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Global CTD Dossier – Regulatory aspects and focus on quality documentation including concepts of Quality by Design

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Overview 

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

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