Past
Event
Save the date for

Manufacturing of Biologics and Biosimilars

14. April - 15. April 2016
Sheraton Munchen Westpark Hotel, Garmischer Strasse 2, Munich, Germany

More about the Venue

SUMMARY

Delegates will receive Certificate of Completion issued by the Trainers.

Key Topics

  • CMC Intro
  • Materials-Manufacturing-Control
  • Regulatory Requirements
  • Overview Drug Substance-Manufacture
  • Critical Process Parameters In-Process controls for DS-Manufacture
  • Overview Drug Product-Manufacture
  • CPPs and IPCs for DP-Manufacture
  • Statistics in Manufacturing

Why to attend

Understand
  • The essentials of manufacturing of biosimilars
  • Why formulation does not need to be identical
Learn
  • About different regulatory requirements US/EU/ROW
  • About drug product and drug substance
  • About critical process parameters
Gain
  • Knowledge on statistics in manufacturing
  • Knowledge on cell line development

Trainers

Who should attend

By position

Vice Presidents, Directors, Heads

Managers

Scientists

By industry

  • Biologics
  • Biosimilars
  • Biobetters
  • Biotechnology
  • Biotherapeutics
  • Analytical Science
  • Process Science
  • Research & Development
  • Regulatory Compliance
  • Quality Assurance
  • Quality Control
  • Intellectual Property
  • Clinical Immunology
  • Scientific Affairs
  • Business Development
  • Portfolio planning
  • Legal Affairs
  • Pharmacovigilance

Want to know more?

Stay tuned for event updates!