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ISPE Represented at PIC/S 50th Anniversary Event

ISPE

ISPE Represented at PIC/S 50th Anniversary Event. ISPE Represented at PIC/S 50th Anniversary Event. Continue active cooperation with strategic partners , encourage PIC/S membership and strengthen PIC/S communications and engagement. Trudy Patterson. Wed, 11/23/2022 - 06:50. iSpeak Blog. 23 November 2022.

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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. The same cannot be said for online events.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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Vertical pharma: How sector convergence can erase digital health siloes

pharmaphorum

That’s according to the team at Sweden’s Sahlgrenska Science Park, who are getting ready to host a virtual event looking at how the specialisation of digital expertise is driving a trend of sector convergence that pharma is only just cottoning on to. Innovation versus regulation. For more information visit the Park’s website.

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Top tips for effective digital transformation and closed loop medicines management

Hospital Pharmacy Europe

S erious adverse drug events are unfortunately common in hospitals and can occur across all stages of the medication delivery process. Right documentation. Engage the multidisciplinary team Involve the entire multidisciplinary team and foster trust and enthusiasm through regular communication, team building and cheerleading.

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

The FDA Law Blog

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

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Implementing Cloud-Based Pharmaceutical Plant Management Software: Data Security Considerations

ISPE

In the event of inaccessibility, a business continuity plan should be in place including potential production risks and decision tree. Furthermore, there should be an evaluation of the cloud service provider to verify potential impact to product quality and/or data integrity in the event of inaccessibility.