Masterclass

This course will cover the Analytical Procedure Life Cycle for Advanced Therapy Medicinal Products (ATMPs), from development to validation, implementation, and maintenance, including regulatory requirements, method selection, optimization, validation, and lifecycle management. Ideal for professionals in ATMP development, manufacturing, quality control, and regulatory affairs.

 

Masterclass

This course will provide an in-depth understanding of Chemistry, Manufacturing, and Controls (CMC) requirements for Cell Therapy Products (CTPs), covering regulatory landscape, cell sourcing and characterization, product design, manufacturing processes, and quality control. Ideal for professionals involved in CTP development, manufacturing, quality control, and regulatory affairs.

 

This course will provide a comprehensive overview of Chemistry, Manufacturing, and Controls (CMC) requirements for Gene Therapy Products (GTPs), covering regulatory landscape, vector design and characterization, manufacturing processes, quality control, and stability. Ideal for professionals involved in GTP development, manufacturing, quality control, and regulatory affairs.

 

This course will cover the fundamentals of stability testing for drugs and biologics, including regulatory requirements, stability study design, analytical methods, and data analysis. Ideal for professionals involved in drug and biologics development, manufacturing, quality control, and regulatory affairs.

 

This course covers the regulatory requirements, method validation parameters, and best practices for analytical method validation and transfer for pharmaceutical products. Ideal for professionals involved in drug development, manufacturing, quality control, and regulatory affairs.

 

This course provides a comprehensive understanding of the European Union (EU) Good Manufacturing Practice (GMP) requirements for Advanced Therapy Medicinal Products (ATMPs), covering implementation strategies, quality management systems, and compliance. Ideal for professionals involved in ATMP development, manufacturing, quality control, and regulatory affairs.

 

Workshop

This workshop provides practical training in the fundamentals of global clinical research, including clinical trial design, conduct, and reporting, as well as regulatory requirements and ethical considerations. Through interactive exercises and case studies, participants will gain valuable skills for successful clinical research. Ideal for professionals involved in clinical research, including investigators, study coordinators, monitors, and regulatory affairs personnel.

 

Workshop

This workshop provides an overview of manufacturing and regulatory processes for pharmaceutical and biopharmaceutical products, including drug development, process validation, quality control, and regulatory submissions. Through case studies and interactive exercises, participants will gain a solid understanding of the key principles of manufacturing and regulation. Ideal for professionals involved in drug development, manufacturing, quality control, and regulatory affairs.