Organizer: The Center for Professional Innovation & Education

Start: Wednesday, 18 October 2017 @ 09:00

End: Thursday, 19 October 2017 @ 17:00

Sponsors: The Center for Professional Innovation & Education

Contact: info@cfpie.com

Venue: The Berlin Hilton

City: Berlin

Country: Germany

Target audience:
  • Pharmaceutical
  • Medical Device
  • Biotech
Description:

The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.

The course will also provide the attendee with a thorough knowledge of the following topics:
•Overview of the different types of variations and the different procedures for a Marketing Authorizations in the EU
•The different types of variations (Type IA, Type IB, Type II)
•Variations involving product information
•How to deal with unclassified variations
•Line extensions
•Work-sharing

Event type:
  • Workshops and courses

Capacity: 20

Keywords: filing variations and extensions, Marketing Authorizations , types of variations, unclassified variations, Line extensions

Filing Variations in the European Union https://tess.elixir-europe.org/events/filing-variations-in-the-european-union The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections. The course will also provide the attendee with a thorough knowledge of the following topics: •Overview of the different types of variations and the different procedures for a Marketing Authorizations in the EU •The different types of variations (Type IA, Type IB, Type II) •Variations involving product information •How to deal with unclassified variations •Line extensions •Work-sharing 2017-10-18 09:00:00 UTC 2017-10-19 17:00:00 UTC The Center for Professional Innovation & Education The Berlin Hilton, Berlin, Germany The Berlin Hilton Berlin Germany [] info@cfpie.com The Center for Professional Innovation & Education PharmaceuticalMedical DeviceBiotech 20 workshops_and_courses [] filing variations and extensionsMarketing Authorizations types of variationsunclassified variationsLine extensions