BMI SYSTEM was proud exhibitor during the International Compliance Congress, which took place in Brussels, Belgium, from 21st – 22nd October 2014.
As international compliance becomes more and more predominant amongst pharmaceutical companies all over the world, this event brought together the most advanced companies within this field.
By exhibiting and speaking at this congress, BMI SYSTEM met with clients, prospects and industry experts to discuss best practices and “actionable insights to mitigate risk and enhance global Compliance systems” (Source: International Compliance Congress).
Meet with customers & prospects
BMI SYSTEM’s primary objective is to continually improve and adapt its software through feedback from its customers. With approximately 100 delegates from all over Europe and the USA, the congress was a good opportunity to meet various clients and prospects.
Discuss current issues and challenges
BMI SYSTEM has always been innovating and developing new products adapted to the market’s evolutions and to the regulatory updates both at local and international levels.
The main theme at this congress was “Cross-Border” cooperation and Global Transparency. Indeed, international compliance has become a crucial issue as more and more countries adopt new rules and regulations or strengthen the existing ones to improve transparency between pharmaceuticals companies and HCPs and HCOs.
An update of the Transparency implementation by the EFPIA members was presented, showing that most of the countries have adapted a one-to-one implementation of the EFPIA disclosure template.
However because of some local requirements (including the need to get the consent of recipients) this implementation remains a country per country approach. Furthermore, there are still a lot of pending questions: where to disclose? How to get consent? How to manage the consent removal?
Increase international brand image in the Benelux region
This event was a good opportunity for BMI SYSTEM to increase its international brand image in the Benelux region where the company has been present for several years.
Most of the companies BMI SYSTEM met with had already heard of the company and its software.
Share compliance expertise
The BMI SYSTEM break out session on Day 1 was led by Mr Laurent Clerc, Regulatory affairs expert and co-founder and focused on the following theme: “Strategies to Implement Cross-Border Compliance, Transparency and Regulatory Specifications”.
His presentation highlighted the fact that when implementing a software to manage Transparency requirements at the European level there a 3 types of specifications to take into account:
• Specifications linked to the countries’ structure (language, currency, alphabet)
• Specifications linked to national laws (pre-approval processes, data privacy requirements, competition law)
• Specifications linked to the way to implement the EFPIA code by each EFPIA member
This workshop was very well attended by approximately 40 delegates.
Laurent Clerc is a Regulatory Affairs Expert at BMI SYSTEM. He holds a Master of Health Law, a Master of Quality Assurance and an Executive MBA. Co-founder of BMI SYSTEM, he has a professional background of more than 18 years serving the pharmaceutical industry and hospitals within consulting firms specialised in regulatory affairs.
About the International Compliance Congress
The congress focused on the following points:
• Advanced Compliance Issues in Commercial Activities
• Align Internal Teams through a Centralised Compliance Language
• The Evolving Role of the Medical Science Liaison (MSL)
• Strategies to Build an Effective Risk-Based Compliance Monitoring Programme
• Global Anti-Bribery and Corruption Compliance