Successfully starting your clinical development: Regulatory and business perspectives

Agenda

09.45 – 10.00
Welcome Coffee & Registration

10.00 – 10.10
PAREXEL Welcome & Introduction

10.10 – 10.50
Risk assessment for first in human studies – an investigator’s perspective (Matthias Grossmann)

10.50 – 11.30
Quantitative clinical development for first in human studies (Laura Iavarone and Silvia Maria Lavezzi)

11.30 - 11.50
Coffee break

11.50 - 12.30
CMC requirements, expectations of the regulatory authorities and what to avoid – focus on biologics (Keith Chidwick)

12.30 - 13.15
Networking Lunch

13.15 - 14.00
Global expedited regulatory pathways and EU scientific advice (Bridget Heelan)

14.00 – 14.45
What a potential pharma licensing partner is looking for (Olaf Ritzeler in Heidelberg and Dmitrij Hristodorov in Berlin)

14.45 – 15.00
Closing remarks

Registration: Martina.Docherty@parexel.com