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The GoCART Coalition: Guidance for pharmacists

Hospital Pharmacy Europe

8 The GoCART Coalition In 2020, the European Society of Blood and Marrow Transplantation and the European Hematology Association joined forces and launched GoCART – a multi-stakeholder coalition in the field of gene and cellular therapies manufactured from cells and tissues of haematopoietic origin.

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PAN-TB’s Phase II trials take a shot at shorter TB regimens

Pharmaceutical Technology

Earlier this month, the World Health Organisation (WHO) released a new guidance document with a strategic plan to counter TB on a national level. Sequella is a US-based pharmaceutical company that develops antibiotics to address drug resistant infections. GlobalData is the parent company of Pharmaceutical Technology.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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Three pillars of post-pandemic launch excellence

pharmaphorum

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

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Hidden compliance risks for life sciences companies

pharmaphorum

In 2020, life science firms accounted for a third of the SEC’s enforcement actions. Against this backdrop, it’s surprising that many life sciences companies — particularly small- to medium-sized ones — still don’t have a firm grip on their whole universe of partner risks.

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The NIH on accelerating research using diverse biomedical datasets

pharmaphorum

“For example, in early 2020, we enrolled somewhere between 3,000 to 3,500 participants each week. In March 2020, when the pandemic hit, we had to pause in-person recruitment. Martin is also the primary author of the pivotal FDA guidance document Collection of Race and Ethnicity Data in Clinical Trials. About the author.

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