Hey everyone! We’re back and we hope you didn’t miss us too much. In this episode, we’re diving right back in and talking about Medical Devices - what they are, how varied they can be, and how they’re regulated (in general terms!)

Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

References

https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices

https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents

https://www.fda.gov/media/82395/download

https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements

https://hollandhoudek.com/implants

In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about Anthrax, and Anthrax vaccines. Maybe you know as little about it as Debbie, or maybe you know loads, but as always, Elyse is going to guide us through this topic from her goblin corner!

Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

References

https://www.ncbi.nlm.nih.gov/books/NBK220522/

https://www.cdc.gov/anthrax/prevention/index.html

https://blogs.cdc.gov/niosh-science-blog/2022/04/21/welders-anthrax/

https://www.cnn.com/2024/05/05/us/how-it-really-happened-anthrax-attacks

https://pmc.ncbi.nlm.nih.gov/articles/PMC7993152/

https://journalofethics.ama-assn.org/article/informed-consent-military-anthrax-vaccination-case/2007-10

https://www.fbi.gov/history/famous-cases/amerithrax-or-anthrax-investigation

https://www.sciencedirect.com/science/article/abs/pii/S0264410X22010453

https://pmc.ncbi.nlm.nih.gov/articles/PMC6147967/

https://ajph.aphapublications.org/doi/full/10.2105/AJPH.92.5.715

https://clearinghouse.net/doc/40458/

https://web.archive.org/web/20171114165441/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474027.htm

https://web.archive.org/web/20171114200815/https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMRegulatoryScience/ucm391665.htm

https://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax

In this episode, we’re talking about Data Management because of a listener question - thanks very much Aswini! So, we get into the weeds about the data that is collected as part of a clinical trial and what is done with it - including what “data cleaning” really is!

Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/