Cours et événements à venir
Update on GDPR for medical devices companies
This training – focused on the Life Sciences sector – will provide an update on the most recent trends, guidelines, and recommendations since the adoption of the GDPR. It will also cover the relevant provisions under the Belgian Act of 30 July 2018 implementing the GDPR.
The training will finally address some data privacy challenges when using new technologies, such as blockchain.
Distribution of medical devices under the MDR
The training will identify the changes brought by the MDR, focusing on the independent obligations of distributors but also how they relate to other economic operators for MDR compliance.
It will address the requirements imposed by the MDR both in the pre-marketing and the post-marketing phases and is primarily intended for all economic operators distributing medical devices in the European Union.
MDR for legal and contract teams + Claims & promotion
This training session is aimed at those in charge of legal affairs within medical devices companies.
It will provide an overview of manufacturers and distributors’ obligations and the main MDR provisions that may impact the day-to-day job of Legal professionals, including in relation to claims / promotion and contracts of different natures.
MD software qualification & regulation under the MDR
It is intended for software manufacturers – of all sizes – who would like to know more about their products status, how they qualify under the new MDR rules (is it a medical device or not?) and how they can be classified (in which class does it fall).
The training will also provide an overview of the main MDR changes and address a set of basic requirements regarding Medical Device Software beyond qualification and classification.
Medical Devices legislation (MDR & Belgian law)
Topics during this training
- Legislation & legislative procedures in Belgium - general introduction
- Specific Medical devices legislation (incl. Mdeon, betransparent.be, notified bodies, classification, notification, materiovigilance, healthcare agencies & institutions, European guidelines, upcoming legislation & ethics…)
- Practical tips & questions
Public Tenders- beginners course
This training will give an introduction into public procurement procedures in Belgium focused on the medical devices sector.
It will touch upon the applicable legislation and principles, the different actors, the key features of tendering and an overview of the different procedures possible.
This training will include a tender documents walkthrough by which the different documents in the tendering process are analyzed and discussed with practical recommendations.
It will address key elements such as technical minimum requirements, selection criteria, awarding criteria, offer deadlines, e-Procurement, ESPD and much more.
Public Tenders- Advanced course
This training will focus on the current practical problems in tender procedures for medical devices, as well as on recent developments and case law concerning, amongst others, technical minimum requirements, selection criteria and awarding criteria.
In particular, this training will address items such as FAMHP Circular 646 and anti-gift rules, samples, value-based procurement, improvement proposals, commercial secrecy, price revision and much more. It will also touch upon what to do after awarding, where to look in the awarding report and which options are available to challenge awarding decisions.
Health Economic Evaluations for medical devices companies