Work session

5 Junho 2026, 17:00 • Rudi Micael Santiago de Oliveira

In this final class a case study is presented showcasing one of the possible approaches to look at an early stage chemical process and define the process development workload meant to bring that process to large scale. This will touch base in each of the topics lectured during the classes. In the end the students will have time to start preparing their assays.

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Wrap-up & Q&A

29 Maio 2026, 17:00 • Rudi Micael Santiago de Oliveira

The final class is meant to go high level through the various topics presented in the course and how they come together in the effort to develop a chemical process in the pharmaceutical industry. This is the opportunity for the students to ask questions and consolidate the learnings to organize their work for the course evaluation.

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Regulatory Affairs

22 Maio 2026, 17:00 • Rudi Micael Santiago de Oliveira

This calls covers the intense field of Regulatory Affairs in the pharmaceutical industry, mostly inclined to topics around drug substance. Concepts around GMP and ICH guidelines are important for anyone who later intends to work in the pharmaceutical industry.

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Quality by Design & Risk Assessment

15 Maio 2026, 17:00 • Rudi Micael Santiago de Oliveira

Here the students will understand the important concepts that are required to demonstrate a process was development with Quality and Robustness in mind, in a way that allows a team to design an adequate control strategy to ensure a process runs at scale as intended.

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Modeling & Simulation

8 Maio 2026, 17:00 • Rudi Micael Santiago de Oliveira

This class covers commonly used modeling tools that support process chemistry development. Examples are given for the various unit operations. The impact of modeling and simulation goes beyond saving time in the lab, it also contributes to higher process understanding which adds value when scaling up processes

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