Helping you navigate through the maze of drug and device development.
For smoother sailing with an IND, it can help to have a meeting with the FDA before the IND. But how do you do that and what do you need? Find out from Aleese Hopkins and Samira Shirwa.
When you have an anomalous lab result, you just might be in trouble. However, Chris Vessely can help you close the case of what went wrong, help you find a way to save the day, and help keep you from getting in trouble in the first place.
Security from cyberattack for medical devices is paramount. And the FDA wants you to have a plan for it. Becky Ditty and Donna-Bea Tillman tell you how to be prepared.
Guidance documents:
Changes are coming to regulatory submissions publishing and we talk about two of them, eCTD 4.0 and standardized data, with Ben Wimmer.
How prepared is your facility? Being prepared is crucial and in this episode Vince Narbut takes you through commercial readiness.
The ICH has released a guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument. We conclude our two-part discussion of why to do that and how to do that with Bruce Pearce.
The ICH has released a guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument. We begin our two-part discussion of why to do that and how to do that with Bruce Pearce.
How can your organization continue to know what it's doing after people move on? Institutional memory. We talk about it with Kerin Ablashi.
How well does it work and how can you illustrate that? Diana Colleluori explains potency assays and best practices with them.
HeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.
The regulatory agency doesn't get a lot of time with your IND submission. To figure out how to make the most of that time, we talk with Emily Noonan Place.
You may not have everything that you need when it comes to making a drug or device submission. How do you know? With a gap analysis. David Pepperl explains it in our conversation.
Using your own cells to help you heal isn't science fiction anymore. Robert Kutner takes us into the world of in vivo cell therapy.
Bringing a drug or device to market can be arduous. In this interview with Debra Barngrover of Biologics Consulting, we learn how a consultant can help bring your picture into focus. Guest: Debra Barngrover Host: James C. Taylor
A little bit about the show.
If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.
Ding dong! Join your culture consultants, Matt Rogers and Bowen Yang, on an unforgettable journey into the beating heart of CULTURE. Alongside sizzling special guests, they GET INTO the hottest pop-culture moments of the day and the formative cultural experiences that turned them into Culturistas. Produced by the Big Money Players Network and iHeartRadio.
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How do the smartest marketers and business entrepreneurs cut through the noise? And how do they manage to do it again and again? It's a combination of math—the strategy and analytics—and magic, the creative spark. Join iHeartMedia Chairman and CEO Bob Pittman as he analyzes the Math and Magic of marketing—sitting down with today's most gifted disruptors and compelling storytellers.
The World's Most Dangerous Morning Show, The Breakfast Club, With DJ Envy And Charlamagne Tha God!