Across the life sciences, Regulatory Affairs (RA) teams and their colleagues in Quality and Safety are stretched beyond their limits as already impossible demands on their time are compounded by rising health authority expectations.
In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Sonia A. Veluchamy, CEO and co-founder of Celegence, a company dedicated to improving patient outcomes through intelligent regulatory compliance.
For both pharma and medical device companies, time and bandwidth are the number one challenge RA professionals face, closely followed by costs and budgetary pressures (the latter being a more pronounced concern for medical device companies). And, as the medical device sector responds to rising demands internationally around device identification, traceability, safety, and surveillance – designed to reinforce product quality and safety – companies have a chance to expedite their preparations, by looking to the adjacent pharma industry for lessons still being learned.
Veluchamy dives into the details and explains what all these endeavours ultimately mean for patients.
You can listen to episode 173a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes, Spotify, Amazon Music, Podbean, and pretty much wherever you get your other podcasts!
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