Hi Andrew, I have always used Guidance documents to get better clarification on what the regulation is actually looking for. More specifically, I hav...

Hi all, From my limited experience, it is indeed a lot easier to obtain EU approval prior to US approval. The main reason in my opinion is that in EU...

Hi All, I have to agree with most of you regarding 3D printed medical devices becoming a popular trend. I currently work in a pharmaceutical company ...

From a legal standpoint, a written agreement is far more better than an oral one. As others have mentioned, a written agreement can be easily defended...

Hello Roberto, The gift restrictions are established by the Sunshine Act that came into effect in 2010. I had to personally abide by the restrictions...

As I have mentioned in a different post. I work in a hybrid organization that utilizes Functional and Matrix organization. This hybrid type uses proje...

I believe that all the responses above have mentioned what are the best practices to form a good project team. from my personal experience. Most of th...

I believe that all the responses here are very valuable and they offer very good methodologies on how risks are identified. From my experience, Risk i...