Agenda
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Pre-Conference Workshop
Pre-Conference Workshop A: Controlled Substances Boot Camp: Introduction To The Fundamentals
Jan 29, 2018 2:00pm – 5:00pm
Speakers
Ronald W. Chapman, II
Shareholder
Chapman Law Group (Troy, MI)
Dominic Chiapperino
Acting Director Controlled Substance Staff Center for Drug Evaluation and Research
Food and Drug Administration
Robert N. Nicholson
Partner
Nicholson & Eastin LLP (Fort Lauderdale, FL)
Day 1 - Tuesday, January 30, 2018
7:45 |
Registration and Continental Breakfast |
8:45 |
Co-Chairs’ Opening remarks |
9:15 |
Politics and Policy of Controlled Substances in View of the Opioid Overdose Crisis |
11:00 |
Networking Break |
11:30 |
Reassessing your Responsibilities in Light of the Changing Scope of Suspicious Order Monitoring Requirements |
12:30 |
Networking Luncheon |
1:45 |
Understanding and Comparing State Prescription Drug Monitoring Programs |
2:45 |
Evolution of Abuse-Deterrent Opioid Drug Products |
3:45 |
Networking Break |
4:00 |
Overcoming Challenges for Schedule III Opioids and Non-Opioid Products |
4:30 |
New Chemical Entities (NCEs) |
5:00 |
Conference Adjourns to Day 2 |
Day 2 - Wednesday, January 31, 2018
12:45 |
Networking Luncheon for Workshop Participants |
7:45 |
Continental Breakfast |
8:15 |
Co-Chairs’ Welcome and Recap of Day 1 |
8:30 |
Diving into the State, County, and City Opioid-Related Investigations |
9:30 |
Update on State and Federal Enforcement Initiatives |
11:00 |
Networking Break |
11:15 |
Cracking the Code on DEA Pharmaceutical Take Back Programs |
12:00 |
Tomorrow’s Headlines: Litigations, Task Forces, and New Technologies |
Post-Conference Workshop
Post-Conference Workshop B: Simulated Dea Inspection Exercise: Is Your Facility Ready ?
Jan 31, 2018 2:00pm – 5:00pm
Speakers
Benjamin Mink
Director of Compliance and Security
Miami Luken (Springboro, OH)
Brian Rucker
Former DEA Supervisory Diversion Investigator
Director of Compliance
Independent Pharmacy Cooperative (Phoenix, AZ)
Jack Teitelman
President Titan Group (New York, NY)
Former New York Division Security Special Agent U.S. Dept. of Justice-Drug Enforcement Administration
Day 1 - Tuesday, January 30, 2018
7:45 |
Registration and Continental Breakfast |
8:45 |
Co-Chairs’ Opening remarksLarry P. Cote Christina M. Markus |
9:15 |
Politics and Policy of Controlled Substances in View of the Opioid Overdose CrisisJames Arnold Michael Klein, Ph.D. Louis Milione Shruti Kulkarni Moderator:John A. Gilbert Jr. Our nation is in trouble. Preliminary New York Times data shows that between 59,000-65,000 people died from drug overdoses in 2016, and the death toll continues to rise in 2017. This roundtable session will bring together key policy leaders from industry organizations to provide their input as to how our nation got here, current initiatives, recent and pending legislation, DEA notices and FDA Guidances, REMs updates, patient access, and other happenings on the Hill. Our panelists will discuss their best options for the future and for ending the opioid overdose epidemic. |
11:00 |
Networking Break |
11:30 |
Reassessing your Responsibilities in Light of the Changing Scope of Suspicious Order Monitoring RequirementsJodi Avergun Louis Milione
|
12:30 |
Networking Luncheon |
1:45 |
Understanding and Comparing State Prescription Drug Monitoring ProgramsErika Marshall Brian Rucker
|
2:45 |
Evolution of Abuse-Deterrent Opioid Drug ProductsMichael S. Labson Peter Mathers
|
3:45 |
Networking Break |
4:00 |
Overcoming Challenges for Schedule III Opioids and Non-Opioid ProductsJohn A. Gilbert Jr.
|
4:30 |
New Chemical Entities (NCEs)Christina M. Markus
|
5:00 |
Conference Adjourns to Day 2 |
Day 2 - Wednesday, January 31, 2018
12:45 |
Networking Luncheon for Workshop Participants |
7:45 |
Continental Breakfast |
8:15 |
Co-Chairs’ Welcome and Recap of Day 1 |
8:30 |
Diving into the State, County, and City Opioid-Related InvestigationsMeredith S. Auten Ann Callis Benjamin Goetten This session will provide a comprehensive overview of the ongoing state opioid-related enforcement cases. Our panelists will discuss the various causes of action, strategies, parties involved, as well as differences across cases. The panel will include an up-to-date status on the timelines of the cases, any related settlements, a multi-faceted presentation of one rural county’s legal journey in tackling the opioid overdose crisis, and the panelists insights into what lies in the future. |
9:30 |
Update on State and Federal Enforcement InitiativesJames Arnold Thomas Corcoran Larry P. Cote Amanda Rocque This roundtable panel provides our attendees with the unique opportunity to hear from state and federal government officials as well as enforcement experts as they discuss the ins and outs of the enforcement world including orders to show cause and remedial action plans, when DEA can issue immediate suspension orders, and more. |
11:00 |
Networking Break |
11:15 |
Cracking the Code on DEA Pharmaceutical Take Back ProgramsSelin Hoboy
|
12:00 |
Tomorrow’s Headlines: Litigations, Task Forces, and New TechnologiesJoshua G. Berman Jason Parish This session will initiate an open discussion among attendees into topics such as:
|
Pre-Conference Workshop A: Controlled Substances Boot Camp: Introduction To The Fundamentals
Ronald W. Chapman, II
Shareholder
Chapman Law Group (Troy, MI)
Dominic Chiapperino
Acting Director Controlled Substance Staff Center for Drug Evaluation and Research
Food and Drug Administration
Robert N. Nicholson
Partner
Nicholson & Eastin LLP (Fort Lauderdale, FL)
What is it about?
This workshop provides a basic overview of controlled substance regulations and prepares you for the more in-depth discussions that will take place throughout the main conference. This session will set the stage for the main conference by helping attendees thoroughly comprehend the structure of the DEA and FDA while walking through the evergreen and recent challenges that arise when working with controlled substances. Get the background you need to flow seamlessly into the more in-depth discussions that will take place during the main conference. Topics include:- Introduction to the DEA and FDA: agency missions and organizational structures
- History of controlled substances regulations
- Intersection between FDA and the DEA: how to work effectively with both agencies
- Overview of the drug scheduling process and its effects on approval
- How to de-schedule a drug or move to a different schedule
- Registration for a DEA number
- Understanding abuse-deterrence, its current status, and its effect on the approval process
- Responding to DEA enforcement actions
- State licensing and the interplay with federal regulations
- Advertising and promotion of controlled substances
Post-Conference Workshop B: Simulated Dea Inspection Exercise: Is Your Facility Ready ?
Benjamin Mink
Director of Compliance and Security
Miami Luken (Springboro, OH)
Brian Rucker
Former DEA Supervisory Diversion Investigator
Director of Compliance
Independent Pharmacy Cooperative (Phoenix, AZ)
Jack Teitelman
President Titan Group (New York, NY)
Former New York Division Security Special Agent U.S. Dept. of Justice-Drug Enforcement Administration
What is it about?
In this exercise, our DEA experts will walk attendees through a mock, unannounced DEA facility inspection and will present tips and best strategies for preparing for, completing a well-supported response, and minimizing/avoiding penalties. Our panelists will explore topics such as:- Evaluating internal procedures and how they fit with the ever-changing state and DEA requirements including: Standard Operating Procedure (SOP) Development, Customer Due Diligence/ “Know Your Customer” Activities, and Physical Security Best Practices
- Examining risk-management, inventory control issues, record-keeping and security issues, to maintain compliance and avoid unforeseen fines and/or federal charges.
- Identifying potential diversion risks and suggestions for improvement (i.e. dispensing data analysis, 21st century pharmaceutical site evaluations, prescriber due diligence, and information gathering tools/techniques)