The clinical research path I know would not be something for me. But I do see it to be a good learning experience and provide a great base knowledge in regards to clinical studies and how the whole do...

I agree with the statement above that the clinical trials may be conducted depending on partially where the disease may be more prominent but the secondary is also the cost. This cost can be whether t...

Both of the cases provided above are great representation of a clinical trial going wrong. Companies before reaching the clinical trial stage, they make sure the pre-clinical trials are successful and...

That is an interesting point to bring up. Within my current company, I have seen how teams are not allowed bring in more individuals even though the workload has increased. And it is unfortunate becau...

From my experience, I am actually working on a project that currently deals with both. Due to regulation change in Asia on how the packaging is labeled, we were able to create the new product to refle...

In this week’s lecture, Dr. Simon discussed about nonconforming product and how action must be taken to make sure the DMR requirements are met. In addition, any rework must be completed before releasi...

I agree that is a change in the quality system occurs, the projects would have to be evaluated and see if the change will completely change the parameters of the project or allow them to be grandfathe...

With the way the GMP requirements are set up, it seems that it is trying to make any start-up companies fail. But as mentioned above, the GMP have general requirements to allow any style of company wh...

That is great input to this discussion so far. To add to the idea, the GMP is definitely required to also ensure that the product being sold is consistent. If the documentation used to make the produc...

For the product life cycle, I do think that the introduction around the launch time frame can be very costly. At this point, the company places all the effort into the marketing and preparing for laun...

Gp232, I agree with your call out since sometimes people do use those roles interchangeably and they are actually different. Product Manager is keeping track of the product as it evolved from the deve...

I do agree that both of the interpersonal skill and business knowledge are important during negotiation. However, interpersonal skill should definitely weight more since that is the drive that provide...

I agree with the statements above. I have seen, similar to Michelle, how a product is placed in the development stages and had the approval of the company based on the market but towards the middle of...

I personally do not have a direct experience to link a product failure but there are some common reasons for the failure to occur. The device can experience some form of contamination whether it is fr...

I agree with the key aspect of the post-launch product management being having the correct sales team to help push the product into the market and be a helpful resource to better understanding the nat...