Strategies and Considerations from Discovery to Clinic
Join us at CATALENT – NLSDAYS PRE-EVENT to listen to Gunnar Danielsson, our Senior Regulatory Advisor who will be taking the audience through an overview of Phase 1 study protocol designs and goals, How to initiate a Phase 1 study followed by the Importance of pharmacokinetics, achieving max tolerated dose and establishing therapeutic index in the first part of the event. After coffee, he will talk again to present CRO coordination, how to run complex trials followed by clear guidance with regulatory submissions.
Gunnar Danielsson is a former GCP inspector and has traveled around the world performing GCP inspections for the Swedish Medical Product Agency for over 10 years. He has 40 years’ experience in Clinical Research and has a wealth of experience from the Pharmaceutical industry in terms of quality management, electronic systems, data management, and clinical design and conduct. Gunnar today is a key advisory resource and helps to design studies in the most effective way, meeting regulatory requirements.
See full agenda here: https://www.catalentmalmo.com/agenda