Medicinal Products and Medical Devices - How to act on Combination Products

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The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

08.00 - 08.30 Welcome, Introduction, Presentation of the Speaker
08.30 - 10.00 Regulations and Requirements of Medicinal Products
  • Europe
  • FDA
  • Harmonised Requirements
10.00 - 11.00 Regulations and Requirements of Medical Devices
  • Europe
  • FDA
  • Harmonised Requirements
11.00 -11.15 Break
11.15 - 12.15 The new European Regulation
  • Content of the Regulation
  • How to apply the new Regulation
  • Differences to the European Directive
  • Adopting of the new requirements
12.15 - 13.15 Lunch

 

13.15 - 15.00 Combination Products
  • Definition of the Term
  • What regulations to apply
  • Differences in Europe and FDA
  • How to place the product on the market
  • Group Work on Combination Products
15.00 - 15.15 Break
15.15 - 16.30 Personnel Responsibilities
  • Responsibilities of the QP
  • Responsibilities of the person for regulatory compliance
16.30 - 17.00 CTD and TD in respect to Combination Products
  • Content of CTD
  • Content of TD
  • Harmonisation of the documents for combination products
17.00 - 17.30 Discussion

 

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