European Union (EU) workshop on ICH Q3D from a quality perspective

• Date:
  Tuesday, 5 April 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The new ICH Q3D guideline on elemental impurities will be the subject of a workshop at the European Medicines Agency (EMA) between EU regulators, the European Pharmacopoeia and the pharmaceutical industry. The workshop will focus mainly on the quality aspects of the guideline and its implementation in the European regulatory system. The training modules developed and endorsed by the Q3D Implementation Working Group will be used as a basis for the material presented at the workshop.

Documents

Agenda - European Union workshop on ICH Q3D from a quality perspective

Reference Number: EMA/INS/189297/2016

Summary of the European Union workshop on ICH Q3D from a quality perspective

Reference Number: EMA/INS/158905/2016

Presentation - Implementation of the ICH Q3D guideline in the Ph. Eur. (Bruno Spieldenner)

Summary:

European Union workshop on ICH Q3D from a quality perspective

Presentation - Implementation of ICH Q3D in the CEP procedure (Helene Bruguera)

Summary:

European Union workshop on ICH Q3D from a quality perspective

Presentation - European Union regulatory perspective and expectations (Sven-Erik Hillver)

Presentation - Administration by other routes and other safety aspects (Anja Slikkerveer)

Presentation - Development of safe levels of elemental impurities: ICH Q3D (Dominique Masset)

Presentation - Elemental impurity risk assessment: case studies (Andrew Teasdale, Laura Rutter)

Multimedia