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Comparability for Biologics

3 - 4 April 2019

Reed Messe Wien Congress Center, Vienna

Process changes made during the manufacture of recombinant proteins can have profound implications. This 2-day course provides valuable insight into the quality, safety, efficacy and regulatory impact of manufacturing changes and how to manage process change to guarantee regulatory compliance and product consistency at all times. It features numerous case studies from industry and practical advice from our experienced professionals on the best ways to satisfy the needs of the regulators and understand how various process changes may impact the success of your products.

  • Gain insight into the inter-relationship between process change, quality, safety and efficacy
  • Examine the importance of change control, Good Manufacturing Practice (GMP) and the potential of Process Analytical Technology (PAT)
  • Discuss the potential significance of various process changes and how these may impact the quality of your products
  • Understand the physicochemical and biological analytical tools available to monitor the impact of process change
  • Hear about the non-clinical and clinical testing programmes that might be required to support major process change
  • Analyse the US and EU regulatory requirements following process change

Dr. Robert E. Zoubek

Dr. Robert E. Zoubek is an expert in the development, manufacturing, and analytics of biologics, as well as regulatory affairs. Until he joined Europe´s leading Consultancy Company, Granzer Regulatory Consulting & Services, he worked in several different positions at Formycon (Germany) and GlycoForm (UK).  As Director of Scientific Affairs, Robert led Formycon´s drug product development and analytical services.

This course is suitable for anyone working in:

  • Manufacturing
  • Analytics
  • Regulatory affairs
  • Quality assurance
  • Project Managers

                                                             Course Reviews

 “There was great interaction during the course as there was a small group and the open discussion was invaluable.”

Head of Operations, Ganymed Pharmaceuticals AG

“The course was perfect. There was a good balance between the theory of comparability and material exercises.”

Senior Regulatory Strategy Manager, LFB Biotechnologies

“The practical sessions were very useful and the course content was excellent.” 

Manager in Global Regulatory Affairs, GSK Vaccines

I enjoyed the insight we were given from actual projects and the case-by-case discussions.

Senior Consultant, Michor Consulting

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