www.glceurope.com CMC Biopharma MasterClass • 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 • Have a chance to meet the Requirements and technical approach for Phase I, Phase II, Phase III clinical trials • Learn about the Control strategy life cycle • Understand the ICH guidelines and Regulatory pathways for New Biological entities and Biosimilars in EU and USA HOW YOU WILL BENEFIT: www.glceurope.com 27-28 July, 2020 Online MasterClass • 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 • Have a chance to meet the Requirements and technical approach for Phase I, Phase II, Phase III clinical trials • Learn about the Control strategy life cycle • Understand the ICH guidelines and Regulatory pathways for New Biological entities and Biosimilars in EU and USA HOW YOU WILL BENEFIT: Andreu Soldevila CMC Biopharma MasterClass Join the training to get a detailed instruc�on on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registra�on and post approval drug applica�ons
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www.glceurope.com
13-14 February, 2020 Novotel Budapest Danube Budapest, Hungary
CMC Biopharma MasterClass
• 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
• Have a chance to meet the Requirements and technical approach for
Phase I, Phase II, Phase III clinical trials
• Learn about the Control strategy life cycle
• Understand the ICH guidelines and Regulatory pathways for New
Biological entities and Biosimilars in EU and USA
HOW YOU WILL BENEFIT:
www.glceurope.com
27-28 July, 2020 Online MasterClass
• 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
• Have a chance to meet the Requirements and technical approach for
Phase I, Phase II, Phase III clinical trials
• Learn about the Control strategy life cycle
• Understand the ICH guidelines and Regulatory pathways for New
Biological entities and Biosimilars in EU and USA
HOW YOU WILL BENEFIT:
Andreu Soldevila
CMC Biopharma MasterClass
Join the training to get a detailed instruc�on on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registra�on and post approval drug applica�ons
By THE END of THE MASTERCLASS, THE PARTICIPANTS wILL UNDERSTAND:
wHo SHoULD ATTEND?
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. Practical examples will be provided as illustration and proper time will be
allowed for discussion designs and outcomes.
• Process development strategies
• Analytical and Formulation development
• GMP manufacture
• Process analytical Technology
• Guidelines and Regulatory pathways for New Biological entities and Biosimilars
• QC release and stability analysts• Stability program managers• Product scientists and test method technical experts (R&D and QC)• Process analytical chemists and process development scientists• Quality assurance specialists• GMP compliance auditors• RegulatoryaffairsCMCauthorsorreviewers• Analytical and stability laboratory managers (R&D through GMP)• Project managers with CMC responsibilities• Business managers with CMC responsibilities• Keystafffrombiotechacademicincubatorsandsmallstart-ups• Contract testing labs• Chemistry, Manufacturing & Controls (CMC) regulatory• biopharmaceuticals, biosimilars or other biologics• Executive and operational managers of pharmaceutical companies, packaging operations• Engineeringstaff• Quality• Product Development Materials handling/management• Product Information Operations• Licensing• Biotech companies HTAs• Governments• Engineering Lean production• Procurement• Purchase/Facilities Manufacturing Technology• Supply chain and logistics• Payers
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