CMC SPIN Webinar: Nitrosamine Risk Assessment for New MAAs

CMC SPIN Webinar: Nitrosamine Risk Assessment for New MAAs
CMC SPIN Steering Group presents this webinar on Nitrosamine Risk Assessment.

Date: Tuesday 14 September 2021
Time: 14:00 – 15:00 BST (GMT+1) / 15:00 – 16:00 CEST
Location: Online


Agenda

  • Welcome and Introduction by Michal Mista, Director of Xyzum Regulatory Ltd and CMC SPIN Steering Group Member
  • Presentation of EU and US Guidelines
  • How to conduct a Risk Assessment?
  • Next steps in case of a positive Risk Assessment
  • Q&A Session

 

SPEAKERS:

  • Sheetal Gaiki from J&J
  • Diego Martinez from PharmaLex
  • Dr Meike Vanhooren from Pfizer and CMC SPIN Steering Group member



Pricing

  • Members: free
  • Non-members: £45 (includes two months of TOPRA membership)

 

How to register

Members:

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Please note:  This Webinar is now fully booked.   Please email membership@topra.org to be added to the waiting list.
When
14/09/2021 14:00 - 15:00
Where
ONLINE
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