This event will provide essential perspectives from both industry, regulatory and scientific perspectives in terms of what are the factors preventing biologics from progressing further in development and the vital elements of a successful early stage strategy for biologic studies.
Attendees will achieve an advanced understanding of how to incorporate the specific biologic requirements into the strategic & operational planning for an early phase clinical trial that provides the best opportunity to save time, reduce risk, reduce costs and maximise product value.
* Meet experts directly involved in biologic trial design and implementation
* Learn about the specific regulatory guidance and level of proof required to satisfy the governing bodies.
* Understand the perspectives of all stakeholder involved, i.e. regulators, sponsors, CROs, SMOs, central labs and experienced biologic investigators.
* Come to benchmark, share experience and help to develop a best-practice approach to biologic clinical development.
* Build stronger relationships upon a better understanding of the challenges faced by each group, who are all vital to the planning and implementation of the study
Who will benefit
* Experienced executives from Pharma and Biotechs involved in Biologic development
* VPs, Professors, Senior Directors and Managers
* Pre-Clinical Development
* Exploratory development
* Early phase clinical development
* Clinical science
* Clinical Operations
* Clinical pharmacology
* PK & PD
* Drug safety & biomarkers
* Translational medicine
* Regulatory affairs
To request the full agenda please follow the link:
For Booking Information:
Tel: +421 232 662 621
Fax: +421 232 662 622