One trend to be aware of on these forums is the asking of questions to the class and not giving your own answer or opinion on the matter. That is not something that takes thought or substantive const...

What company would you choose to analyze, alexandrabuga?

We will learn later than an IDE is required for any clinical trial that poses significant risk, and usually this means that if you change the standard of care for a patient in the clinical trial, it i...

So given the content for this week, let's think about this. Some of you are saying, and pointing out, that e-cigs are drug delivery devices rightfully regulated by the FDA. If this is a Class III de...

Right, so the underlying message there is that CRO's are businesses that want to maximize their turnover. The more studies they do, the more money they make. How is the situation different in a unive...

Some great points made above, yes. You see some of the pitfalls that have happened with favoring close connections over sound business decisions, but as some of you correctly point out, the sound bus...

That is an excellent point. What happens many times is the project is broken up into sections. There's a general product development project, and then several separate regulatory projects hooked ont...

Definitely a good question, especially since either scenario could occur in real life: you could be working on a remote team, or working in an office every day. In either case, you would need to be ...

I would like to thank everyone for the great feedback. It confirms for me that the reason why I made this course and the way in which I designed it are benefiting people. You were a good group. One ...

That's an interesting comment which got my attention because it is different from some of the others. What other names or verbiage in the description would make it more accurate? Tell me more.

Think about a medical device being used during a surgery. The surgeon is scrubbed in and working on the patient. The techs in the OR are following the surgeon's instructions to hand things over, rin...

Would you be able to share with us some of the differences you see between Medical Device and Pharma risk management structure and technique?

The last post here is the most accurate. Design Controls are not "needed" in the EU in the sense that they are not mandated by a regulatory body like they are in the US. Granted, it is still a good ...

As I may have mentioned in the lecture, the DDP for most companies is just a boiler plate document that gets filled in, and pretty much remains the same throughout the project. What I am trying to te...

Every single task from the moment a clinical trial is conceived to the moment it is submitted to the FDA with complete data as part of a larger submission may be handled by a company or a consultant. ...