What you will learn
- The basic principles of manufacturing biopharmaceuticals — from the recombinant starting material to the final product
- How to evaluate and organize information provided by CMC/quality stakeholders during product development and post-approval
- How to prepare regulatory CMC/quality strategies considering both FDA and EU aspects throughout clinical development and how to evaluate relevant regulations and guidelines for biopharmaceuticals
- How to use best practice in product characterization and how to set the release and stability specifications of a biopharmaceutical
What your company will get
- A regulatory professional who understands the basic principles of manufacturing biopharmaceuticals
- A regulatory affairs professional who is able to evaluate and organize the information and documentation provided by CMC/Quality stakeholders, challenge it and ask the right questions
- A regulatory affairs professional who is able to prepare regulatory CMC/Quality strategies considering both FDA and EU aspects