European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

Adverse Reactions 74

Adverse Reactions Documentation Medical Schools Packaging 74

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 82

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 82

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 84

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 84

The People's Pharmacy

MAY 8, 2023

According to the ProPublica report: “The percentage of overseas manufacturers that hadn’t been inspected within five years, or which have never once been inspected, has grown from 30% in 2020 to more than 80% in 2022.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

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 91

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 91

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

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. doi:10.1016/j.ijpharm.2020.119297

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52