Description
Regulatory and Industry Panel | The Regulatory and Industry Panel is one of the highlights of this conference. This session features questions and answers of the most daunting regulatory issues facing regulators and industry at this time. You will learn the most current perspectives of thought leaders regarding your most pressing challenges. The session is completely interactive, providing for a very rich experience. You will not want to miss this session.
Speaker(s):
- Alonza
Cruse,
Director, Office of Pharmaceutical Quality Operations,
FDA/ORA
- Jörg
Zimmermann,
Vice President, Vetter Development Service, External Affairs,
Vetter Pharma-Fertigung GmbH & Co.
Moderator(s):
- David
Doleski,
Compliance Head for Biologics Quality Operations,
Sanofi
Speaker(s):
- Thomas
J. Arista,
Consumer Safety Officer,
FDA/ORA
- Alonza
Cruse,
Director, Office of Pharmaceutical Quality Operations,
FDA/ORA
- Rick
Friedman,
Deputy Director, Office of Manufacturing Quality,
CDER/FDA
- Brooke
Higgins,
Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality,
FDA/CDER/OC/OMQ
- Alyce
Maksoud,
Senior GMP Inspector,
Australian Government Department of Health
- Alan
Moon,
Senior GMDP Inspector,
Medicines and Healthcare Products Regulatory Agency (MHRA)
- Robert
Sausville,
Director, Div. Case Management,
FDA/CBER/OMPT/OCBQ
