Category 1 Focus Group

PART OF CROSS COMPANY ABUSE LIABILITY COUNCIL (CCALC)

 

ABOUT THE GROUP

The Category focus group was formed in spring 2015

 

Founder of the Cat 1 focus group and Member of the board of the Cross Company Abuse Liability Council (CCALC)

Karsten Lindhardt, Ph.D MSc DBE

CSO at Egalet Cooperation.

 

Steering Committee Members

Karsten Lindhart, Egalet Corporation

Sebastian Schwier, Grünenthal

Torben Elhauge, Egalet Corporation

Christopher Altomare, DrugScan

Robert Bianchi, Prescription Drug Research Center

Beatrice Setnik, Syneos Health

Stephen Hoag, University of Maryland

 

Focus Group Charter

• To share experiences and best practices in in vitro (Category 1) assessments of abuse deterrent formulations

• To discuss standardization of in vitro (Category 1) studies and limits associated with established standard practices

• To provide an open forum for discussion on the FDA Guidance for Industry: Abuse Deterrent Opioids – Evaluation and Labeling

• To provide an opportunity for presentations by academia, regulatory and industry experts focused on Category 1 studie

If you have questions, please contact

Torben Elhauge

Egalet CoRperation

telhauGE@egalet.com