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Module 3 of the Global CTD

7 - 15 October 2020

New LIVE Online Academy

Timings and dates are subject to change - final confirmation will be provided with login details
Session 1 - Starts 1pm BST on 7th October (lasting 3 hours)

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Understanding the Key aspects of the CTD Global Dossier & How to Think for Biological Medicines
  • Understanding the Key aspects of the CTD Global Dossier
  • Understanding differences between Small and Large Molecules
  • What is a QTPP
  • Key Terminology
  • CMC Linkage

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Structure and Content of the CMC Sections of The CTD and Introduction to Drug Substance Sections
  • Structure and Content of the CMC Sections – CTD Ruadmap
  • Introduction to Drug Substance Sections for Small Molecules and Biologics
  • EU and US DMFs explained
  • Linkage to Drug Product Section
  • Understanding Q11 – Basic Rules
Session 2 - Starts 1pm BST on 8th October (lasting 3 hours)

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Understanding the Reviewers Perspective – The CTD Equation and Importance of Development Pharmaceutics
  • This section examines in detail the development pharmaceutical sections of the dossier and highlight key mechanistic ways of ensuring we answer the reviewers questions.
  • CMC Linkage
  • The equation of The CTD
  • CQAs and CPPs explained
  • PAT eExplained
Session 3 - Starts 1pm BST on 14th October (lasting 3 hours)

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Overview of Drug Product Sections of the Dossier
  • These sections review each of the individual sections P.1 to P.8 of the  3.2.P section of the CTD, and key aspects for 3.2.R and 3.2.A sections
  • It address differences in data levels for different product types
  • It Examine critical section 3.2.P.5 and uses analytical data to demonstrate linkage and reviewer expectations.  Critically, it highlights the need for writing great justifications
Session 4 - Starts 1pm BST on 15th October (lasting 3 hours)

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Understanding Source Documents – Reviewers Perspectives ( Using Analytical for MAB examples)
  • Understanding Source Documents – Reviewers Perspectives ( Using Analytical as an example)
  • Highlights the needs of internal teams versus external reviewers
  • The QOS
  • Reviewers Questions to be answered

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Global Dossier and Importance of Dossier Redaction
  • Change Control and the Impact of your Dossier
  • Global Dossier Roll Out