6th Annual Summit on Controlled Substances - WEB

March 14–15, 2023 | Washington, DC

6th Annual Summit on CONTROLLED SUBSTANCES

REGULATION, LITIGATION, AND ENFORCEMENT

Reconnect in-person with industry peers, key industry stakeholders from the controlled substances supply chain, and government officials, including leaders from DEA, DOJ and FDA, as we examine the latest regulatory and legal developments and trends impacting these products.

Distinguished Co-Chairs:

Jolie Apicella Partner Wiggin & Dana LLP

Gustav Eyler Partner Gibson, Dunn, & Crutcher LLP

Cori Rizman Director, Compliance –Controlled Substances Oversight Region North America

Fresenius-Kabi USA

Former Diversion Investigator/Supervisor, DEA

Exclusive Keynotes from DOJ, and FDA:

Amanda Liskamm Director, Consumer Protection Branch

U.S. Department of Justice

Dominic Chiapperino, Ph.D. Director, Controlled Substance Staff Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Industry thought leaders will help you:

ĉ ASSESS the current status of the National Opioid Litigation and MDL Settlements

ĉ ANALYZE the therapeutic potential of marijuana and psychedelics

ĉ EVALUATE the role of Telemedicine in controlled substances prescribing, distribution, and abuse

ĉ DEVELOP a comprehensive Controlled Substances Compliance Program

ĉ RESPOND effectively to DEA and FDA investigations

SPONSOR:

American Conference Institute invites you to join our 6th Annual Summit on Controlled Substances: Regulation, Litigation, and Enforcement

Over the past year, opioid-related enforcement remained a top federal and state priority, as seen through the record recoveries under the False Claims Act and the multi-district litigation against major manufacturers, distributors and pharmacies. Opioid-related enforcement continues to be a top government priority, especially due to the correlated increase in overdoses from the use of counterfeit pills that contain fentanyl.

However, opioids are not the only controlled substance on the governments’ radar: the increased use of telemedicine for the prescription of controlled substances during the COVID-19 pandemic has influenced a surge in prescriptions for amphetamines, such as Adderall, for the treatment of ADHD.

Futhermore, in October 2022, the Biden Administration announced that it would begin pardoning all prior offences of simple possession of marijuana and asked that DEA and FDA begin the administrative process to review how marijuana is scheduled under federal law. In the near future, we may see new therapeutics involving THC, and lessons can be learned from the existing hemp, recreational, and medical marijuana industries. Equally, the pharmaceutical industry is on the cusp of an emerging paradigm in therapeutics: psychedelics. Impressive breakthroughs in clinical trials frequently make headlines as states continue to legalize the use of psychedelics.

The world of controlled substances enforcement, regulation and litigation is evolving, and the benefits of innovation must be carefully balanced against the risks and costs of non-compliance.

This March, connect with government officials and key industry stakeholders from throughout the controlled substances supply chain to examine the latest legal and regulatory developments impacting the industry. Attend and learn how to best conform business practices to meet growing regulatory demands, bolster compliance programs, mitigate risk, and reduce liability. Be part of the only conference that presents strategies and solutions for every link of the controlled substances supply chain.

Who Should Attend?

• Compliance officers

• Chief quality officers

• Presidents/CEOs

• Senior internal auditors

• Directors of compliance

• Regulatory/risk officers

• Government employees

• Pharmacists

• General counsel

• Compliance, regulatory and litigation attorneys

EARN CLE CREDITS

Continuing Legal Education Credits

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

Distinguished Faculty

Co-Chairs

Jolie Apicella Partner

Wiggin & Dana LLP

Former AUSA, Chief of Healthcare Fraud, Eastern District of New York

Government

Dominic Chiapperino, Ph.D. Director, Controlled Substance Staff Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Scott B. Dahlquist Opioid Coordinator, Consumer Protection Branch U.S. Department of Justice

Matthew Feeley Deputy Chief & Healthcare Fraud Coordinator, USAO SDFL Civil Division U.S. Department of Justice

Industry Executives

William Chang Chief Legal Officer, Corporate Secretary UpStream Healthcare

Janet Hart Director, Government Affairs Rite Aid

Law Firm Attorneys

Nathan A. Beaver Partner Foley & Lardner LLP

Joseph J. Bogdan Founding Lawyer The Law Offices of Joseph J. Bogdan, LLC

Ronald Chapman President Chapman Consulting Group

Kimberly I. Chew Partner Husch Blackwell LLP

Gustav Eyler Partner

Gibson, Dunn, & Crutcher LLP

Former Director of Consumer Protection Branch, U.S. Department of Justice

Francis Godwin Director, Office of Manufacturing Quality U.S. Food and Drug Administration

Monica Hanna Special Counsel Office of the NY State Attorney General

Jonathan Lenzner Chief of Staff Federal Bureau of Investigations

Amanda Liskamm Director, Consumer Protection Branch U.S. Department of Justice

Lisa Miller Deputy Assistant Attorney General | Fraud and Appellate Sections

U.S. Department of Justice, Criminal Division

Anthony J. Nardozzi Assistant Director U.S. Department of Justice, Consumer Protection Branch, Civil Division

Arun Rao Deputy Assistant Attorney General U.S. Department of Justice, Civil Division

Cori Rizman Director, Compliance –Controlled Substances Oversight Region North America Fresenius-Kabi USA

Former Diversion Investigator/ Supervisor, DEA

Gabriel H. Scannapieco Assistant Director, Consumer Protection Branch U.S. Department of Justice

Elliot Schachner Assistant U.S. Attorney, Eastern District of New York U.S. Department of Justice

Natalie Waites Assistant Director, Fraud Section, Civil Division U.S. Department of Justice

Justin G. Wood Diversion Program Manager, Washington Division Drug Enforcement Administration

Charles Graybow Senior Compliance Counsel Pfizer

Cory Kopitzke Assistant General Counsel, Regulatory Cardinal Health

Sarah Pechnick Senior Director Guidepost Solutions

Todd Prough, Ph.D Controlled Substance Monitoring Program AmerisourceBergen Former Head of Pharmaceutical Investigations, DEA

Julie Rapoport Schenker, Esq. Senior Counsel, Business and Litigation | Office of the General Counsel University of Maryland Medical System

Christine Roussel, PharmD, BCOP, BCSCP Senior Executive Director, Pharmacy, Laboratory and Medical Research Doylestown Health Member of the Pennsylvania Board of Pharmacy and Medical Marijuana Advisory Board

Dr. Berra Yazar-Klosinski Chief Scientific Officer MAPS Public Benefit Corporation

Jayne Conroy Shareholder

Simmons Hanly Conroy LLP

Ethan Davis Partner King & Spalding LLP

Hunter G. DeKoninck Attorney Quarles & Brady LLP

Delia Ann Deschaine Partner Epstein Becker Green LLP

Jay Dewald Partner | Head of Healthcare Investigations Norton Rose Fulbright US LLP

Uttam Dhillon Partner | Chair, Regulatory Defense, Compliance & White Collar Practice Group Michael Best & Friedrich LLP

Jonathan Havens Partner | Cannabis Law Practice Co-Chair Saul Ewing LLP

Marian J. Lee Partner Gibson, Dunn & Crutcher LLP

Matthew J McCarthy Special Counsel Duane Morris LLP

Jonathan M. Phillips Partner Gibson, Dunn & Crutcher LLP

Lowell Zeta Partner Hogan Lovells US LLP

Matthew C. Zorn Partner Yetter Coleman LLP

Conference DAY ONE

8:00 AM Registration and Breakfast

9:00 AM

Tuesday, March 14, 2023

Much of the $26 billion opioid settlement agreement announced in early 2022 will be used to fund state and subdivision initiatives for abatement of the opioid epidemic. However, not all the lawsuits are settled. In this session, topics of discussion include:

Opening Remarks from the Co-Chairs

Microphone Jolie Apicella, Partner, Wiggin & Dana LLP

Former AUSA, Chief of Healthcare Fraud, Eastern District of New York

Gustav Eyler, Partner, Gibson, Dunn, & Crutcher LLP

Former Director of Consumer Protection Branch, U.S. Department of Justice

Cori Rizman, Director, Compliance – Controlled Substances Oversight Region North America, Fresenius-Kabi USA

Former Diversion Investigator/Supervisor, DEA

9:15 AM

Fireside Chat with the DOJ

Microphone Arun Rao, Deputy Assistant Attorney General, U.S. Department of Justice, Civil Division

Anthony J. Nardozzi, Assistant Director, U.S. Department of Justice, Consumer Protection Branch, Civil Division

Lisa Miller, Deputy Assistant Attorney General | Fraud and Appellate Sections, U.S. Department of Justice, Criminal Division

9:45 AM

Reevaluating Controlled Substances Prescribing via Telehealth and Appreciating the Impact of the Expiring PHE

Microphone William Chang, Chief Legal Officer, Corporate Secretary, UpStream Healthcare

Julie Rapoport Schenker, Esq., Senior Counsel, Business and Litigation | Office of the General Counsel, University of Maryland Medical System

Nathan A. Beaver, Partner, Foley & Lardner LLP

Scott B. Dahlquist, Opioid Coordinator, Consumer Protection Branch, U.S. Department of Justice

• Considering the impact of the May 11, 2023, expiration of the PHE on controlled substances prescribing

» Will DEA create an official license for the prescribing of controlled substances via telehealth?

» Operating safely during the interim period of the expired PHE and the implementation of new DEA registrants for telehealth prescribers

• Detailing how the supply chain can prepare now for government’s plans to increase enforcement of telehealth prescribing

» Best practices for operating with differing state and federal requirements

10:45 AM Networking Break

11:00 AM

National Opioid Litigation and MDL Settlement Update: Tracking Settlements, Agreements, and the Role of State Attorney Generals

Microphone Monica Hanna, Special Counsel, Office of the New York State Attorney General

Jayne Conroy, Shareholder, Simmons Hanly Conroy LLP

• Lessons learned from the settled lawsuits and mitigation strategies for every link in the supply chain

» Evaluating the arguments concerning unlawful advertising and promotion of the consequences for manufacturers

» Identifying the arguments surrounding diversion and the consequences for distributors and pharmacies

• Update on the $26 billion settlement agreement

» What are the abatement initiatives and how will they be implemented

• Reviewing the lawsuits that have not settled and comparing the different legal arguments

» Analyzing the findings of the Johnson & Johnson Oklahoma trial and the implications for multidistrict litigation

» Making the strategic decision between judge-alone or jury trials

11:45 AM

DOJ Keynote: Recent DOJ Civil and Criminal Enforcements

Microphone Amanda Liskamm, Director, Consumer Protection Branch, U.S. Department of Justice

12:15 PM Networking Lunch

1:15 PM

Responding to Emerging Enforcement Trends –Counterfeit Pills, Precursors, and Amphetamines

Microphone Ethan Davis, Partner, King & Spalding LLP

Jonathan Lenzner, Chief of Staff, Federal Bureau of Investigation

Uttam Dhillon, Partner | Chair, Regulatory Defense, Compliance & White Collar Practice Group, Michael Best & Friedrich LLP

Gabriel H. Scannapieco, Assistant Director, Consumer Protection Branch, United States Department of Justice

Moderator: Gustav Eyler, Partner, Gibson, Dunn, & Crutcher LLP, Conference Co-Chair

• Update on expanded efforts to interdict counterfeit pills

• Examining investigative and enforcement approaches aimed at stopping necessary precursor chemicals and equipment from reaching illegal drug manufacturers

• Developing corporate engagement protocols to improve responsible sales, distribution, and reporting

• Enforcement tools, approaches, and considerations related to amphetamine manufacturing, distribution, and dispensing

• Compliance advice for corporate actors associated with or transacting in relevant chemicals, equipment, or drugs

Supply Chain Due Diligence for Manufacturers and Distributors: A Deep Dive into Satisfying DEA Diversion Obligations and Streamlining Suspicious Order Monitoring

Microphone Hunter G. DeKoninck, Partner, Quarles & Brady LLP

Cory Kopitzke, Assistant General Counsel, Regulatory, Cardinal Health

Todd Prough, Ph.D., Controlled Substance Monitoring Program, AmerisourceBergen, Former Head of Pharmaceutical Investigations, DEA

Sarah Pechnick, Senior Director, Guidepost Solutions

• Unpacking Suspicious Order Monitoring (SOMS) parameters:

» What exactly constitutes a “suspicious order” (SO) and a “order received under suspicious circumstances” (ORUSC) and what does that mean in practical terms for distributors

• Learning how to design and operate a system to identify SOs and ORUSCs

» What information must you include when you report a suspicious order or ORUSC to DEA?

• Understanding the benefits of an ERP system and knowing the legal and compliance aspects of utilizing technology to fulfill diversion obligations

• Training employees to comply with SOMS requirements

• Best practices for conducting virtual and onsite visits with prospective customers

» Knowing where to search for relevant information and knowing the right questions to ask

» Identifying the common and lesser-known red flags according to industry practice, legislative guidance and case law

» Considering the unique due diligence for international supply chains

3:30 PM Networking Break

3:45 PM PHARMACIST SPOTLIGHT

Every Pharmacist and Non-Pharmacist Needs to Know About Proper Administration and Diversion of Prescribed Controlled Substances

Microphone Janet Hart, Director, Government Affairs, Rite Aid

Venue Information

Elliot Schachner, Assistant U.S. Attorney, Eastern District of New York, U.S. Department of Justice

• Lessons learned from recent pharmacy chain rulings regarding diversion and how to not let this happen to your business

• Developing best practices for communicating with prescribers when the necessity of the prescription is in question

» Protocols for following up with prescriber red flags

» Knowing which red flags to report

• Analyzing guidelines and factors for determining the likelihood of diversion from the patient

» Utilizing the Prescription Drug Monitoring Program as a tool

» Going beyond reporting: can pharmacists refuse to fill prescriptions?

• Incorporating the Model State Pharmacy Act and Model Rules of National Association of Boards of Pharmacy (Model Act) and the PhRMA Code

4:45 PM

Ruan v. United States: What Prescribers and Their Lawyers Need to Know

Microphone Jay Dewald, Partner | Head of Healthcare Investigations, Norton Rose Fulbright US LLP

Ronald Chapman, President, Chapman Consulting Group

In July of 2021, the Supreme Court in Ruan v the United States ruled that the Government must prove the defendant knowingly or intentionally acted in an unauthorized manner to find them guilty of unauthorized distribution of controlled substances. One year later, authorized prescribers need to know how this standard is being applied in practice to adopt their behaviors accordingly. In this session, topics of discussion include:

• Understanding the guidance released by HHS following the Ruan and Khan cases

• Adapting prescribing practices and procedures based on the outcome

• How is Ruan informing DOJ charging decisions, and what that means for your compliance program moving forward

5:45 PM

Day One Adjourns

American Conference Institute is pleased to offer a variety of hotel suggestions near the DC Bar Association.

Hotel: Hampton Inn Washington-Downtown Convention Center

Address: 901 6th St NW, Washington DC 20001

Reservations: (202) 842-2500

In-Person Conference Participation Requirements

Please note that the D.C. Bar Association facility currently has COVID-19 vaccination requirements in place for all visitors.

All visitors to the facility must be “Fully Vaccinated“ - or - non-vaccinated individuals will require proof of a negative COVID-19 test from a healthcare provider or testing facility. At-home or self-administered test results will not be accepted. Negative test results must be accompanied with a government-issued ID.

Upon arrival, you will be required to present your CDC COVID-19 Vaccination Record Card, or a similar record for visitors who are residents of countries other than the U.S., to security personnel located in the building lobby. Vaccination proof or negative test results must be accompanied with a government-issued ID.

While on-site, individuals are not required to wear face masks but are encouraged to do so and practice social distancing.

Hotel: Homewood Suites by Hilton Washington DC Convention Center

Address: 465 New York Ave NW, Washington DC 20001

Reservations: (202) 628-4663

The D.C. Bar Associations has the following requirements in place to be considered “Fully Vaccinated”.

U.S. Residents:

Visitors must have received two (2) doses of the Pfizer-BioNTech or Moderna vaccine, OR a single dose of the Johnson & Johnson/Janssen vaccine; AND

Visitors must have received at least one booster shot in accordance with the current CDC guidelines.

International Visitors:

Visitors must have received doses of the COVID-19 vaccines listed below in any combination in accordance with current World Health Organization (WHO) guidelines.

AstraZeneca/Oxford vaccine Johnson and Johnson Moderna

What

8:00 AM Registration and Breakfast

9:00 AM

Opening Remarks from the Co-Chairs

Microphone Jolie Apicella, Partner, Wiggin & Dana LLP

Former AUSA, Chief of Healthcare Fraud, Eastern District of New York

Gustav Eyler, Partner, Gibson, Dunn, & Crutcher LLP

Former Director of Consumer Protection Branch, U.S. Department of Justice

Cori Rizman, Director, Compliance – Controlled Substances Oversight Region North America, Fresenius-Kabi USA

Former Diversion Investigator/Supervisor, DEA

9:15 AM

Keynote: FDA Enforcement Priorities

Microphone Dominic Chiapperino, Ph.D., Director, Controlled Substance Staff, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

9:45 AM

Scheduling and Rescheduling Controlled Substances

Microphone Matthew C. Zorn, Partner, Yetter Coleman LLP

Delia Ann Deschaine, Partner, Epstein Becker Green

• Reviewing the legal pathways to scheduling and rescheduling: administrative and legislative

» Assessing the credibility and reliability of the data and evidence used in the scheduling process

SQUARE Strategies for demonstrating a drug has little or no potential for abuse

• Historical review of drugs that have been scheduled legislatively (e.g., gamma-hydroxybutyric acid, a date rape drug)

• Understanding how and when public petitions for administrative scheduling occur (e.g., the 2002 rescheduling of buprenorphine)

• An update on the challenge to DEA’s rescheduling petition denial (Right to Try) in the U.S. Court of Appeal’s 9th circuit

• Considering international treaties in the context of rescheduling

10:45 AM Networking Break

11:00 AM

Taking the Bad Trip Out of Psychedelic Medicines: Investing in An Emerging New Paradigm in Therapeutics

Microphone Kimberly I. Chew, Partner | Co-founder and Co- Lead of Psychedelic and Emerging Therapies Practice Group, Husch Blackwell LLP

Dr. Berra Yazar-Klosinski, Chief Scientific Officer, MAPS Public Benefit Corporation

Psychedelics are increasingly making headlines, especially for the treatment of mental illnesses such as PTSD. Exciting new drug applications involving MDMA, DMT, and psilocybin are making their way through clinical trials and the political and public policy cadence continues to shift towards recognizing the medical value of psychedelics; the DEA is also looking to dramatically boost the production quotas of certain psychedelics, including LSD, psilocyn and mescaline.

• Which psychedelics are closest to FDA approval and which remain on the fringes?

• Navigating the difficulty of securing psychedelics for research in order to demonstrate its medical value

» Best practices for applying for a DEA research license

» Partnering with universities and research institutions

• Best practices for comprehensive IND and NDA applications

• Reviewing the other pathways including Special Protocol Assessment, Breakthrough Therapies, Fast Track and Priority Review

12:00 PM

Breaking Into the Cannabis Market: Balancing the Profits Against the Risks of Non-Compliance

Microphone Jonathan Havens, Partner | Cannabis Law Practice Co-Chair, Saul Ewing LLP

Christine Roussel, PharmD, BCOP, BCSCP, Senior Executive Director, Pharmacy, Laboratory and Medical Research, Doylestown Health

Member of the Pennsylvania Board of Pharmacy and Medical Marijuana Advisory Board

Matthew J McCarthy, Special Counsel, Duane Morris LLP

In October 2022, the Biden Administration announced that it would begin pardoning all prior offences of simple possession of marijuana and asked that DEA and FDA begin the administrative process to review how marijuana is scheduled under federal law. DEA has also proposed to more than double the amount of cannabis that can be legally manufactured for research in 2023. The implications of rescheduling marijuana are massive, and may transform the cannabis market into one that is legal at the federal as well as state level. In this session, topics of discussion include:

• Reviewing DEA and FDA stances on Delta 8 THC

» Are designer compounds worth the risk of attracting DEA or FDA interest?

• Drawing on the experiences of pre-existing companies within the hemp and medicinal marijuana industries to set their business up as FDA and DEA compliant

• Developing business solutions for the inability of state companies to use federal banks and federal tax deductions

• Understanding how hemp products can and cannot be marketed

1:00 PM Networking Lunch

2:15 PM

Ensuring cGMP Compliance and Quality Standards for Controlled Substances

Microphone Francis Godwin, Director, Office of Manufacturing Quality, U.S. Food and Drug Administration

Marian J. Lee, Partner, Gibson, Dunn & Crutcher LLP

Lowell Zeta, Partner, Hogan Lovells US LLP

• Reviewing current Good Manufacturing Practice regulations relative to controlled substances

» Ensuring product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs.

• Knowing the standards for active pharmaceutical ingredients

» Learning the unique considerations for contract manufacturing

• Reviewing the current Chemistry, Manufacturing and Controls regulations

» Synchronizing CMC and GMP

» Considering the draft Quality System Regulation and OMB’s review

3:15 PM Networking Break

3:30 PM

Managing the Finer Points of Parallel Investigations: Reconciling the Requirements of the False Claims Act and the Controlled Substances Act

Microphone

Matthew Feeley, Deputy Chief & Healthcare Fraud Coordinator, USAO SDFL Civil Division, U.S. Department of Justice

Natalie Waites, Assistant Director, Fraud Section, Civil Division, U.S. Department of Justice

Jonathan M. Phillips, Partner, Gibson, Dunn & Crutcher LLP

Charles Graybow, Senior Compliance Counsel, Pfizer

Moderator: Jolie Apicella, Partner, Wiggin & Dana LLP

Former AUSA, Chief of Healthcare Fraud, Eastern District of New York Conference Co-Chair

Parallel investigations have unique considerations that must be considered when developing your legal, compliance and business strategies

Enforcement trends show that federal authorities target individual actors for criminal sanctions under the Controlled Substances Act, and target corporate entities for civil remedies, frequently under both the False Claims

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Act and the Controlled Substances Act. Parallel investigations have unique considerations that must be considered when developing your legal strategy. In this session, topics of discussion include:

• Reviewing the CSA civil penalty and FCA framework to understand what actions may give rise to a claim under the Act;

» Understanding CSA civil provisions

» Learning the anatomy of an FCA lawsuit

• Implementing effective and comprehensive FCA compliance measures and outlining best practices to maintain FCA compliance

• Distinguishing between corporate and individual liability and knowing which factors can negatively or positively affect the other

» When is it in the corporation’s interest to self-disclose and cooperate with investigations into individual actors within the corporation?

» What are the privacy and self-incrimination considerations?

» Understanding the new Monaco memo requirements

• Knowing when to hire outside counsel to avoid conflicts of interest

4:30 PM

Responding Effectively to DEA Investigations: Tailoring Inspection Strategies for Every Link in the Supply Chain

Microphone Joseph J. Bogdan, Founding Lawyer, The Law Offices of Joseph J. Bogdan, LLC

Justin Wood, Diversion Program Manager, Drug Enforcement Administration

Moderator: Cori Rizman, Director, Compliance – Controlled Substances Oversight Region North America, Fresenius-Kabi USA Former Diversion Investigator/Supervisor, DEA

• Responding to Letters of Admonition within the allotted time frame

• Understanding when to participate in Informal Administrative hearings with DEA

» Knowing when self-disclosure goes too far

» Negotiating suitable terms for a Memorandum of Understanding

• Preparing for an Order to Show Cause

» Learning the legal argument trends that do and do not result in license revocation

» Dealing with license revocation

• Working within the confines of an Immediate Suspension Order

5:30 PM

Conference Concludes

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