pharmaphorum

DECEMBER 13, 2022

This precipitated a shift from a centralised trial experience to a decentralised one, resulting in participants communicating electronically. Both the EMA and FDA have released draft guidance on the issue and are currently soliciting feedback. BYOD in clinical trials. Statistics show there are 6.5

Data Entry 57

Data Entry HIPAA Insurance Communication 57

European Pharmaceutical Review

MARCH 12, 2024

Ensuring data integrity in the life science industry is crucial for regulatory compliance. Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry.

Documentation 91

Documentation Data Entry Communication Compounding 91

Pharmaceutical Technology

MARCH 22, 2023

The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format. In August of 2022, Fresenius Kabi announced a three-year plan to add GS1 Data Matrix barcodes, also known as 2D barcodes, to its US pharmaceutical portfolio.

Labelling 105

Labelling Data Entry Communication FDA 105

ISPE

MAY 11, 2023

™ 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. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. initiatives. to Industry 4.0

Packaging 52

Packaging Documentation Communication Data Entry 52

pharmaphorum

DECEMBER 6, 2022

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. In most cases, the EHRs and EDCs don’t communicate, so in order to share that data with trial organisers, staff members at medical centres must manually copy data between the EHR and an EDC.

Data Entry 98

Data Entry Communication Hospitals Documentation 98