This course will encourage the adoption and the utilisation of the full extent of the current regulatory guidance and share practical examples as to how to achieve.
This course helps participants understand how AI can support PV work while maintaining regulatory compliance, patient safety, data integrity and inspection readiness.
This intensive two-day course provides a practical, end-to-end framework for developing combination products from early strategy through design controls, regulatory submission, approval, and lifecycle management.
This three-tiered course provides a strong foundation in core toxicology and regulatory expectations as well as critical insights into NAMs and MPS for earlier mechanistic insights.
Practical R&D Decision Analysis for Pharma & Biotech
27 - 29 October 2026
Online Live Stream | 13:30 CET - 17:30 CET / 08:30 EDT - 12:30 EDT
The course focuses on how decision analysis is adapted and applied in real drug development organizations, where decisions must be made under uncertainty, with incomplete data, evolving strategies, and strong organizational constraints.
The purpose of this Stability & Shelf Life of Biologics Training Course is to get comprehensive overview on stability and shelf-life regulatory landscape.
3 - 4 November 2026 5th November 2026 | Site Visit to Optima Pharma (Participation is by invitation only.)
Frankfurt, Germany
This practical course will focus on the freeze-drying process from formulation and thermal analysis to cycle development and optimization, packaging and troubleshooting.
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