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

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