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Thursday, February 7 • 12:00 - 13:15
#S0907: ICH Info Day – Part 2

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Component Type: Session

Part 2 of the ICH Info Day focuses on the Safety guideline S1 on criteria for when to conduct rodent carcinogenicity studies and on the Efficacy guideline E8 as the first step towards the GCP renovation initiated in 2017.

Chair

Pär Tellner, MSc

Speaker

Introduction
Pär Tellner, MSc

Carcinogenicity Studies S1
Tania Cecilia Cavaliero, DVM

General Considerations for Clinical Trials E8 (GCP Renovation)
Fergus Sweeney, PhD



Speakers
avatar for Tania Cecilia Cavaliero

Tania Cecilia Cavaliero

Preclinical Assessor, Swissmedic
Tania Cavaliero is Preclinical Assessor at Swissmedic since 2010. Before this role, she worked in research, early development and project management in the animal health pharmaceutical industry. She is member of the ICH S1 (R1) expert working group.
avatar for Fergus Sweeney

Fergus Sweeney

Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, Netherlands
Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing... Read More →
avatar for Pär Tellner

Pär Tellner

EFPIA ICH Coordinator, Director Regulatory Affairs, EFPIA
Pär Tellner is Director EFPIA since 2012 and member of ICH Management Committee and Assembly since 2016. Pär has previously been working as Compliance officer (marketing ethics) and Director of Veterinary Medicine, LIF Sweden and as Head of regulatory affairs for several pharmaceutical... Read More →


Thursday February 7, 2019 12:00 - 13:15 CET
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria