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11-12th November 2020 | Online Event 

>> Download the full programme to see our line-up of expert speakers and topic sessions.

Join us to: 

• HEAR DIRECTLY FROM HEALTHCARE PROVIDERS: we are delighted to be joined by the NHS with case studies from Leeds Teaching Hospitals NHS Trust
• ENSURE YOU ARE REGULATORY COMPLIANT: Update your understanding of the global regulatory landscape, by benchmarking against competitors and hearing from standards agencies, including the FDA, GS1 and Pasante Healthcare
• GAIN PRACTICAL ADVICE FOR SUCCESSFUL IMPLEMENTATION: Benefit from the sharing of peer-proven success stories and the exchange of creative approaches, with case studies from BIOTRONIK, Agfa Healthcare, Reckitt Benckiser and Bayer among others

In this report they will discuss:

• What the successful realisation of these incoming global UDI regulations mean for healthcare
• The benefits hospitals and clinics can get from UDI's
• The practical challenges during UDI implementation 

Organisations of all sizes are recognising the critical role of data quality in information governance and stewardship driven by broader enterprise information management initiatives.

Pharma IQ surveyed leading industry professionals on their challenges and investment plans for building a master data management (MDM) strategy to enable global compliance. The results have been presented in the following infographic to ensure your data is consistent, secure and compliant.

Download the infographic now >>

Other key benefits of downloading the infographic:

• Analyse the industry’s main challenges and key solutions for developing a master data strategy
• Understand best practices for obtaining guidance on global regulatory requirements  
• Exploring the greatest area of opportunity for improvement across the healthcare ecosystem

While UDI (Unique Device Identification) regulations support patient care objectives, many hospitals don’t yet know how to implement this requirement, which can hinder the progression to track information of a specific product.

With a view to ensure hospitals are continuing to make headway to overcome these implementation roadblocks, Pharma IQ has created a guidebook of the collated lessons learned by hospitals during the implementation of UDIs for medical devices. The guidebook also analyses how the conduct of manufacturers and hospitals can be altered to optimise the rollout of a project and avoid incurring any detriment.

Download the guidebook now >>

Other key benefits of downloading the guidebook:

• Understand the benefits of UDIs for medical devices while meeting the regulatory expectation
• Explore the implementation roadblocks that hinder hospitals today
• Analyse how to enhance the success of the practical implementation of UDIs for medical devices and evade any threats to patient safety or waste in resources
  

As the date of application of the EU MDR remains May 26, 2020, the European Commission officially stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022.

Therefore is there any need to care about UDI for now anymore?

In the following article, Patrick Pfau, co-founder of p36 explains why UDI will still be necessary considering the requirements of EU MDR and how to overcome upcoming challenges related to UDI. 

With Europe facing rapidly-approaching new UDI regulations, plans need to be put in place now in order to meet the deadlines, but the requirements from authorities are not yet clear, therefore manufacturers are unable to commit to costly projects. The question on medical device manufacturers’ minds is – what can we safely be doing right now, to best set ourselves up for the upcoming regulations?

In light of this, Pharma IQ moderated a roundtable conversation between three UDI experts, Tommy Røsholt, Contracting Project Manager for UDI compliance at Oticon, Tom Jones, UDI Program Director for Johnson & Johnson Supply Chain, and Jenny Young, Contact Project Manager MDR at Convatec.

The European Commission recently announced a two-year delay for the launch of the new version of European Database on Medical Devices (EUDAMED) being built to support the European Medical Device Regulation (MDR) including the module that will hold unique device identifiers (UDIs) and other required data on medical devices.

In a healthcare purchasing news article, Karen Conway, Vice President, Healthcare Value, GHX, responds to the state of regulatory unreadiness by offering standard practice solutions to prepare for EUDAMED, and improve transparency and coordination of information regarding medical device availability in the EU market.

Download the full article now >> 

• Acsensia Diabetes Care
• Agfa
• Allergan
• Arthrex

Preview of job titles: 

• Analyst, Project Management 
• Assoc. Dir. Packaging Technology
• CEO
• Deputy Director Medical Device Vigilance, Global Pharmacovigilance
  

Ahead of this years European UDI forum, Dawn Fowler, Director of UDI and Master Data Management, Masimo and Pharma IQ wrote a report on data management and UDI’s.

In this report they will discuss:

• The transition from GUDID to EUDAMED for FDA-compliant manufacturers
• Building a robust UDI MDM infrastructure
• What are the next steps for this industry