EUCRAF Workshop Icon

Combination Products Workshop 2015

Preliminary Programme
Annual Meeting eucraf eucraf eucraf eucraf eucraf

Preliminary Programme

Regulatory requirements and development considerations for combination products of biologicals and devices

November 2015

Munich, Germany

Moderator: TBC

DAY 1

11.30 - 13.00 Registration and welcome snacks and refreshments
13.00 - 14.30 Workshop
14.30 - 15.00 Coffee break
15.00 - 17.30 Workshop
17.30 End of the day
18.00 Transfer to the venue of the social event
18.30 Social event

SESSION 1: Determining the development program of combination products of a biological and a device by the Target Product Profile

  • Examples of combination products of biologicals and devices
  • Classes of devices used in these combination products
  • Definition of the Target Product Profile (TPP) of the combination product
  • The combination product as life-cycle option for biological
  • Q & A / Discussion

SESSION 2: Regulatory pathways and requirements for combination products of a biological and a device

  • Regulatory requirements for approval of a combination product of a biological and device
  • Which guidance documents are available for the development of a combination product?
  • Is a CE mark or US 510(k) premarket notification required for the device and what are the regulatory pathways to get this?
  • Agency interactions during development of a combination product
  • The evolvement of data during development – what is required for earlier versus later clinical studies
  • EU and US regulators expectations
  • Q & A / Discussion

SESSION 3: CMC consideration for combination products of a biological and device

  • Selection of the device and considerations on the material, composition, manufacture, surface features to be considered for the combination with a biological
  • Set up of the consistent manufacture of the combination product in a GMP-compliant process
  • Investigation of the quality of the combination product – what needs to be tested for the combination in addition to the testing of the single components
  • Leachables, extractables, degradation products, impurities – what needs to be tested, and validated, how to set up the risk-evaluation approach to get the right data
  • Determination of the shelf-life of the combination product
  • Q & A / Discussion

DAY 2

08.30 - 09.00 Welcome Coffee
09.00 - 10.30 Workshop
10.30 - 11.00 Coffee break
11.00 - 13.00 Workshop
13.00 - 14.00 Lunch break
14.00 - 16.30 Workshop
16.30 End of the workshop

SESSION 4: Non-clinical development of a combination product of a biological and device

  • Options and needs for the non-clinical development program
  • Factors to be considered in the planning of safety, pharmacology and dose-determining studies
  • Case study on non-clinical package of a combination product of a biological and device
  • Q & A / Discussion

SESSION 5: Clinical development of a combination product of a biological and device

  • The clinical development plan for a combination product
  • Investigations for dose determination and adequate dose delivery
  • Data requirements for efficacy and safety of the combination product of a biological and device
  • Post-marketing surveillance of combination products
  • Q & A / Discussion

SESSION 6: The CTD for a combination product of a biological and device

  • Regulatory dossier requirements – where to put the information on the device and the combination product into the CTD
  • Planning for post approval commitments
  • Q & A / Discussion