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Quality Requirements for Biotech Products from First-In-Human to Phase III
26. April - 28. April 2017, Frankfurt

WHY TO ATTEND

Regulatory framework for Clinical trials of Biotech-IMPs

GMP requirements for IMPs,
IMPs comparators and placebos

Manufacturing of the Drug Substance and
IMP

Requirements for process validation,
The site master file (SMF)

TAKEAWAYS & SPECIAL FEATURES

  • Release specifications versus In-Process Controls, ICH guidelines

  • Manufacturing process changes during clinical development

  • Regulatory landscape for national CTA procedures

  • Voluntary Harmonized Procedure (VHP) in Europe

  • Quality challenges for Biotech-IMP development

  • ...and much more!

  • Certificate of Completion

  • Individual consultancy with the trainers

  • Interactive lecturing

  • Case studies from the trainer's experience

  • Comprehensive course documentation

  • 5H+ of Networking with other industry experts

Meet the expert trainers

Dr. Jörg  Engelbergs photo
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Dr. Jörg Engelbergs

Regulatory-scientific Expert at Paul-Ehrlich-Institut

Dr. Jörg Engelbergs is currently working for the Paul-Ehrlich-Institut in Langen as regulatory-scientific expert for polyclonal and monoclonal antibody based therapeutics, including biosimilars and f

Learn more about Dr. Jörg >

Dr. Robert  E. Zoubek photo
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Dr. Robert E. Zoubek

Senior Consultant at Granzer Regulatory Consulting & Services

Dr. Zoubek is passionate biochemist with large experience in the mitigation of protein aggregation and degradation, and the effective design of formulation studies - an experience which he combines wi

Learn more about Dr. Robert >

Who should attend

BY POSITION

• QC/QA Managers/Supervisors

• Pharmacovigilance

• Regulatory Managers and Specialists

• Biotherapeutics Analytical Scientists

• Process Science Research & Development

• Product Stability Managers and Specialists

• Drug Product Development Scientsts

• R&D Heads/Managers

• CMC Heads/Managers

• Biotech Products Formulators

Partners

Media Partner

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Media Partner

Join us in Frankfurt

Bristol Hotel Frankfurt

Ludwigstraße 15
60327 Frankfurt am Main
Germany

Visit the hotel's website.