Session 1: Introduction to Analytical Procedure Life Cycle for ATMPs
- Overview of regulatory requirements and guidelines for ATMPs
- Importance of analytical procedure life cycle in ATMP development and manufacturing
- Key principles of analytical method development for ATMPs
Session 2: Method Selection and Optimization
- Criteria for method selection and optimization for ATMPs
- Analytical method development for cell-based and gene therapy products
- Statistical analysis of method performance parameters
Session 3: Analytical Method Validation
- Overview of analytical method validation parameters for ATMPs
- Method validation design and execution
- ICH Q2 guidelines and their application to ATMPs
Session 4: Analytical Method Transfer and Lifecycle Management
- Key principles of method transfer for ATMPs
- Development and implementation of analytical method transfer protocols
- Analytical method lifecycle management for ATMPs
Session 5: Regulatory Considerations for Analytical Procedures for ATMPs
- Regulatory requirements for analytical procedures for ATMPs
- Submission strategies for analytical procedures in ATMP regulatory submissions
- Common issues and challenges in analytical procedures for ATMPs
Session 6: Case Studies and Interactive Exercises
- Case studies on analytical procedure life cycle in ATMP development and manufacturing
- Interactive exercises on method selection, optimization, validation, and transfer for ATMPs
- Q&A and wrap-up
This two-day masterclass provides a comprehensive understanding of the Analytical Procedure Life Cycle for ATMPs, covering all key aspects from development to implementation and maintenance. It is ideal for professionals in ATMP development, manufacturing, quality control, and regulatory affairs, who want to gain in-depth knowledge and practical skills in analytical method development and validation for ATMPs.
The masterclass will be led by a team of experienced industry professionals with a proven track record of success in the development, manufacturing, and regulatory affairs of ATMPs.
This masterclass is ideal for professionals involved in ATMP development, manufacturing, quality control, and regulatory affairs. This includes scientists, engineers, regulatory affairs specialists, quality control personnel, and other professionals working in the field of ATMPs.
The fee for attending this two-day masterclass is 1,199 € per person. However, if six or more attendees register from the same company, a 30% discount will be applied to the total registration cost. This includes all course materials during both days. Attendees will also receive a certificate of attendance upon completion of the masterclass.
Note: the 30% discount will be applied to the total registration cost of all attendees from the same company. For example, if six attendees register from the same company, the total cost for the group will be discounted by 30% of the original price, bringing the total registration cost down to 839.3 € per person. This discount applies to all attendees from the same company who register for the course.