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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

Celadon was the first company to work through the ‘chicken and egg’ situation with the Home Office and MHRA in 2019-20, as we weren’t prepared to break the law to grow medicinal cannabis in order to gain GMP! How do you see the evolution of cannabis-based medicines, particularly when it comes to the ‘specials’ or fully licensed drug routes?

Medicine 132
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The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

2 In 2019, there were 7 potential family caregivers per older adult. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Sunny’s healthcare marketing agency, Xavier Creative House, specializes in pharmaceutical, biotech, and medical device.

Pharma 98
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Top Considerations for Data Protection and Cybersecurity within the Pharmaceutical Industry

Pharma Marketing Network

For companies that process “special categorizes of data, through research and clinical trials etc.,” The GDPR requires any company that processes large amounts of special categories of personal data to appoint a data protection officer , either by recruitment of a new employee or via an outsourced data protection officer.

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LAMP assays to enable rapid and sensitive detection of BCC

European Pharmaceutical Review

percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. As a result of the rate of contamination events, simple and rapid detection of BCC in non-sterile pharmaceutical products is critical to ensure consumer safety. l) within 30 minutes.

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Competition is on the horizon for costly narcolepsy treatments

pharmaphorum

In order to bring it to market, a special program called Risk Evaluation and Mitigation Strategy (REMS) had to be put in place, where only eligible patients could access the drug through a very strict process. Harmony Biosciences introduced Wakix to the market in 2019 as the first non-controlled substance for the treatment of narcolepsy.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59