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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

The compounds require special handling due to their cytotoxicity in the NCEs and investigational new drug applications (INDs). It’s a collaborative approach from safety, engineering, toxicology, and operations to have the most robust potent compound safety. What training is required for employees to handle HPAPIs safely?

Safety 92
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Advancement through adversity: how Covid-driven innovations are becoming best practices for pharmacovigilance

Pharmaceutical Technology

Before drugs are authorised, evidence of their safety and efficacy is limited to results from clinical trials, so it is essential that pharmacovigilance continues after a therapy has been approved. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing.

Safety 52
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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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From Europe To The U.S.: A Medtech Executive’s Career Chronicle With Fred Colen

Evolve Your Success

with Fred Colen as he shares his transformation from an engineer to a MedTech executive. A Medtech Executive’s Career Chronicle With Fred Colen In this episode, we have with us another special guest. Do I want to be a medical doctor or an engineer? You’ve got to keep training it. Do I want to be an engineer?

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Medical Sales In Sterile Processing And Infection Prevention With Mark Copeland

Evolve Your Success

— Watch the episode here Listen to the podcast here Medical Sales In Sterile Processing And Infection Prevention With Mark Copeland We have with us another special guest and he goes by the name of Mark Copeland. They train you like crazy. It’s the best training. Patient safety is to do no harm. It is insane.

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Driving Provider Engagement in Value-Based Care

Clarify Health

” In my years, I’ve worked with providers since the early 1990s, and like Michelle, I’m actually a scientist by training, and I have never found a provider that was not looking for a way to take the best care of their patients. But at the same time, specialists especially are incredibly special, right? Michelle: Yeah.