Advanced CMC MasterClass
Online MasterClass | 20-21 October, 2021
Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC. The course covers general requirements for small molecules and biologics.
Methodology
The participants will gain knowledge via lecture-type sessions, letting substantial time for Q&A and discussions. Furthermore the training places great emphasis on practical examples through case studies.
Advanced CMC MasterClass
Online MasterClass | 20-21 October, 2021
EVENT INTRODUCTION
Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC.
The course covers general requirements for small molecules and biologics.
Who should attend?
• Quality assurance specialists
• Regulatory Affairs CMC authors or reviewers
• Analytical and stability laboratory
• Project managers with CMC
• Chemistry, Manufacturing & Controls (CMC) regulatory
• Product scientists and test method technical experts (R&D and QC)
• Process analytical chemists and process development scientists
Past Clients
Testimonials
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The level of professionalism of the trainer. Fine-tuned program without wasting time
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Managing Director – European pharma company
Testimonials
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Clear and interesting way of presenting issues, good examples and very knowledgeable trainer.
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HR Director - Multinational company based in Europe
Testimonials
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Excellent trainer, super skilled, funny and extremely dynamic
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M&A Professional
Testimonials
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This training was interesting and I would love to attend more trainings like this.
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HR Professional
Testimonials
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All lectures of the trainer was exactly what I was looking for and it was directly related to my experties and area that I am working. On top of that he prepared all lectures in a very practical way and also took his time to asnwers to the questions and he made sure that we got the asnwer. The organization of this class was also very good.
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Pharmaceutical professional
Testimonials
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Comprehensive overview with very knowledgeable and experienced trainers. The break-out sessions were great as they made the course more interactive and allowed us to apply the concepts in practice.
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Banking professional from Europe
About GLC EUROPE
Global Leading Conferences is specialized in designing, creating and executing impactful, and pragmatic Conferences, Masterclasses and in-house training.
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GHAZAL ZOHREHNEJAD
Managing Director / Co-founder
LÁSZLÓ ÁRVAI
Managing Director / Co-founder
KRISZTIÁN ÖTVÖS
Managing Director / Co-founder