Advanced CMC MasterClass
13 & 14 June, 2022
This online masterclass will go through the key scientific points for the development and registration of your medicine.
This Masterclass 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, and also this training covers general requirements for small molecules and biologics.
13 & 14 June, 2022, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This training 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. This online training will covers general requirements for small molecules and biologics.
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Who should attend?
• Quality assurance specialists
• Regulatory Affairs CMC authors or reviewers
• Analytical and stability laboratory managers (R&D through GMP)
• Project managers with CMC responsibilities
• Chemistry, Manufacturing & Controls (CMC) regulatory
• Product scientists and test method technical experts (R&D and QC)
• Process analytical chemists and process development scientists
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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Years of experience
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