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Pre-Conference Workshops
Controlled Substances 101: Introduction to the Fundamentals
May 28, 2019 9:00am – 12:30pm
Speakers
Ronald Friedman
Counsel
Karr Tuttle Campbell (Seattle, WA)
Daniel Kracov
Partner
Arnold & Porter Kaye Scholer (Washington, DC)
Building And Enhancing Your Controlled Substances Compliance Program
May 28, 2019 1:30pm – 5:00pm
Speakers
Ronald Chapman
Shareholder
Chapman Law Group (Troy, MI)
Jodi Switalski
Founder and Chief Consultant
Switalski Law and Consulting (Huntington Woods, MI)
Day 1 - Wednesday, May 29, 2019
7:30 |
REGISTRATION AND CONTINENTAL BREAKFAST |
8:30 |
Co-Chairs’ Opening Remarks |
9:00 |
Understanding the Implications of the National Policy Response to the Opioid Overdose Crisis |
10:00 |
MORNING COFFEE BREAK |
10:30 |
Untangling the Intricacies of Suspicious Order Monitoring Requirements |
11:45 |
Analyzing the Verified Accredited Wholesale Distributor (VAWD) Certification and its Effects on Pricing and the Supply Chain |
12:45 |
NETWORKING LUNCHEON |
2:00 |
How the Uptick in Opioid Litigation is Affecting the Industry: Key Takeaways from the MDLs |
3:00 |
AFTERNOON REFRESHMENTS BREAK |
3:15 |
Deciphering Controlled Substance Disposal Requirements and Takeback Programs |
4:30 |
CONFERENCE ADJOURNS TO DAY 2 |
Day 2 - Thursday, May 30, 2019
7:45 |
CONTINENTAL BREAKFAST |
8:15 |
Co-Chairs’ Welcome and Recap of Day 1 |
8:30 |
When DEA Comes Knocking: Ensuring your Facility Successfully Passes Inspection |
10:00 |
MORNING COFFEE BREAK |
10:30 |
Dissecting DEA’s Quota Reduction Regulation |
11:30 |
Drug Scheduling and Shipments: A Practical Review of State Rules and Regulations |
12:15 |
NETWORKING LUNCHEON |
1:15 |
Spotlight on New Jersey’s Opioid Abuse Prevention and Enforcement Unit |
1:45 |
Keeping up and Complying with Evolving State Prescription Drug Monitoring Programs |
2:45 |
AFTERNOON REFRESHMENT BREAK |
3:00 |
Inside Perspectives on Federal and State Government Trends in Opioid Enforcement |
4:30 |
CONFERENCE ENDS |
Day 1 - Wednesday, May 29, 2019
7:30 |
REGISTRATION AND CONTINENTAL BREAKFAST |
8:30 |
Co-Chairs’ Opening RemarksRichard Hartunian Lynn Mehler |
9:00 |
Understanding the Implications of the National Policy Response to the Opioid Overdose CrisisShruti Kulkarni Seth Mailhot Over the past year, President Trump has initiated various actions in the fight against the opioid overdose crisis. Recently, the President called on Attorney General Sessions to initiate a federal law suit against the drug companies, paralleling the current multidistrict and standalone state-level litigations. Our panel of policy experts will address these actions and other relevant developments on the Hill and their insights into closing the door on this crisis. Topics of discussion include:
|
10:00 |
MORNING COFFEE BREAK |
10:30 |
Untangling the Intricacies of Suspicious Order Monitoring RequirementsCathy Gallagher
|
11:45 |
Analyzing the Verified Accredited Wholesale Distributor (VAWD) Certification and its Effects on Pricing and the Supply ChainSumeet Singh
|
12:45 |
NETWORKING LUNCHEON |
2:00 |
How the Uptick in Opioid Litigation is Affecting the Industry: Key Takeaways from the MDLsJason Parish Edward Rickert In the year that has passed since our inaugural event, the Judicial Panel on Multidistrict Litigation has centralized more than 1100 opioid-related lawsuits in the Northern District of Ohio- National Prescription Opiate Litigation, MDL #2804. The DOJ has joined the case as a “friend of the court” to assist with settlement negotiations. Presently, the MDL trial is set for September 2019, with ongoing potential settlement discussions. In this session, our panelists will take a deep dive into the MDL as well as similar proceedings such as the Native American Tribe suits and the Texas counties MDL. Our speakers will provide a thorough analysis of how the outcomes of these cases will affect your business and manufacturing practices. Topics of discussion include:
|
3:00 |
AFTERNOON REFRESHMENTS BREAK |
3:15 |
Deciphering Controlled Substance Disposal Requirements and Takeback ProgramsHilary Bowman
|
4:30 |
CONFERENCE ADJOURNS TO DAY 2 |
Day 2 - Thursday, May 30, 2019
7:45 |
CONTINENTAL BREAKFAST |
8:15 |
Co-Chairs’ Welcome and Recap of Day 1 |
8:30 |
When DEA Comes Knocking: Ensuring your Facility Successfully Passes InspectionAntonio Pozos Brian Rucker Join our team of veteran investigators for this interactive mock DEA facility walkthrough. Our speakers will take you on an interactive journey through several real-life situations and will provide you with tools you can immediately incorporate into your facility programs. Topics of discussion will include:
|
10:00 |
MORNING COFFEE BREAK |
10:30 |
Dissecting DEA’s Quota Reduction RegulationKaren Owen Gibbs Lynn Mehler DEA’s final Controlled Substances Quota Regulation is in effect as of August 15th, 2018. Take a seat as Ms.Harper-Avilla discusses the ins and outs of the regulation. Learn how to assess your internal policies and make the proper adjustments to your business practices to minimize the impact to your company. |
11:30 |
Drug Scheduling and Shipments: A Practical Review of State Rules and RegulationsChristina Markus
|
12:15 |
NETWORKING LUNCHEON |
1:15 |
Spotlight on New Jersey’s Opioid Abuse Prevention and Enforcement UnitErica Liu |
1:45 |
Keeping up and Complying with Evolving State Prescription Drug Monitoring ProgramsRonald Chapman Amanda Glover, Pharm.D.
|
2:45 |
AFTERNOON REFRESHMENT BREAK |
3:00 |
Inside Perspectives on Federal and State Government Trends in Opioid EnforcementRichard Hartunian John Kelly Erica Liu Elliot M. Schachner Join our stellar group of current and former government enforcement leaders as they dive into the most recent opioid enforcement actions and initiatives. This unique panel will provide their unique insights on:
|
4:30 |
CONFERENCE ENDS |
Controlled Substances 101: Introduction to the Fundamentals
Ronald Friedman
Counsel
Karr Tuttle Campbell (Seattle, WA)
Daniel Kracov
Partner
Arnold & Porter Kaye Scholer (Washington, DC)
What is it about?
This workshop provides a basic overview of controlled substance regulations and will set the stage for the main conference by helping attendees thoroughly comprehend the structure and authority of the DEA and FDA in this area while walking through the evergreen and recent challenges that arise when working with controlled substances. Get the background information 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, authority and organizational structures
- History of controlled substances regulations
- Intersection between FDA and the DEA: how to work effectively with both agencies
- Reviewing the drug scheduling process and effects on approval
- How to de-schedule a drug or move to a different schedule
- Applying for a schedule I license, including for research purposes
- Registration requirements for a DEA number and DEA X number
- Understanding abuse-deterrence, its current status, and its effect on the approval process
- Responding to DEA audits, investigations, and enforcement actions
- State licensing and the interplay with federal regulations
- Advertising and promotion of controlled substances
Building And Enhancing Your Controlled Substances Compliance Program
Ronald Chapman
Shareholder
Chapman Law Group (Troy, MI)
Jodi Switalski
Founder and Chief Consultant
Switalski Law and Consulting (Huntington Woods, MI)
What is it about?
(Registration begins at 1:00 pm)
In this targeted session, our compliance experts will provide you with an extensive analysis of tried and true methods for strengthening your internal controlled substance compliance programs. Attend this one-of-a-kind workshop and walk away with tools you can immediately incorporate into your workplace. The indepth discussion will provide ways to address the biggest compliance-related challenges including:- Conducting internal audits of your facility and controlled substance inventory
- Understanding your data and expected trends
- Knowing what to do when you discover noticeable volume changes
- Utilizing your data to prophylactically identify highest risks
- Monitoring and internal controls
- Completing an appropriate biennial inventory of all Schedule II-IV controlled substances
- Ensuring proper whistleblower policies for your program
- Improving theft and loss reporting requirements