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27 - 28 Jul 2020Ended

CMC Biopharma MasterClass

About 1Session 1SpeakersExhibitorsReviews 4Photos

Entry Fees

Free ticket

Official Links

Estimated Turnout

40
Delegates
Based on previous editions

Editions

27 - 28 Jul 2020

Frequency

Annual
Next edition likely in Jul 2021
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"Experience the development of biotherapeutics from Discovery to Market approval"
Join our upcoming CMC Biopharma MasterClass which will be streamed ONLINE on 27-28 July, 2020 and will be led by Dr Andreu Soldevila, Founder and CEO .. Read more of Leanbio and Co-founder and CEO of Syna Therapeutics. This MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. For more information, download the Agenda!

Highlights

  • Take a closer look on the new Biological entities and Biosimilars
  • Experience the development of biotherapeutics from Discovery to Market approval
  • Understand the Strains and Cell line development
  • Learn about the Control strategy life cycle and understand the ICH guidelines
  • Understand the regulatory pathways for New Biological entities & Biosimilars in EU & USA
Mon, 27 Jul
Session
Introduction to Biologics
ANDREU SOLDEVILA
ANDREU SOLDEVILA CEO, Leanbio
Speaker
ANDREU SOLDEVILA

ANDREU SOLDEVILA

CEO, Leanbio
Free Delegates Visit website for price
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Monica

Monica

Research Student at Karachi university

Karachi, Pakistan
Angela Butters

Angela Butters

Manager at WCHS

Sergeant Bluff, United States
Lenka Palova Jelinkova

Lenka Palova Jelinkova

lead scientist pharmacology at Sotio, a.c.

Prague, Czech Republic
Yuvaraj S

Yuvaraj S

Assistant Manager at Hyundai Mobis India

Chennai, India
Michele Fontenot

Michele Fontenot

Hospital Operations at Peoples Health

New Orleans, United States
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