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Washington Marriott Hotel

Apr 15, 2013 8:30 AM - Apr 17, 2013 12:00 PM

1221 22nd Street NW, , Washington, DC 20037-1294 , USA

CMC Workshop: From Drug Development to Global Supply to Patients

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Session 3C: Clinical Trials in the European Union (Biologicals)

Session Chair(s)

Jilla Boulas, MS, MSc

Director

Voisin Consulting Life Sciences, United States

This session will focus on the EU guideline for CMC requirements for clinical trials for Biologicals, released in May 2012. Experiences and perspectives will be shared on the key elements when compiling and maintaining CMC documentation for investigational medicinal products. An update on the proposed EU Clinical Trials Regulation and its opportunities for the future and Biologicals in particular will also be discussed: simplified submission, authorization procedures, etc.

Speaker(s)

An Industry View Point On The CMC Requirements For Clinical Trials In The EU (Biotherapeutics)

Stefanie B. Pluschkell, PhD

Pfizer Inc, United States

Senior Director, Global Biotherapeutics, Policy and New Product Development

Khandan Baradaran, PhD

CMC Aspects Of Clinical Trial Applications: What The Regulators Ask - An Industry Perspective

Khandan Baradaran, PhD

Ultragenyx, United States

Vice President Regulatory CMC

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