Introduction to Clinical Development

SUMMARY

On this two day course, you get an overview of and insight into the considerations and decisions that lie behind the successful development of new medicines.

The course is taught by an extensive team of experienced experts, who, among other topics, teaches you how to select the right molecules and what the purpose and content of the clinical development phases (I-III) are.

You also learn how a clinical development plan is developed, including the regulatory requirements that must be met, such as the benefit-risk balance within a specific disease area.

A key parameter for success is collaboration with other stakeholders, and on the course, you also learn how to establish good collaboration between Clinical Development and Clinical Operation – and how to communicate with authorities, e.g. about clinical data and its value.

After the course, you will also know about the increasingly central role that Real World Evidence plays, as well as how clinical development will take place in the future. 

Other course participants say

 “I think it was valuable to get a better understanding of the different areas within clinical trials. The presenters were great.” 

Marie Engelbrecht, CTA, Novo Nordisk A/S

Keywords

• Clinical development plans
• Clinical trials phases (I-III)
• Study design and use of clinical data
• Statistic and data management
• Pharmacovigilance