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Preparation of a Successful CTD with Quality by Design (QbD)

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The workshop will share and discuss requirements and experience on how to build up a high quality  CTD dossier with focus on quality  elements, considerations during  the development of a new medicinal product (MP), and practices  for compiling a high quality dossier  for successful global submission  and review for generic products.

Featured Topics
  • CTD, eCTD
  • Drug Legislation and Drug Regulation
  • Residual Solvents – Case Study
  • ICH Q8/Q9/Q10 and Q11 Quality by Design
  • Communication Between Authority and Industry – Case Study
  • Quality Target Product Profile – Interactive Workshop
  • Quality Risk Management – Case Study

Learning Objective
  • 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 with Quality by Design
  • Discuss the legal background of the dossier requirements and identify the relevant guidelines
  • Demonstrate optimal presentation of information and justifications for regulatory submissions


Who Should Attend
  • Reviewers from Regulatory Agencies
  • Pharmaceutical Industry Professionals
  • Regulatory Affairs, and R&D Professionals
  • Quality Assurance and Manufacturing Professionals


Program Committe Co-Chairs


General Manager, Nanjing Medichem Bio-Pharmaceutical Development Co.


Melly LIN

Regulatory Manager Technical Regulatory Policy, Roche (China) Holding Ltd.


Key Instructors

Christa Wirthumer-Hoche PhD

Head of Austrian Medicines and Medical Devices Agency (AGES)

Head of Institute for Marketing Authorisation of Medicinal Products and Lifecycle Management

Fritz ERNI PhD

CMC Consultant

Switzerland Member of the ICH Q8 Expert Working Group and ICH Q8/Q9/ Q10 Implementation Working Group Topic

Leader of the European Industry (EFPIA) for Drug Impurities

Program Agenda [Download PDF]
Day 1 | December 8, Monday



Welcome and Introduction


Session 1: China CTD Requirements and Practices  

CFDA Speaker Invited


Session 2: Drug Legislation and Drug Regulation

Christa Wirthumer-Hoche PhD

  • Development  of drug legislation
  • Drug regulations in the EU
  • Regulatory  bodies, structure, responsibilities
  • Communication  with and between regulatory agencies

Coffee Break


Session 3: Introduction to the Common Technical Document Structure of the licensing dossier

Christa Wirthumer-Hoche PhD

  • Structure of the CTD (Module 1 – 5)
    • Relevant guidance  documents
    • Focus on Module 3 - Quality
  • eCTD
    • current guidance documents
    • readiness to prepare (by industry) and accept eCTD (by authority)
    • future of the eCTD

Session 4: Quality of Active Substance - necessary documentation

Christa Wirthumer-Hoche PhD

  • Active Substance
    • Active Substance Master File
    • Certificate of Suitability
  • Impact of the EU-Directive on Falsified Medicines

Session 5: Impurity testing : Experience and new trends of ICH Q3A/B/C

Fritz Erni PhD

  • Impurities in drug substance
  • Degradation products in drug products
  • Residual solvents

Coffee Break


Session 6: Case Study Residual Solvents

All Participants


Day 2 | Tuesday, December 9

Session 7: Specific Requirements for Different Types of Applications

Christa Wirthumer-Hoche PhD

  • Information for bibliographical applications
    • Legal provisions concerning well established use applications
  • Information for generic, “hybrid” or bio-similar applications
    • Legal provisions concerning generics
    • Data protection period
  • Information for Informed Consent Applications

Coffee Break


Session 8: Quality Risk Management

Fritz Erni  PhD and Christa Wirthumer-Hoche PhD

  • Introduction to the Quality Risk Management and to the case study
  • Start working in groups
  • Discussion of the case study
  • Risk based review
Lunch Break

Session 9

Fritz Erni PhD

  • Stability testing
    • Discussion of the relevant guidelines
    • Practical examples
  • Setting of Specifications

Coffee Break


Session 10: Case Study

All Participants


Day 3 | Wednesday, December 10

Session 11: Pharmaceutical Development (3.2.P.2)

Fritz Erni  PhD

  • Discussion of important chapters
  • ICH Q8/Q9/Q10 and Q11 Quality by Design
    • What is Quality by Design
    • What are the optional possibilities and opportunities
    • ICH Q8 – drug product, ICH Q 11  - drug substance
    • Quality Risk Management (Q9) and how to implement Quality
    • Risk management in a dossier

Coffee Break


Session 12: The EU Regulatory Process

Christa Wirthumer-Hoche PhD

  • Centralized / Decentralized / Mutual Recognition Procedure
  • QbD – views of the regulators
  • Cooperation between assessors and inspectors
Lunch Break

Session 13: Case Study

Fritz Erni  PhD and Christa Wirthumer-Hoche PhD

  • Planning and organising a Meeting with authority
    • Scientific Advice, Pre-submission meeting, oral hearing during a procedure

Coffee Break


Session 14: Maintenance of Marketing Authorisations

Fritz Erni  PhD and Christa Wirthumer-Hoche PhD

  • Variations / Post approval changes
  • Legal framework
    • Definition of Variations
    • Classification of a variation
    • Procedural Guidance               
  • New provision for variations, to enhance regulatory flexibity
    • Post Approval Management Protocol
  • The Classification Guideline

Final Discussion & Closing Remarks


Type Sales End Price


2014-12-10 16:30 ¥3500


2014-12-10 16:30 ¥4300


2014-12-10 16:30 ¥2600


2014-12-10 16:30 ¥3400

Academia/ Nonprofit-Member

2014-12-10 16:30 ¥2600

Academia/ Nonprofit-NonMember

2014-12-10 16:30 ¥3400
Amount: ¥ 0

Date Time

2014-12-08 09:00 - Start

2014-12-10 16:30 - End

8 22 57
  • 中国 上海 杨浦区
  • Shanghai, China

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