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CMC Biopharma MasterClass

CMC Biopharma MasterClass

Join our CMC Biopharma MasterClass on 21st-22nd March, 2019 in Vienna, Austria!

 

This CMC Biopharma 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.
 

By the end of the MasterClass, the participants will understand: 

• Process development strategies
• Analytical and Formulation development
• GMP manufacture
• Process analytical Technology
• Guidelines and Regulatory pathways for New Biological entities and Biosimilars

When

21 Mar 2019 @ 08:00 am

22 Mar 2019 @ 08:01 am

Duration: 1 days


Where

Austria Trend Hotel Vienna

10 Hietzinger Hauptstraße

1130 Wien

Austria


Organised by

GLC Europe

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This research policy workshop will focus on how to move forward the innovation chain in the EU for bioenergy, advanced biofuels and renewable fuels, contributing to the clean energy transformation in energy and transport, in line with the Strategic Development Goals and the EU Communication “Clean Planet for All”. For this purpose, the workshop will identify the research and innovation needs, the strategy and the roadmap for bioenergy, biofuels and renewable fuels to make the European industrial energy and transport sectors economically and environmentally sustainable, secure and competitive in the global markets. The agenda will focus on the value chains of advanced biofuels, renewable fuels, intermediate bioenergy carriers and biomass-based cogeneration of heat and power. The entire innovation sequence will be discussed, from breakthrough technologies to applied research and demonstration, pre-commercial scale financing and market up-take support measures. Results from the entire portfolio of around 60 projects supported under the European Union’s Framework Programme Horizon 2020 – Secure, clean and efficient energy challenge will feed into the discussion. The views of the engaged EU Member States and of research and industrial stakeholders will be an important additional contribution, to identify non-technological support pathways through new tools, research concepts, the mobilization of national actions, private engagement and financing mechanisms. The workshop will then report on the progress of the innovation chains, the effectiveness of pushing innovative solutions into the market and their broader penetration into the energy and transport mix. Policy recommendations based on project results, the Member States’ interests and plans, as well as the views of the stakeholders, will also be collected and reported.

@http://ec.europa.eu/research/index.cfm?pg=events&eventcode=3AED3292-ED14-0D64-22761AA7F9CB5D9B - 21 Mar 2019 10:11

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@inea_eu - 21 Mar 2019 09:35

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@EU_ScienceHub - 21 Mar 2019 09:04

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