EU Variation Overview Regulatory Lectures by Rajashri Ojha at Raaj Pharmaelearning

Brief recap on registration of Pharmaceutical Products in Europe
Introduction of Product Life Cycle Management of Pharmaceutical Products in Europe
EU Variation Applications
Concept of “Variation” to the terms of Marketing Authorization

Variation classification guideline for European Union

Types of Variations

Definitions each type of variation,
fundamental concept & examples

Documentation required for variation filling

Grouping of variations

Timelines of variations
EU Renewal Applications
Concept of “Renewal “ to the terms of Marketing Authorisation
Renewal submission timelines
Documentation required for Renewal filling
Takeaway message to people working for Product Life Cycle Management of Pharmaceutical Products

[@pranamks5104]

Thank you so much! helpful for interview

[@rajeshponnam3790]

Thank you! very nice.
Could you help me the following query: major difference between Type II variations via NP and MRP/DCP?

[@nyari9317]

Thank you :)

[@shitalrasal745]

Thanks ma'am, very nice.
Will u please share previous video link

[@muazhababa6858]

cant thank you enough for this very good presentation ( you are very experinced in RA )

[@dnyaneshwarpanchal3307]

Very nicely explain.......🙏🙏🙏🙏👍👍

[@bantysharma1508]

Thanks mam. I appreciate you; I think you were not feeling well during this session, but you studied in a good way... thanks a lot.

[@AnnuKumari-np5us]

Very well explained mam 🙏

[@mallidiasha4941]

Wow super mam👍💯

[@PrathibhaChinna]

Please share the link of previous session on EUrope appovel time lines

[@mohandasdere8417]

Nice explained, I need to understand p. 5.5

[@vasavinarigandla6586]

Thank you so much madam, it helped me alot.

[@Learnwithsimon27]

very nice presentation.

[@nooshafarinhirad9774]

thanks a lot for such a valuable presentation or Article