I’ve been involved in double blind and randomized studies. In the randomized study, we actually ran into an issue where the trial was cancelled. For t...

One example of what could shut down a clinical study is an adverse side effect, such as an allergic reaction. I’ve seen one clinical trial put on paus...

I’m not sure if clinical research would be the path for me either. I have some experience in creating clinical trial material and I did not enjoy it. ...

I’m not sure if cost would be the leading purpose for conducting a clinical study in a developing country but regulations and target audience would pr...

One example of this that I have heard about has been thalidomide. Thalidomide was used to treat nausea and morning sickness in pregnant women in the 1...

Great question- I would have to say that if I were a sponsor, I would not want to transfer the responsibilities of: selecting monitors & investiga...

From experience, I have seen GMP documents get updated fairly often and the reason for them being updated is usually because the previous instructions...

Great question, neb2. I’ve been a part of an internal audit once before and the main advantage that I saw as a result was that it introduced to every...

I think that the previous answers work to describe the idea of CAPA well. It’s basically saying that you will not make the same mistake twice. If you ...

That’s an interesting question. I think that companies everywhere would be extremely happy to save the money, time, and hassle of going through GMP pr...

To me, it would make sense to grandfather old documentation into the new system, as it is. In my previous experience when Quality Systems were changed...

From experience, I’ve found that GMP creates more arguments than anything else within a company and that is because of the ambiguity. The ambiguity le...

I agree with the above responses- R&D/Development phase seems to be the most expensive stage. The reason being that although one product may make ...

That’s a great question- I agree with your answer and thoughts on it. A big part of selling any item is the feel and confidence that you get when purc...

Hello, While all are extremely important, I have found that the most important thing for a product manager to know would be to stay informed about t...