ISPE

SEPTEMBER 8, 2023

This article offers highlights from the discussion. A highlight of the session was the mutual praise from industry and regulators on how well the two parties worked together during the pandemic to bring vaccines and drugs to the patients in record time. Attendees were invited to submit questions to the FDA representatives.

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European Pharmaceutical Review

JANUARY 29, 2024

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. These changes are summarised in Table 1.

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ISPE

JUNE 27, 2023

Korakianiti also referred to first QIG Workshop held in early March 2023 at which case studies in continuous and decentralized manufacturing were presented and discussed. Conocchia explained that discussions were being held to extend the EU - US MRA to include veterinary products as well as vaccines and blood products.

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Communication FDA Vaccines 52

ISPE

NOVEMBER 3, 2022

Challenges of individualized therapies include manufacturing, nonclinical development, clinical development, and product access. He focused his remarks on manufacturing challenges. In appropriate situations, nonclinical data and manufacturing information from one product may be able to be leveraged to another, he said.

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European Pharmaceutical Review

FEBRUARY 23, 2023

Despite this overlap, this article addresses the main challenges for industry and firms, and those for pharmaceutical microbiologists, separately, focusing on some of the difficult and often overlooked hurdles relating to quality assurance (QA) and quality control (QC) of licensed and marketed pharmaceutical drug products.

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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.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP).

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Documentation FDA Packaging Communication 52