Advanced CMC MasterClass - US edition
29-30 May, 2024
The course covers general requirements for small molecules and biologics
Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, and the products themselves are becoming more and more complex.
29-30 May, 2024, Virtual
Time Zone: Eastern Daylight Time (EDT)- UTC−04:00
Overview
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.
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RECOMMENDATION
Who should attend?
• Quality assurance specialists
• Regulatory Affairs CMC authors or reviewers
• Analytical and stability laboratory managers
• 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
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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