The number and technological complexity of innovative healthcare products using drugs and devices is increasing, as patients and economic circumstances demand more patient-friendly and effective treatments that can also be used in the community or home setting. This requires pharma professionals to familiarize themselves with regulatory requirements for medical devices which differ significantly from drugs.
1.) Understand differences between pharma and medical device law
2.) Explain the responsibilities of EMA, competent authorities and notified bodies
3.) Classification of medical devices and impact on data requirements
4.) Clinical data and evaluation according to MEDDEV 2.7.1
5.) Conformity assessment and CE-marking of medical devices
6.) Device & drug combination products
7.) Risk management and vigilance
8.) Revision of EU medical device law
1.) Free 1 hour one-on-one consultation with trainers to discuss your projects to first 5 registeredparticipants
2.) Handouts from all presentations
3.) Certificate of training with 6 credit points for continuous education by SwAPP
Who should attend:
Experienced professionals and newcomers in pharma and medtech industries, aiming to improve their understanding of and compliance with the current law and upcoming changes related to medical devices.