ISPE

SEPTEMBER 8, 2023

The scope includes innovations in modalities, modes of delivery and administration of medicines, pharmaceutical manufacturing and analytical technology, and digital transformation. The survey launched in April 2023 and is still open ! The survey consists of three parts, with the option to respond to all or any of the parts.

FDA 52

FDA Dosage Documentation Communication 52

ISPE

MAY 9, 2023

Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence Trudy Patterson Tue, 05/09/2023 - 09:34 Features May / June 2023 Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence Scott Fotheringham, PhD 1 May 2023 North Carolina’s Research Triangle is the largest of its kind in the US.

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

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. Watson, PhD Melinda Imperati S. Postapproval CMC changes have several drivers.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

ISPE

MAY 10, 2023

SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies Trudy Patterson Wed, 05/10/2023 - 09:25 Features May / June 2023 SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies Mariola Mier David Cerrai, Ph.D. 1 Smart Pharmaceutical Manufacturing. Juan Miguel García-Gómez, Ph.D. Chis, Ph.D.

Dosage 52

Dosage Chemotherapy Documentation Labelling 52

ISPE

JUNE 1, 2023

Addressing Process Scale-up Concerns in Chemical and Pharmaceutical Manufacturing Trudy Patterson Thu, 06/01/2023 - 08:00 White Paper — Sponsored Content Addressing Process Scale-up Concerns in Chemical and Pharmaceutical Manufacturing 1 June 2023 With any successful manufacturing endeavor, eventually, demand will exceed manufacturing capabilities.

Communication 52

Communication 52

ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 9, 2023

Crouse-Feuerhelm sees the need to recruit from outside the region in pharmaceutical stronghold metropolitan areas like San Francisco, Philadelphia, New York City, Boston, Los Angeles, San Diego, DC, and Chicago to diversify the talent pool a necessity. Pharmaceutical/Biotech Man. Laboratory Services Medical Devices/Diagnostic Man.

Communication 52

Communication 52

ISPE

JANUARY 9, 2023

Trudy Patterson Mon, 01/09/2023 - 12:20 Features January / February 2023 Using Technology for Continuous Process Verification 4.0 Hayes Marc Ramoneda Rueda 1 January 2023 In this article, potential Pharma 4.0™ ™ World” article published in the May–June 2022 issue of Pharmaceutical Engineering ® .

Documentation 52

Documentation Communication 52

ISPE

MAY 10, 2023

Sanat’s organization oversees a complex and large network of manufacturing, commercialization, and distribution operations across four different platforms of pharmaceuticals, vaccines, biologics, and animal health with over 20,000 employees in over 22 countries.

Vaccines 52

Vaccines 52

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. In 2021, CONTINUUS Pharmaceuticals secured a$69.3

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JANUARY 9, 2023

Background and Drivers One of the reasons GAMP guidance has always been successful is that it has always sought to accurately reflect current, good IT and software engineering practices, based on input from experienced IT, automation, and software practitioners. 1 June 2021. link] 4 International Society for Pharmaceutical Engineering.

Documentation 52

Documentation FDA Communication 52

ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Features May / June 2023 A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” Brown Megan E.

Documentation 52

Documentation Dosage Packaging Communication 52

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.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

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. 10 May 2021. 1 United Nations. link] 6 Financial Reporting Council. April 2016.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Online Exclusives A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MAY 11, 2023

™ Roadmap Trudy Patterson Thu, 05/11/2023 - 13:25 Technical May / June 2023 Methodology to Define a Pharma 4.0™ ™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. Published June 2008.

Packaging 52

Packaging Documentation Communication Data Entry 52

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. Some of these are more stringent than ICH requirements (e.g.,

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 7, 2023

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. 4 , 5 Other challenges reflect the cautious nature of pharmaceutical manufacturing, like risk aversion and regulatory considerations.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

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. 8 (2022): 4715–4731.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

MAY 11, 2023

Enhanced Intervention Detection in Aseptic Fill Using AI/ML Trudy Patterson Thu, 05/11/2023 - 10:32 Technical May / June 2023 Enhanced Intervention Detection in Aseptic Fill Using AI/ML Michelle Vuolo Christoph Koeth Robert J. 1 To that end, the basic premise of Validation 4.0

Documentation 52

Documentation Labelling FDA 52

European Pharmaceutical Review

NOVEMBER 7, 2023

It has been more than three months since the Unified Patent Court (UPC) and the European patent with unitary effect (unitary patent) came into full force on 1 June 2023, adding a new layer of options to the existing European patent system of national courts and European patents. & Ors (CFI_17/2023) and (CFI_326/2023).

100

100

PharmaShots

APRIL 3, 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Date - Jan 04, 2023 Product – N/A The acquisition is completed from a shareholder group led by Nordic Capital, in an all-cash transaction valued at $2.8B per ADS up front & CVR of ~$2.50

FDA 40

FDA Compounding Hospitals Vaccines 40

Pharmaceutical Technology

JUNE 22, 2023

Presented as part of the EC’s long-awaited pharmaceutical reform in late April, the scheme aims to encourage the research of novel antimicrobials by creating a system of transferable exclusivity vouchers. The Council of the EU, one of the bloc’s legislative institutions, adopted the recommendation on 13 June.

Documentation 52

Documentation Communication 52