Early clinical studies are critical steps in a drug development project. They must be designed to achieve regulatory compliance, but also to gain scientific knowledge regarding the drug target, mechanism of action, and viable biomarkers. Ultimately they should support proof-of-concept as early as possible.
What are the essential elements that must be considered when designing early clinical studies and how do you do it right first time?
Programme
Introduction by Anna T?rner
Business Director and Founder of SDS Life Science
Anna’s long and varied experience comes
from work within regulatory authorities, the pharmaceutical industry and academic research.
She has long-standing industry experience as a consultant within regulatory affairs and drug clinical trials at Zeneca Pharmaceuticals and others.
Her expertise lies within clinical development and she is particularly interested in merging statistical and regulatory knowledge to create studies better suited for regulatory needs.
Anna holds a MScs in Pharmacy and a MSc in Mathematical Statistics, and also a PhD in Medical Science from the Karolinska Institute in Stockholm.
Digital attendance
If you are unable to attend at 亚博娱乐官网_亚博pt手机客户端登录sparken, but will be able to attend digitally, please send an email to Torunn (t.v.espe@lifescience.uio.no