What you will learn
- The purpose of each category of the non-clinical safety studies needed to support clinical development of Pharmaceuticals
- How to select the right studies at the right time to meet the company’s needs and regulatory requirements and how to evaluate the results and find the predictive value of them
- How to put together the non-clinical part of a registration dossier
- How to analyze non-clinical requirements for specific types of medicine, clinical indications and implications in relation to the composition and conduct of the non-clinical safety study programme
- Best practices when interacting with non-clinical specialists as well as with clinicians, CMC specialists and the regulatory agencies in order to ensure that non-clinical safety information is generated, interpreted and communicated correctly to the benefit of patient safety
What your company will get
- A regulatory professional who understands the purpose of each category of the non-clinical safety studies needed to support clinical development of Pharmaceuticals
- A regulatory affairs professional who is able to analyze non-clinical requirements for specific types of medicines and thereby contribute to the composition and conduct of the non-clinical safety study programme from a regulatory point of view
- A regulatory affairs professional who is able to interact with non-clinical specialists and regulatory agencies to ensure that non-clinical safety information is generated, interpreted and communicated correctly