Training - Preparing and Writing Module 3 (CTD)

Event Brochure

Date:
20-01-2020 - 21-01-2020

Venue:
Novotel
Av. José Malhoa 1 1A, 1099-051 Lisboa
1099-051 Lisbon

Description:


Ensure that your registration dossier has the precise documentation required to achieve the quickest turnaround in your submission.

This 2 day course will provide you with a clear understanding of the regulatory and technical requirements for Module 3 (CTD) of your application in the major markets of Europe and US.


What will I learn?

  • Compile and submit Module 3 (CTD) of your registration dossier
  • Create the correct documents within Development
  • Identify extent of content expected by regulators
  • Gain practical experience through examples
  • Ensure that Module 3 (CTD) of your dossier contains all data needed
  • Achieve the quickest turnaround of your submission
  • Compile and submit the Quality and Pharmaceutical section of your registration dossier in Europe and US
  • Ensure suitability of data from your development and manufacturing groups
  • Deal effectively with regulator: meeting the legal framework and guidelines for the CMC/ Quality part of the dossier.
  • Incorporate Quality By Design into your CTD requirements and create the optimal Module 3
  • Understand the benefits of high quality Module 3 on ensuring your product is maintained on the market


Find out more about our experienced trainer Andrew Willis and consult the schedule of the training in the event brochure.


Benefit from our promotional campaign: be one of the first ten registrations and get a registration fee of €750+ VAT.

To learn more about our services, please feel free to contact us.

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