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Overview

Learn how to build up a CTD dossier with focus on Quality issues. What has to be taken into consideration during development of a new medicinal product (MP) – also a generic MP – compiling a dossier for successful global submission and review. The training includes case studies, interactive workshops and group works. The participants learn to understand the concepts behind the new ICH Q8, Q9, Q10 and Q11 guidelines (Quality by Design).

To Register, click here.

Featured topics

  • CTD, eCTD
  • Drug Legislation and Drug Regulation
  • Residual Solvents – case study
  • ICH Q8/Q9/Q10 and Q11 Quality by Design
  • Meeting between Authority and Industry – case study
  • Quality Target Product Profile – interactive workshop
  • Quality risk management – case study

Who should attend?

  • Regulatory agencies
  • Pharmaceutical industry professionals
  • Regulatory Affairs, and R&D professionals
  • Quality Assurance and manufacturing professionals

Learning objectives

  • Identify the recent requirements for developing drug substance and drug products and setting up a registration dossier
  • Define the requirements for developing a product and discuss how to prepare the ICH Q8/Q9/Q10 and Q11 Quality by Design
  • Discuss the legal background of the dossier requirements and identify the relevant guidelines
  • Demonstrate optimal presentation of information and justifications

Program Committee

  • Fritz  Erni, DrSc
    Fritz Erni, DrSc Consultant, ICH expert Switzerland
  • Yi  REN, PhD, MBA
    Yi REN, PhD, MBA General Manager Nanjing Medichem Bio-Pharmaceutical Development Co. , China
  • Melly  Lin
    Melly Lin Regulatory Manager Roche (China) Holding Ltd., China
  • Christa  Wirthumer-Hoche, PhD
    Christa Wirthumer-Hoche, PhD Head of Austrian Medicines and Medical Devices Agency Austrian Medicines and Medical Devices Agency, Austria
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Contact us

For general inquiries and registration, contact
Mr. Fei XIE
Phone +86.10.6260.2240
fei.xie@diachina.org or dia@diachina.org

To Register, click here.