Day 1 - Thursday, May 7, 2020

7:30
Registration and Continental Breakfast
8:30
Co-Chair’s Opening Remarks
8:45

SUBMIT YOUR QUESTIONS

Town Hall on Policy and Legislation: Analyzing the Implications of Recent State and Federal Controlled Substance Initiatives
10:00
Morning Coffee Break
10:30
KEYNOTE TBA
11:15

STATE OF THE UNION PART I

An Assessment of the National Prescription Opiate Litigation
11:45

STATE OF THE UNION PART II

A Question of Responsibility: Understanding the Impact of the MDL settlement
12:45
Networking Luncheon
1:45

SUSPICIOUS ORDER MONITORING

Adjusting Your Compliance Program in View of New DEA Regulations
2:45

WAR ROOM ON PHARMACEUTICAL TAKE-BACK REQUIREMENTS

Devising Compliant and Efficient Strategies for Reverse Distribution and Waste Solutions
3:45
Afternoon Refreshment Break
4:00

DEA SITE VISIT CHECKLIST

Tailoring Inspection Strategies for Every Link of the Supply Chain
5:15
Conference Adjourns to Day Two

Day 2 - Friday, May 8, 2020

7:00
Continental Breakfast
8:00
Co-Chair’s Opening Remarks and Recap of Day One
8:15

THE FUTURE OF ANALGESIC APPROVALS

Incentives for New Therapeutics to Treat Pain and Addiction
9:15
Morning Coffee Break
9:30

DOJ KEYNOTE

Recent DOJ Civil and Criminal Enforcement Efforts
10:00
The Enforcers Speak: State and Federal Enforcement Initiatives
11:00

FDA KEYNOTE

Controlled Substances Initiatives for Cannabis, Opioids and New Drug Research
12:00
Networking Luncheon
1:15

THC V. CBD

Cannabis, Hemp and the Legal Status of Products Containing Cannabidiol (CBD)
2:15

NEW OBJECTS OF ADDICTION

Recognizing Dangerous Patterns for New Drugs of Concern
3:30

SUPPLY CHAIN CASE STUDY

DEA Due Diligence for Manufacturers, Distributors and Pharmacists
5:00
Conference Concludes

Day 1 - Thursday, May 7, 2020

7:30
Registration and Continental Breakfast
8:30
Co-Chair’s Opening Remarks
8:45

SUBMIT YOUR QUESTIONS

Town Hall on Policy and Legislation: Analyzing the Implications of Recent State and Federal Controlled Substance Initiatives

In this session, key stakeholders will provide you with insights into the current political and legislative landscaping in the controlled substances arena. Attendee questions submitted before the conference will be answered in real time in this town hall exchange.

Please submit your questions for consideration to conference producer Joseph Gallagher at [email protected]

  • Reviewing the status of DEA notices, FDA guidance, and the Trump Administration’s efforts to combat the opioid crisis
  • Evaluating the impact of the establishment and status of opioid task forces
    • Looking beyond opioids by examining other controlled substances of concern and the ramped up efforts to contain them
  • Analyzing proposed and pending legislation relative to controlled substances
  • Identifying legal and regulatory measures that are impacting health care professionals’ discretion and practice regimens
  • Understanding what each link of the pharmaceutical supply chain can do to promote collaboration and support in the industry in conjunction with government initiatives

10:00
Morning Coffee Break
10:30
KEYNOTE TBA
11:15

STATE OF THE UNION PART I

An Assessment of the National Prescription Opiate Litigation

At time of press, four attorneys general announced a proposed basis for a global settlement that may resolve actions brought against four of the five defendant companies involved in the opioid crisis under MDL #2804. A new trial date will be set for the remaining defendant company being sued for its role both as a distributor and a pharmacy.

This global settlement notwithstanding, the agreement does not end the larger looming legal war between local governments and defendant companies sued in federal courts. Thousands of suits are scheduled for subsequent trials without settlements being reached. With countless questions remaining, this prologue will provide context and background for the succeeding panel circumscribing the impact of these ever- unfolding developments.

11:45

STATE OF THE UNION PART II

A Question of Responsibility: Understanding the Impact of the MDL settlement

  • Prognosticating the economic, legal and compliance significances
  • Weighing predicted outcomes and reviewing the potential effects on the pharmaceutical business and compliance units
    • Implementing compliance procedures in advance of the decision
  • Understanding the implications of the Purdue Pharma bankruptcy and opioid settlement
  • Analyzing the findings from the Johnson & Johnson trial in Oklahoma and the implications for the opioid multidistrict litigation
  • Evaluating the arguments concerning false advertising and the consequences for manufacturers
  • Identifying the arguments surrounding diversion and the consequences for distributors

12:45
Networking Luncheon
1:45

SUSPICIOUS ORDER MONITORING

Adjusting Your Compliance Program in View of New DEA Regulations

  • Adapting your Suspicious Order Monitoring (SOM) program to answer to new regulation
  • Identifying suitable due diligence and “know your customer” actions
  • Understanding the strategy and operation of a suspicious order monitoring and reporting system
  • Executing support for ongoing employee training

2:45

WAR ROOM ON PHARMACEUTICAL TAKE-BACK REQUIREMENTS

Devising Compliant and Efficient Strategies for Reverse Distribution and Waste Solutions

  • Reviewing the EPA’s recently added regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors to ensure compliance
  • Analyzing risks, identifying liabilities, and evaluating cost when designing and implementing takeback compliance regimes
  • Understanding the implications of varying state laws requiring entities to pay for program implementation and disposal
  • Devising facility-specific strategies for take back and waste disposal programs
  • Ensuring your program is compliant, safe, and environmentally friendly

3:45
Afternoon Refreshment Break
4:00

DEA SITE VISIT CHECKLIST

Tailoring Inspection Strategies for Every Link of the Supply Chain

  • Evaluating established procedures for handling unannounced site visits for manufacturers, distributors and retail pharmacies
  • Analyzing the evolving state and federal regulations and concepts for bolstering compliance programs
  • Examining risk-management, inventory control concerns, record- keeping and security requirements to pass site visits and avoid unforeseen fines and/or federal charges
  • Identifying potential diversion risks to prevent diversion to protect patients, employees, and your organization during site visits

5:15
Conference Adjourns to Day Two

Day 2 - Friday, May 8, 2020

7:00
Continental Breakfast
8:00
Co-Chair’s Opening Remarks and Recap of Day One
8:15

THE FUTURE OF ANALGESIC APPROVALS

Incentives for New Therapeutics to Treat Pain and Addiction

  • Illustrating the FDA’s role in bringing innovative new drug therapies that are safe and effective to patients in need
  • Considering incentives for new therapeutics to treat pain and addiction
  • Overcoming barriers to innovation and assessing the value of novel analgesics
  • Evaluating abuse deterrence and other innovative approaches to address the prescription opioid epidemic

9:15
Morning Coffee Break
9:30

DOJ KEYNOTE

Recent DOJ Civil and Criminal Enforcement Efforts
10:00
The Enforcers Speak: State and Federal Enforcement Initiatives

This roundtable panel will provide 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 and the criteria for when DEA can issue immediate suspension orders.

11:00

FDA KEYNOTE

Controlled Substances Initiatives for Cannabis, Opioids and New Drug Research
12:00
Networking Luncheon
1:15

THC V. CBD

Cannabis, Hemp and the Legal Status of Products Containing Cannabidiol (CBD)

THC is currently illegal under federal law. Whether the federal government should regulate state marijuana programs continues to be disputed on the national stage. With the rise of vaping-related lung injuries and CBD oil flooding the market, the call for a reform of federal drug scheduling laws are quickly moving to the top of the regulatory agenda.

  • Analyzing the recent scheduling change of CBD in the wake of the DEA’s schedule I classification of the epilepsy medication Epidiolex
  • Reviewing the status of hemp, marijuana, and other cannabinoids under current federal law
    • Distinguishing “hemp-derived” from “marijuana-derived”
  • Navigating the legal pathways for bringing cannabinoids to market
  • Considering the evolving development of state cannabis laws
  • Understanding the emergence of cannabidiol and its future in the controlled substance arena
  • Complying with state storage and record keeping laws

2:15

NEW OBJECTS OF ADDICTION

Recognizing Dangerous Patterns for New Drugs of Concern

  • Analyzing the addictive potential of drugs of concern like gabapentin
  • Reviewing various state efforts to combat the opioid epidemic by modifying existing laws to categorize drugs as a non-opioid controlled substance
  • Recognizing the abuse potential and abuse liability of non-opioid medicines
  • Understanding the associated re-training requirements and licensing protocols for prescribers and dispensers and how states expect pharmacists to deal with re-scheduled, non-opioid controlled substances

3:30

SUPPLY CHAIN CASE STUDY

DEA Due Diligence for Manufacturers, Distributors and Pharmacists

Whether you’re a manufacturer, distributor, health care provider, or pharmacy, the best defense against a DEA enforcement action is a meticulous, considerate, and comprehensive compliance program tailored to your business needs. This interactive case study will use a hypothetical scenario implicating three major links in the supply chain in order to identify common risks and provide you with concrete solutions.

5:00
Conference Concludes

WORKSHOP A: Controlled Substances Bootcamp: An Introduction to Key Agencies, Regulation, and Scheduling

May 6, 2020 9:00am – 12:30pm

What is it about?

This bootcamp will provide an outline for the evolving regulations and compliance requirements for controlled substances to protect your company from unwanted investigations. Leading industry stakeholders will cover the ins and outs of the challenges that arise when working with controlled substances. Topics to be discussed include:

  • An introduction to the DEA and FDA: agency missions and organizational structures relative to controlled substance regulation
  • Understanding the intersection between FDA and the DEA jurisdiction over controlled substances
  • Defining a “controlled substance”
    • Understanding drug scheduling and the potential for abuse, safety, addictive potential and whether it has any legitimate medical applications
    • Considering the process to obtain approval from the DEA for schedule I-V controlled substances
    • Understanding abuse-deterrence, its current status, and its effect on the approval process
    • Working effectively with the DEA and FDA
    • Exploring the interplay between state licensing and federal regulations as they impact the discovery, development and marketing of controlled substances
    • Responding to DEA enforcement actions

WORKSHOP B: Compliance Think Tank: Building and Enhancing an Effective Controlled Substances Compliance Program

May 6, 2020 1:30pm – 5:00pm

What is it about?

In this compliance think tank, our controlled substance thought leaders will help you design a comprehensive handbook detailing the latest regulatory developments influencing risk management to maintain compliance and avoid unforeseen fines and/or federal charges. Topics to be discussed include:

  • Examining your existing controlled substances compliance program and identifying any gaps in relation to new regulation
  • Conducting internal audits of your facility and controlled substance inventory to ensure preparedness
  • Understanding your data and expected trends
  • Knowing what to do when you discover noticeable volume changes
  • Utilizing your data to prophylactically identify highest risks
  • Developing monitoring protocols and strengthening internal controls
  • Completing an appropriate biennial inventory of all Schedule II-IV controlled substances
  • Improving theft and loss reporting requirements
  • Ensuring proper whistleblower policies for your program