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High quality of a registration dossier facilitates the registration procedure - Essential for Generics! This course provides a comprehensive description on the Common Technical Dossier structure – completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course provides an excellent opportunity to gain an overview of regulatory aspects and includes discussion of the relevant legislation. The requirements for the Quality documentation (Module 2.3 & 3) will be presented in detail, taking into account the recent ICH-Q guidelines. The course is for new developments, but is also very much attractive for Generics. In addition, this training course addresses Quality by Design aspects and issues.
Participants will be involved in case studies, group works and have to present the outcome.

Key Topics

 • CTD, eCTD
 • Regional requirements of EU Module 1
 • Regulatory environment:
  o New applications
  o Past approval changes
 • Risk based approach
 • Module 3
  o Pharmaceutical Development and Quality Risk Management
  o Quality of Active Substance including Purity Issues (ASMF, CEP)
  o Impurity Testing
  o Stability Testing
  o Setting of Specifications
  o Design Space
  o Control Strategy

Who should attend?

• Governmental Institutions
• Pharmaceutical Industry
 o Development Managers and Experts
 o QA and New Manufacturing Managers

Level: Beginner to intermediate

Learning objectives

At the conclusion of this course, participants should be able to:

  • Identify the recent requirements for developing drug substance and drug products and setting up a registration dossier - especially for generics
  • Define the requirements for developing a product and discuss how to prepare the regional EU Module 1 and the Quality documentation
  • Discuss the legal background of the dossier requirements and identify the relevant guidelines
  • Demonstrate optimal presentation of information and justifications

Contact us


Kuechengasse 16, POSTFACH

4002 BASEL


PHONE: +41 61 225 51 51

FAX: +41 61 225 51 52