Academy

Good Manufacturing Practices (GMP): Training on regulatory requirements and best practices for ensuring product quality and safety in compliance with international standards.

Regulatory frameworks: Comprehensive guidance on navigating the complex regulatory landscapes specific to experimental medicinal products, including clinical trial authorisations and ATMP-specific guidelines.

Quality by Design (QbD): Principles and tools for integrating QbD into the development process to achieve consistent quality, reduce variability, and enhance scalability.

Risk management: Strategies to identify, assess, and mitigate risks in the development and manufacturing of experimental medicinal products.

Process development and scale-up: Practical insights into optimising manufacturing processes for biologicals and ATMPs, including considerations for scalability, robustness, and cost-effectiveness.

Sterility assurance and contamination control: Best practices for maintaining aseptic conditions and minimising contamination risks during product development and manufacturing.

Cell and gene therapy manufacturing: Specialised knowledge in handling, processing, and quality control of cell-based and gene-editing therapies, addressing their unique challenges and regulatory requirements.

Analytical methods development and validation: In-depth training on designing, optimising, and validating methods to assess product quality, potency, and safety, ensuring compliance with regulatory expectations.