Just to add to what has been stated, In my opinion I would prefer a written agreement instead of verbal. I believe that whenever there is a mutual understanding of what is decided, then legal issues c...

It's also important to note that a NDA is a contract. And contract law is an entirely separate field from patent law. How contracts are interpreted is a matter of state law, and interpretations vary f...

In addition to what has been stated, I'd like to add: Neutral Evaluation In neutral evaluation, each party gets a chance to present the case to a neutral person called an "evaluator." The evaluator th...

Hello everyone, Although I understand Roberto's perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical compa...

I will have to agree as well. I would prefer the matrix organization as it also allows for greater flexibility in terms of outsourcing. In my experience, some projects that can be done outside the com...

In my current job, I work in a project based/matrix organization. Depending on the need, I am pulled into projects outside my direct functional therapeutic area as needed. I like the matrix structure ...

I agree that project teams should consist of representatives from each function in order to receive contribution from all roles. I have noticed in my experience, that having a mixture of people with v...

Very interesting article, Khemraj. I agree with you. Just to add it is very easy for risk managers to become occupationally tunnel-visioned. However, the job is to manage risk, not to avoid it unneces...

I like how you pointed out the importance of avoidance in high severity scenarios. It is also important to know in terms of cost, risk acceptance does not reduce any effects however it is still consid...

I agree with you Luisa, I'd also like to add that risk transference is the involvement of handing risk off to a willing third party. In my opinion, in the case of low severity I think it is a good ide...

Personally, I would hope the techs and surgeon's are aware of what is in the label (such as the risks) prior to using the product. Perhaps through training taken in advance. I agree , that in the sur...

Great post. Just to add onto what has been stated. Risk ranking and filtering is also particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed ...

I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of ...

Hi Grzegorz, it is true like you have said that design control is important in order to ensure quality and correct errors. It is also important to note that design controls are required for all Class ...

I agree that in certain instances, it could benefit the company to outsource the design transfer. For one thing, it is more cost effective. If the vendor follows all the specifications and is trained ...