When the price of non-compliance can run into the millions of dollars or even having the product withdrawn from market, it’s imperative that companies are prepared to meet the EU’s revised timetable. It will take an enterprise-wide, cross-functional program based around data standardization, master data management, data quality and information governance. Companies need to identify exactly where all the data resides and establish how that data can be extracted and made compliant.
As defined in the Directive 2001/83/EC, medicinal products can be marketed for use in combination with a medical device, usually to enable the delivery of the medicine. This session will focus on different elements for PMS implementation for Medical Devices and how ArisGlobal has been progressing for IDMP and EUDAMED UDI implementation.
The Participants will be able to identify solutions to challenges relevant to the medicinal products and scenarios with which they work on Combination Products. This knowledge and awareness will help them build efficient strategies for IDMP implementation for different types of Combination Products.
Learning Objectives:
The participants will understand the background and purpose of IDMP and UDI Regulatory requirements.
The participants will understand the importance of Medical Devices with respect to the Directive 2001/83/EC from IDMP perspective
The participants will understand the elements required from the perspective of Iteration 1 of the PMS implementation for Medical Devices
Participants understand the current state of play with the UDI and IDMP implementation from regulatory perspective for medicinal products along with Medical Devices in ArisGlobal.
