCTOBER 26, 2022

Wed, 10/26/2022 - 16:08. November / December 2022. 1 November 2022. ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints.

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ISPE

AUGUST 29, 2022

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. HC is expected to have full implementation of ICH Q12 by late 2022. Published November 2019.

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ISPE

MARCH 7, 2023

For decades, the pharmaceutical industry has worked to transform the lives of patients by researching, developing, and manufacturing medicines for a wide variety of common and rare diseases, something that will continue for many years to come. The exact data requirements are dependent on the pharmaceutical product. “The Key Data 2022.”

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ISPE

NOVEMBER 30, 2022

Wed, 11/30/2022 - 14:39. 30 November 2022. In the Verdantix Green Quadrant: Asset Performance Management Solutions 2022 Report 3. , details how a large multinational pharmaceutical company ensured security of supply by implementing a PPM program that eventually rolled out to 30 sites. Trudy Patterson. iSpeak Blog.

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ISPE

JANUARY 9, 2023

™ World” article published in the May–June 2022 issue of Pharmaceutical Engineering ® . requires a paradigm shift in the pharmaceutical industry. Pharmaceutical Engineering, no. 3, (May–June 2022). Pharmaceutical Engineering 39, no. 6 (November–December 2019). Sáez, and M.

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ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 10:14. November / December 2022. 1 November 2022. C sponsors currently address numerous emerging pharmaceutical entities, as well as manufacturing platforms, modes, and scale. DPS project experience, December 2011–August 2022. Published 13 May 2022. Stephen Judd.

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ISPE

JANUARY 10, 2023

With the endorsement of International Council for Harmonisation (ICH) Q12 in November 2019, 4 and its ongoing implementation in ICH member countries, applying this approach has the potential for use as a global regulatory strategy. Genetic Engineering & Biotechnology News 41, no. Published November 2019. 5 (2021): 60–62.

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