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 paper work of a device, drug or any idea basically in the industry or outside, you survey the market and analyze your…[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 clinical data, it may save some terminal patients. However, this isn’t the ethically correct. This is why Good…[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, you are expected to meet the client’s requirements. Client’s don’t change their minds on a regular basis, because every change they want…[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 mean loss of money and future deals. So the best way to handle this situation would be to see if…[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 opinion, I rather have both files on hand. If you need a quick overview of a project, do you really want to read through an entire file?…[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 not be significant risk given the time frame to determine if they are significant. For example, they may not be considered significant risks…[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 to provide a chain of custody of each product or sample in their possession. I would argue that Traceability influences a project in the…[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 is the reason major testing of any new discovery must be tested with multiple mediums. The drug was…[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 the paperwork as they are experts and actually have power to inspect manufactures and audit the devices. They will be the best…[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 key component of the EU and it has the authority to inspect the devices and their findings carry a weight on passing…[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 to get it approved on pilot data. Other factors include that FDA is a directly under the government and in EU a private company is chosen and…[Read more]