Preparing and Writing the Common Technical Dossier (MODULE 3)

Event Brochure

Date:
26-02-2018 - 27-02-2018

Venue:
Phagecon - Serviços e Consultoria Farmacêutica, Lda.

1070-325 Lisboa

Description:

TARGET:

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 major markets of European and USA markets.


We will teach you how to:

  • Compile and submit Module 3 (CTD) of your registration dossier
  • Create the correct documents within Development
  • Identify extent of content expected by regulators
  • Provide practical experience and examples
  • Ensure that Module 3 (CTD) of your dossier contains all data needed
  • Achieve the quickest turnaround of your submission
  • Deal effectively with regulators
  • Compile and submit the Quality and Pharmaceutical section of your registration dossier in Europe and US
  • Ensure all data needed has been collected
  • Ensure suitability of data from your development and manufacturing groups
  • Deal effectively with regulators, meeting the legal frame-work 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
  • Understand the regulatory legal framework and influences on your Module 3 style

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

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