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Advancing Biosimilars Clinical Development

Biosimilar Clinical Trial

Biosimilars Event Date 18th to 19th November 2019, Location: Amsterdam, The Netherlands

OVERVIEW OF BIOSIMILAR CLINICAL DEVELOPMENT MASTERCLASS IN EUROPE

BIOSIMILAR CLINICAL DEVELOPMENT TRAINING FEATURES

  • Most up-to-date updates in regulatory and clinical areas around biosimilar developments.
  • How to mitigate various risks in designing and executing biosimilar studies
  • How to avoid delays and maximise regulatory success with biosimilar development
  • Understanding around tailored clinical development

KEY TOPICS OF BIOSIMILAR CLINICAL DEVELOPMENT MASTERCLASS

  • In this Biosimilars Clinical Development Masterclass participants will Introduction to biosimilar pathways in EU and US: experiences so far
  • In this Biosimilars Clinical Development Masterclass participants will Totality of the evidence and role of analytical data
  • In this Biosimilars Clinical Development Masterclass participants will Assessment of PK, PD, Immunogencity and safety in biosimilar studies
  • In this Biosimilars Clinical Development Masterclass participants will Tailored clinical development path
  • In this Masterclass participants will Most recent updated EMA and FDA requirements
  • In this Masterclass participants will Pharmacovigilance activities and risk management plan
  • In this Masterclass participants will Introduction to biosimilar pathways in EU and US: experiences so far

KEY TAKEAWAYS OF BIOSIMILAR CLINICAL DEVELOPMENT TRAINING IN AMSTERDAM

Participants will learn to:

  • EMA and FDA expectations for biosimilar clinical studies
  • What factors should be considered in design of the study
  • Working with analytics: understanding impact of residual uncertainties and differences
  • Selection of patient population
  • Study specific considerations for assessment of safety and immunogenicity
  • Interchangeability and where switching data will be required

Registration Fee


€2496


Per Participant


About Amsterdam, The Netherlands

Amsterdam, Austria’s capital, lies in the country’s east on the Danube River. Its artistic and intellectual legacy was shaped by residents including Mozart, Beethoven and Sigmund Freud.

Start Time

9:00 am

November 18, 2019

Finish Time

5:00 pm

November 19, 2019

Address

Amsterdam, The Netherlands

Our Facilitator