NEXT DATE:
Nov 27-28
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A 2-day practical & interactive training:

Combination Products Regulations
Drug and Device Combinations in the USA and EU

Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.

Agenda

Why you should attend:
Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions. Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.

DAY 1
9am - 5pm
  • Including an interactive group session reviewing individual expectations
  • During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities. Regulatory Requirements for: US and EU
  • Interfaces: Change Management
  • CTA applications
  • Annual reporting
  • Including a walkthrough of expected outcomes for all case study exercises
DAY 2
9am - 5pm
  • Combination product regulation and CTD dossier requirments: EU and US (A comparative review)
  • Examining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products
  • Annual reports
  • Case studies
  • Taking into account your product's combined components when addressing adverse event reporting
  • Documentation requirements for combination products EU
  • Documentation requirements for combination products US
  • Interfacing, development, quality, regulatory
  • Managing third parties and document control
  • Final Q&A & Summary of 'working smart' with Combination Products
This training has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
1 attendee: $ 1,695.00
5 attendees: $ 5,085.00 $ 8,475.00 You Save: $ 3,390.00 (40%)
10 attendees: $ 9,322.00 $ 16,950.00 You Save: $ 7,628.00 (45%)
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For further questions please contact us: +43 (0)1 890 57 14