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Biosimilars Training

Biosimilars Training

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Biosimilars Training

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Presentation Transcript

  1. Aurelius Global Masterclass LearnFromTheBest In TheWorld

  2. Hello! I am Sumit Peer CEO Of Aurelius Global Masterclass I am here to show you some of our work like who are we and what we do.

  3. About us Aurelius Corporate Solutions wants to be seen and accepted as one stop shop for all industry specific master-classes across the globe, thereby making the line managers well versed with the acceptable technology and business practices, adopted worldwide.

  4. So as you know about us. Let’s begin the journey of masterclasses we provided for years. As we are specialist in this field So let’s go

  5. Some Of Our Masterclass Clinical Trials Regulation Biosimilars Clinical Development Well Plugging And Abandonment The Masterclasses We Provided Is Taught By The Best Professionals In There Fields.

  6. Biosimilars Clinical Development 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 biosimilarstudies

  7. KEY TAKEAWAYS  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

  8. A Picture Is Worth A Thousand Words

  9. Our Social Medial Platforms Facebook YouTube Instagram

  10. Venue & Date Start Time 9:00 am November 14, 2019 Finish Time 5:00 pm November 15, 2019 Address Amsterdam, The Netherlands

  11. Region Europe 19,450000

  12. Thanks! Any questions? Email: aureliusglobalmasterclass.com Phone: +44 2032 398083