CMC SPIN: Combination Products

CMC SPIN: Combination Products
TOPRA's Combination Products and CMC SPIN Groups are pleased to welcome you to this webinar and workshop on Combination Products,






Date: Tuesday 17 October 2023

Time: 13:00-15:00 GMT/14:00-16:00 CET

Some medicines are used in combination with an integral or co-packaged medical device. They are commonly called combination products and require a proper understanding of the nature of both. Examples of such products include prefilled inhalers or auto-injectors (e.g. insulin auto-injectors), drug coated devices (e.g. antibiotic coated hip implants or steroid coated pacemaker leads), transdermal patches, plastic syringes co-packaged with a drug or reusable pens for insulin cartridges to name a few. 

In practice successfully navigating the maze of both drug/ biological product and medical device regulations poses a serious challenge for pharmaceutical, biotech and medical device companies. The distinctiveness of the regulatory landscape adds an extra layer of complexity, making it problematic to merge both requirements.

To close this gap two TOPRA spins: CMC SPIN and COMBINATION PRODUCTS SPIN have joined forces to prepare a dedicated online workshop. In this two-hour webinar we will examine the regulatory pathways for combination products. To help you gain a more practical perspective we will illustrate the process presenting two case studies. 

Agenda:

Introduction to Combination Products 20 min
Quiz         10 min
Case study 1         30 min
Case study 2         30 min
Questions for panel         30 min
     

This course is presented by five industry experts:
• Christina Mørk Hansen (Ralex Consulting, Fredensborg, Denmark)
• Ludivine Petit (Life2Science, Liege, Belgium)
• Leyla Toksoy (Alexion Pharmaceuticals, US)
• Peninnah Wanjeri (Alexion Pharmaceuticals, US)
• Niall MacLoughlin (Project Consultant, ComboDevice Consulting, Basel, Switzerland)

Moderator:
• Sarah Fitzgerald (Alexion Pharmaceuticals, Dublin, Ireland)

Project lead:
• Michal Mista (Xyzum Regulatory, Athlone, Ireland)
 

Pricing

  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

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When
17/10/2023 13:00 - 15:00
Where
ONLINE
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