Why attending the Masterclass: Stability Testing for ATMPs, Drugs, and Biologics
Attending the Masterclass: Stability Testing for ATMPs, Drugs, and Biologics provides an ideal opportunity to enhance your understanding of stability testing and gain insights into the best practices for developing and implementing stability testing programs. You will learn from leading experts in the field who have extensive experience in the design, execution, and interpretation of stability testing studies. This masterclass is an ideal opportunity to network with peers, share experiences, and gain new insights into the challenges and opportunities facing the pharmaceutical industry. By attending this masterclass, you will be able to develop and implement effective stability testing programs that are compliant with regulatory requirements, ensuring the quality, safety, and efficacy of your products.
By attending this Masterclass you will:
- Gain a comprehensive understanding of the regulatory requirements for stability testing and learn how to navigate the different guidelines and regulations in different regions around the world.
- Learn the best practices for developing and implementing stability testing programs for a wide range of products, including small molecule drugs, biologics, and advanced therapy medicinal products (ATMPs).
- Learn how to design and execute stability studies, interpret the data, and develop appropriate expiration dates for your products.
- Learn how to troubleshoot stability issues and develop effective strategies to address them.
- Network with peers, exchange ideas and experiences, and gain new insights into the challenges and opportunities facing the pharmaceutical industry.
Day 1:
Session 1: Introduction to Stability Testing
- Regulatory requirements for stability testing
- Types of stability testing: real-time, accelerated, and forced degradation
- Understanding degradation pathways
Session 2: Designing Stability Studies
- Setting acceptance criteria and study duration
- Sample selection and preparation
- Packaging and storage conditions
Session 3: Analytical Considerations in Stability Testing
- Selecting appropriate analytical methods
- Validating analytical methods for stability testing
- Statistical analysis of stability data
Day 2:
Session 4: Stability Challenges for ATMPs
- Unique challenges in stability testing for ATMPs
- Strategies for overcoming stability challenges in ATMPs
- Case studies and examples
Session 5: Stability Challenges for Drugs and Biologics
- Stability considerations for small molecules and biologics
- Common stability issues and challenges
- Case studies and examples
Session 6: Managing Stability Programs
- Stability data interpretation
- Changes to stability protocols and impact on stability data
- Stability reports and trending
The trainers for the Masterclass: CMC on Gene Therapy Products have a wealth of knowledge and expertise in the field of biopharmaceuticals. They have extensive experience in gene therapy product development and CMC, having worked with some of the leading companies in the industry. Their in-depth understanding of the regulatory landscape, coupled with their hands-on experience in the design, development, and commercialization of gene therapy products, provides an ideal opportunity for attendees to learn from the experts. The trainers will be available throughout the masterclass to answer questions, provide guidance, and share their insights with attendees.
The Stability Testing for ATMPs, Drugs, and Biologics masterclass is designed for professionals involved in the development, manufacturing, quality control, and regulatory affairs of pharmaceutical products. This includes:
- Scientists and researchers involved in drug discovery, development, and testing
- Quality control and assurance professionals responsible for ensuring product quality and stability
- Manufacturing personnel involved in production and processing of drug products
- Regulatory affairs professionals responsible for navigating complex regulatory environments and ensuring compliance with relevant guidelines and regulations.
This masterclass is also ideal for professionals looking to expand their knowledge and stay up-to-date with the latest stability testing techniques and regulations. Whether you are an industry veteran or new to the field, this course will provide you with the tools and knowledge you need to succeed in today’s competitive pharmaceutical industry.
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.