Pharma Compliance CEE,Radisson Blu Hotel, Istanbul Asia, Istanbul, Turkey
Compliance Strategy for Pharma - Pharma Compliance CEE

BMI System

Gold Sponsor

BMI SYSTEM is a software editor dedicated to regulatory compliance for the healthcare industry. The company has developed different solutions for the pharmaceutical industry, the medical device industry and the diagnostic industry; each of them tailored for the specific regulatory requirements of these sectors. BMI SYSTEM’s team is based on a mix of regulatory compliance experts and software architecture engineers, this combination allows for a very fast development of applications tailored to the latest local and global regulations. BMI SYSTEM has offices in Paris, London, Boston and Brussels in order to be the closest possible to their customers’ needs and to the different legal requirements in these countries. New regulatory frame: With the introduction of new extraterritorial laws in the healthcare industry (Sunshine Act, Bribery Act, EFPIA Code…) one could think that a global solution sharing the same validation processes in reporting for all affiliates is the right approach. However, local regulations and codes of practice (ABPI Code, Loi Xavier Bertrand...) still keep their specificities and complete different processes for validation. This is why it is important to configure solutions and compliance according to the regulatory processes and requirements in each country, but also to be able to centralize all this data in a common platform for a global approval and validation. It is a trend of harmonization rather than standardization. Global healthcare organizations are under great pressure to perform safely and cost-effectively their regulatory processes, but with fewer resources. The newly introduced requirements for public disclosure of relationships with third parties in most countries can be seen as a heavy burden for companies under an already heavy regulatory compliance, but this is an opportunity for most of them to integrate their compliance and transparency approach with their governance and risk management processes. BMI SYSTEM new solution: BMI SYSTEM, the leader in applications dedicated to the transparency for healthcare industry, offers a new application called NAYA GRC 2013 which will help pharmaceutical companies to turn these new integrated processes in a competitive advantage. This application supports the validation processes of all local affiliates and also ensures a more global compliance. BMI SYSTEM NAYA 2013 is an integrated, scalable and flexible regulatory platform that addresses the needs of large global pharmaceutical organizations but can also be tailored to the needs of smaller companies thanks to its unique way of developing that adapts the costs and development time to the size of the customer. With already a large panel of customers in the pharmaceutical and medical device industries, BMI SYSTEM is able to develop compliant applications for all size of companies in any regulatory environment. All the aspects of post MA are covered by several modules offering an easy, fast and user friendly solution for most activities needing a huge amount of paperwork and a high level of traceability.

sponsors
Gold Sponsor
BMI System at Pharma Compliance CEE
Silver Sponsor
Thomson Reuters Accelus at Pharma Compliance CEE