Hi Silvia, this month you will be the interviewed of “TODAY WE MEET”, our monthly questions section dedicated to IBI employees and their main partners. To start, I’d say let’s do a brief introduction to get to know you better, you have the floor!

Hello everybody!! I’m Silvia, RA&Clinical Specialist.

I got a Master Degree in Medical Biotechnology and Molecular Medicine at Università degli Studi in Milan (Italy).

I started my working experience in IBI in 2013, therefore in almost 8 years I have seen its great evolution from a young start up to a strengthened company.

More specifically I had been working for 6 years in the commercial department as a product specialist. I learnt so much on customer management, and it was a positive experience. Furthermore, I appreciated the possibility to travel and to get in touch with a lot of people from different countries.

Now I have been working in the regulatory affairs department, and I’m in charge of three main tasks:

• product registrations management in order to be compliant with the relevant regulatory laws of different countries;
• post-market surveillance management;
• clinical affairs management.

You’ve been part of the IBI team for several years now, tell us from your perspective how the company has evolved from your arrival up to today.

During these years in IBI, I have seen a strong growth thanks to a great team effort and external challenges.

The biomedical market is increasingly competitive and requires a company quality standard higher and higher.

One of the best IBI’s skill to face off these challenges has been its ability of renewal itself thanks to its proactive team and approach.

Now the company is structured with specific skills and competences without forgetting the importance of team working.

Let’s focus now on your role, as a Clinical Specialist how do you ensure proper communication between clinical research and quality?

That’s a good question. In the last years the impact of clinical affairs management has been getting more and more crucial in the biomedical field. The requirements becoming increasingly strict with a higher request of clinical data quality. Indeed, this trend is going toward clinical trials management similar to pharmaceutical standards.

In order to guarantee a very high quality management is essential to work with a well-established system. Clinical studies are conducted following specific internation standards, implementing and following internally specific procedures and under a constant monitoring of the activities.

Among the various activities you perform, you are also responsible for managing the PMS (Post Market Surveillance) with what tools do you monitor the security of SmartBone after it has been placed on the market?

Post market surveillance is a wide process addressed to monitor products already released on the market. In order to be efficiency it has to be organized with a team approach and involving the other departments, in particular the commercial one.

The activities and tools used to save the information from the market are agreed with the other departments and include:

• the distribution of questionnaires across our customers network,
• the collection of feedbacks and complaints plus other activities focus on the clinical aspects and in particular: gathering of single clinical cases, conduction of clinical studies and scientific literature review.

As a final question, I ask you to tell me what it means to you to work for IBI?

Working in IBI is never boring, there are always new challenges. There are two main personal aspects that I consider while working: the product and the working environment.

SmartBone’s features and its technology are very interesting, and it inspires increasingly more in-depth analysis of its clinical applications.

Furthermore, the environment in IBI is very dynamic and friendly and allows a very professional growth.

One of the most important aspects is the chance to be very independent in your own work with a continuous team brainstorming approach.

We have come to the conclusion of the interview, thank you for making yourself available and sharing your experience in IBI, see you soon!

It was a pleasure!! Bye bye!!