11 - 12 November, 2020
Online Event
Conference Day 1
11:45 am - 11:50 am
Pharma IQ Welcome
11:50 am - 12:00 pm
Chairman's Opening Remarks
12:00 pm - 12:40 pm
Nomenclature and device registration – where are we now?
Mark Wasmuth -
CEO,
GMDN
- Where are we in achieving our aims of global harmonization?
- What we have learned from the US UDI Rule, what does the future look like across European markets and how do we comply with the new UK requirements?
- Moving from process to analysis: what have we learned so far from some of the data? How are we seeing it being used and where are we seeing the value?
12:40 pm - 1:20 pm
Scan4Safety using UDI and Master Data in a Clinical Environment
Mark Songhurst -
Project Manager - Scan4Safety,
Leeds Teaching Hospitals NHS Trust
•Deep dive into the core enablers of Scan4Safety: GLN, GTIN, GSRN
•Learn about maximising the use of information, reviewing stock, decreasing holding, and increasing knowledge in inventory and product recall
•Explore other benefits including patient tracking, electronic patient record, full vein to vein blood transfusion, Advanced Therapy and CAR-T Tracking
•Discover how to prepare hospitals for the future: building a digital hospital at Leeds Teaching Hospitals
1:20 pm - 1:50 pm
Analysis of general UDI requirements and demonstration of the company-specific implementation procedure in a BI tool
Florian Haase -
Project Manager - UDI/EUDAMED & Operations Data Analytics,
Biotronik
- Discover UDI requirements and specifications from authorities and issuing entities to design efficient and generally applicable UDI processes
- Recognize the connections between the UDI implementation and overall UDI processes to pass audits easily and quickly
- Improve everyday UDI tasks such as decisions on UDI-DI triggers or the analysis of data elements
1:50 pm - 2:10 pm
Coffee Break
2:10 pm - 2:50 pm
Practical Usage of UDI on Software as a Medical Device
Laurent Van Linden -
QARA Manager Europe & International,
Agfa Healthcare
•Get to grips with good practice of labelling on software
•Discover how to handle legacy software products
•Case Study: How to tackle future updates or modifications to marketed products in relation to UDI
2:50 pm - 3:30 pm
Global Management Approach for Device Registration and UDI Data Reporting
Gary Saner -
Senior Manager, Information Solutions-Life Sciences,
Reed Tech
John Lorenc - Director Product Management – Medical Devices, Reed Tech
- Discover UDI policy, implementation, dataset, and submission differences between U.S., EU, China, South Korea, Saudi Arabia, and other regulatory bodies
- Learn lessons from FDA device registration and UDI data reporting to GUDID
- Determine your best global UDI data submission solution
3:30 pm - 4:10 pm
Main Challenges, Actions Taken and Lessons Learned as a Manufacturer, Importer and Distributor of Medical Devices Placed in the EU Market
Jorge Figueira -
QA Manager,
Pasante Healthcare Limited
•Compare EU UDI verification and validation, as well as risk management strategies
•Analyse EU UDI registration and CE certification processes
•Unpack EU UDI technical documentation and resource issues
•Scrutinise the opportunities for standardisation in the medical device sector on the use of UDIs
4:10 pm - 4:30 pm
Coffee Break
4:30 pm - 5:10 pm
Master Data Management Systems: Identifying the Right Solution for your Business
Dawn Fowler -
Director UDI and Master Data Management,
Masimo
•Explore internal vs. external solutions, including the advantages and disadvantages of each
•Delve into managing multiple data requirement types within MDM systems (regulatory and logistics), and discover what to include and what not to
•Discuss maintaining and implementing connectivity with unique global data repositories
5:10 pm - 5:50 pm
UDI Challenges for Consumer Healthcare Products
Alex Adams -
Global Regulatory Affairs UDI Lead,
Reckitt Benckiser
•Explore the challenges and implications of UDI for a Consumer Healthcare Company
•Consider the hurdles of a Global company with a very mixed portfolio
•Navigate Global UDI requirements where exemptions are key
