Objectives

This conference will provide information about the changes in the Annex 2 and the impact of these changes on biopharmaceutical development and manufacturing. Expert speakers from authorities, industry and laboratories with experiences on different types of biopharmaceuticals, e.g. vaccines, gene therapeutics  ATMP, will present their experiences on implementation of the Annex 2. They show you the regulatory requirements as well as practical approaches to realize GMP standards in biopharmaceutical development and manufacturing companies. It will be a unique chance to discuss the different points of view with speakers and colleagues.

Target Group

Responsible persons from biopharmaceutical industry, laboratory, research institutions and authorities who are involved in

• Quality Control
• Quality Assurance
• Regulatory Affairs
• Research and Development
• Audits and Inspections
  

Registration

To register for this course please see the Registration Options.