I personally take women’s one day multivitamin as recommended by my doctor. During undergraduate years, I was going through extreme stress and anxiety with college courses as well as work life. This resulted in loss of appetite and dehydration and…   Read more»

My personal experience as a coordinator of a program at NJIT (non-medical). I would prefer a team who actually is passionate about the project. As a coordinator, I am responsible for 50 students and 6 tutors. My entire project depends…   Read more»

I have no experience in the industry, but based on what I know about ECO from Dr. Simon’s course, I would only use an ECO for profits. For example, if there is a major change that needs to occur in…   Read more»

Initiating a project idea is the hardest part of project development because if done incorrectly, your project will fail and you will waste time and money. So how would one avoid this? This is where business and market research play…   Read more»

My opinion applies to the business case especially coming from a family who owns and runs a business. A good project manager can run a business case based on his analytical skills and critical thinking. Before even getting to the…   Read more»

I agree with everyone. But looking at it from a different point of view.Cutting regulations will save more terminal patients however cutting down regulations can also be harmful for the long term. If a drug is approved based on minimal…   Read more»

Yes it is a living document and i agree with everyone here. However, you can’t look at this like a file on your laptop. These changes and processes actually cost money and time. When you are hired for a project,…   Read more»

It would depend on the client’s requirements. In many cases, the client may specifically require you to re-execute the entire verification and validation protocals. This can be costly but if the client does not receive the expected results, that would…   Read more»

Agreeing with everyone, yes both of the files are useful and in some instances as mentioned above, one file is more useful than other. But at the end of the day, both files are there for a reason. My personal…   Read more»

My understanding of it is, that it depends on case to case bases. It depends what your drug, device, or both intend on doing. Keep in mind, some risks may not appear in short term clinical trials. Or they may…   Read more»

I would like to share my interview experience on this post. I was interviewed for a position and the manager specifically asked me about GMP and what it meant. So in the real life examples, a company must be able…   Read more»

The Thalidomide disaster was talked about in my undergraduate organic chemistry course. It emphasis the interpretation of new discoveries and most importantly allows us to see that not every new discovery works the way we see it at first. This…   Read more»

I personally do not have any experience working in any industry. But from my understanding, I would imagine the company I work for would have either fall under FDA or EU. So under EU, the notified bodies will be filing…   Read more»

As far as my understanding, Guidance documents are not mandatory but it a template for reading directives. Guidance documents in EU, I would rank NB-MED higher than any other because it is written by the notified bodies which is the…   Read more»

It is easier to get devices approved in the EU because it requires less data and evidence compared to FDA. For example, FDA would require an actual study based on a big sample where in EU, you may be able…   Read more»