RAPS Regulatory Converence Europe 2020

  Agenda - Workshops

 
Room 1 Room 2 Room 3 Room 4 Room 5
UDI Workshop Software as a Medical Device Usage of standardised test methods to comply with the general safety and performance requirements 
 
Clinical studies in PMCF en PMPF IVDR Workshop
Coffee Break 
Workshop continued Workshop continued Workshop continued Pre-Conference Workshop Pre-Conference Workshop
Lunch
workshop continued
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workshop continued
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workshop continued
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workshop continued
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workshop continued
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Coffee Break 

   Agenda - Conference

 
 

Opening Plenary 
The Theater, Le Plaza, Brussels 
16h30-18h30 
Welcome Reception
18h30-20h00 

 
 
  Device 1 IVD Pharma Device 2

Block 1 
 

Vigilance & Trend Reporting  Implementing Practices to Comply with the In Vitro Diagnostics Regulation  Supporting Innovation Working with FDA: Process 
   
Block 2
 
Beyond the Corrigendum: Strategies for optimal use of MDR grace period Performance Evaluation Reports -- Planning and Preparation in Anticipation of IVDR Requirements  Orphan Drugs  Working with FDA: Regulatory 
  Networking Break & Exhibits
Block 3 
 
MDR: Lessons Learned  Give me Data - Challenges and Opportunities of Real-World Evidence  RNA-Based Therapeutics: Opportunities & Challenges  International Regulatory Landscape Changes 
  Lunch & Exhibits
Block 4 
 
MDR Technical Documentation  Conduct of an actual IVD study compared with provisions of ISO 20916:2019, the new standard for IVD clinical performance studies Regulatory Strategy for Gene Therapy: Challenges and Opportunities  International Regulatory Changes: Member States 
   
Block 5
 
Challenges and understanding of the Periodic Safety Update Report (PSUR)  Regulatory hurtles to overcome to introduce nanotechnology-based IVD and medical devices to the EU market, a Safe-N-Medtech concern.  From Product Information to Promotional Material  UDI/Labeling 
  Networking Break & Exhibits
Block 6 
 
Clinical evaluation: Clinical data versus non-clinical data; how to interpret Article 61.10  IVDR stakeholders panel debate  "Navigating the Future of Regulatory Affairs"  MDR Implementation: Economic Operator Requirements 
   
  Device 1 IVD Pharma Device 2
Block 7 
 
CERs  IVDR Regulatory Strategy Plan!!:
A proper Regulatory Strategy is KEY for IVD Manufacturers and Test-Labs with in house developed tests/LDTs.
Changing Pharmaceutical Regulatory Landscape in China and Asia SaMD/Cybersecurity 
   
Block 8
 
PMCF  European Union reference laboratory for IVD  Working with FDA  Combination Products 
  Networking Break & Exhibits
Block 9 
 
Sufficient Data  The WHO prequalification (PQ) program for IVD in the light of the IVDR  MA Lifecycle Management  Software as a Medical Device: Comparison between US & EU approaches 
  Lunch & Exhibits
Block 10
 
Clinical Investigation under MDR  Clinical Evidence for IVD in Preparation for IVDR Dealing with Regulatory Requirements  Impact of Notified Body representative technical documentation sampling -
it affects your MDR compliance workload
  Networking Break & Exhibits
Block 11 
 
Risk Management  Navigating the Pre-Market Approval Process for FDA  Regulatory Changes: Biosimilars & Companion Diagnostics  Innovators & Regulators: Time to Collaborate
 
Closing Comments and Farewell Cocktail: 16h00-16h30