Agenda

8:00 - 8:40 AM
Registration and Continental Breakfast


8:40 - 8:45 AM
FDLI Welcome

Susan C. Winckler, RPh, President & CEO, FDLI


8:45 - 10:15 AM
DEA and FDA Regulation of Controlled Substances: A Review of 2013, What to Expect in 2014
Panelists will review regulatory developments from 2013 and provide an update on what to expect in the coming year. Panelists will address topics, including scheduling delay issues, Abuse deterrent formulations, Hydrocodone re-scheduling, Risk Evaluation and Mitigation Strategies (REMS) for controlled substances.

Douglas C. Throckmorton, M.D., Deputy Director, CDER, FDA | Slides

Moderated by Lynn Mehler, Partner, Hogan Lovells LLP


10:15 - 10:30 AM
Networking Break


10:30 AM - 12:30 PM
Scheduling: A Roundtable on Challenges and Opportunities
A discussion of important scheduling and re-scheduling actions from the past year, with a focus on challenges and opportunities in 2014.

Jack Henningfield, Vice President, Research & Health Policy, Pinney Associates Inc. | Slides
Michael Klein, Ph.D., Director, Controlled Substance Staff, CDER, OCD, FDA | Slides
Andrea C. Masciale, Vice President, Regulatory Affairs, Johnson & Johnson | Slides
Angela M. Ostrom, Esq., Vice President Public Policy & Advocacy, Epilepsy Foundation | Slides

Moderated by Ginny Beakes- Read, Executive Director, Global Regulatory Policy and Intelligence, Global Regulatory Affairs, Eisai, Inc. | Slides


12:30 - 2:00 PM
Luncheon Speaker

Andrea G. Barthwell, M.D., FASAM, CEO, Encounter Medical Group and Director, Two Dreams | Slides


2:00 - 3:15 PM
Litigation and Enforcement Update
This session will review significant enforcement actions from the past year and related litigation with a look ahead to 2014.

Jodi Avergun, Partner, Cadwalader, Wickersham & Taft LLP | Slides
Linden Barber, Director of DEA Compliance Operations, Quarles & Brady LLP |Slides

Moderated by John Gilbert, Director, Hyman, Phelps & McNamara, P.C. | Slides

3:15 - 3:30 PM
Networking Break


3:30 - 4:45 PM
Hot Topics in Enforcement: Suspicious Order Monitoring

Ronald W. Buzzeo, RPh, Chief Compliance Officer, Cegedim | Slides
John J. Coleman, PhD, Retired Assistant Administrator, U.S. Drug Enforcement Administration | Slides
Maureen O'Keefe, Retired, Associate Section Chief, U.S. Drug Enforcement Administration, Office of Diversion Control, Synthetic Drugs and Chemicals Section | Slides
Brian Reise,Consultant, Controlled Pharmaceutical Consultants, Inc. | Slides

Moderated by John Gilbert, Director, Hyman, Phelps & McNamara P.C.| Slides


4:45 PM
Adjournment