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CMC Analytical Comparability: Methods & Strategies for Biologics

  • 18 – 19 February 2025
  • Rome, Italy
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CMC Analytical Comparability: Methods & Strategies for Biologics

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Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer

Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation
meet the training leaders
Johannes Buchner | Fleming
Prof. Dr. Johannes Buchner
Dept. Of Chemistry
Technische Universität München, Germany
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Robert Zoubek | Fleming
Linkedin
Dr. Robert E. Zoubek
Executive Consultant
Granzer Regulatory Consulting & Services, Germany
View trainer bio
Markus Roucka | Trainer | Fleming
Linkedin
DI Markus Roucka
Head Business Development
Tentamus Pharma DACH, Austria
View trainer bio
Andre Abts | Trainer | Fleming
Linkedin
Dr. André Abts
Vice President Project Management CMC
ProtaGene, Germany
View trainer bio
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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CMC Analytical Comparability Methods and Strategies For Biologics training organized by Fleming_Agenda Cover
CMC Analytical Comparability Methods and Strategies For Biologics training organized by Fleming_Agenda Cover
CMC Analytical Comparability Methods and Strategies For Biologics training organized by Fleming_Agenda Cover
key training

Topics

Analytical Comparability of Biologics, Biosimilars & Biobetters

Comparability in Biologics Development

The analytical strategies of protein characterization of Biologics & Biosimilars

New developments in structure function relationship

The structure of proteins

In vitro pharmacology

Benefits of attending

  • Understand
    • The regulatory requirements for characterization, comparability, similarity
    • Principles of protein structure and comparative analytics

  • Learn
    • How to define Protein Analytical Program & Critical Quality attributes
    • To design of an analytical strategy for comparability / similarity studies

  • Gain
    • Five steps to demonstrate comparability
    • New developments in Structure/ Function relationship
    • Protein Characterization according to ICH Q6B

Testimonials

Professional trainers, interesting presentations, helpful knowledge.
Edyta SmolińskaPolpharma Biologics
Very interesting course. The trainers are of a great value.
Sonia Ben AmorMOH
Really enjoyed the conference experience, content and organization. Overall it was a superb experience.
Stefanie Eggermont Associate Scientist, UCB, Belgium
I wish I had received this training earlier, it's very interesting, I'm glad I participated.
Daniela GantarProject Manager QC, Boehringer Ingelheim, Austria
The organization was excellent! It was an ideal forum for a CMC regulatory professional to learn more about analytical comparability methods and network with experts from pharma, biotech, CMOs, analytical service companies and regulatory authorities.
John Watkins PhDSenior Regulatory Affairs Manager, PPD, UK
A great posibility for networking with colleagues across the globe and share the best practices. I will try to use the received knowledge in my daily working life!
Natalia MorgunovaBACIS RA Head, Novo Nordisk, Russia
All content was precisely determined, informative and helpful. Instructors were great also. Thank you very much, it was a pleasant and beneficial experience.
Duygu DaglikocaBiotech R&D Lab Executive, Ilko Pharma, Turkey
I loved being here. The professionals were open to questions & were very warm answering them. I personally learned a lot.
Sachin TendulkarResearch Leader, Reliance Life Sciences, India
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Training tickets

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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

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