Quality Content (ICH M4Q) of the Common Technical Document (CTD) for New Biotechnological Entities MasterClass - EU edition
21-22 May, 2024
Scope of the ICH Guidelines Q6B for biotechnological products
The Master Class focuses on ICH M4Q, providing guidance on the format and content of a registration application for drug substances and their corresponding drug products.
21-22 May, 2024, Virtual
Time Zone: UTC/GMT+1 /CET
Overview
The Master Class focuses on ICH M4Q, providing guidance on the format and content of a registration application for drug substances and their corresponding drug products, as defined in the scope of the ICH Guidelines Q6B for biotechnological products. The Master Class also includes links to other existing ICH guidelines and their contents.
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As of November 2006, I’ve been appointed Vice-President, Head of Biotech Process Sciences at Merck-Serono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemicallydefined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.
RECOMMENDATION
Who should attend?
• Regulatory professionals (CMC) responsible for creating a dossier
• Heads of CMC functions (e.g., Cell Line Development, Drug Substance Process Development, Analytical Development, Formulation and Drug Product Development)
• CMC Project Leaders
• Quality Assurance professionals
• Any other professionals responsible for generating data to be shared with regulatory authorities
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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