American Conference Institute's 37th FDA Bootcamp - WEB by C5Group

EARN CLE/ETHICS CREDITS

September 29–30, 2021 (EST) • Virtual Conference

AMERICAN CONFERENCE INSTITUTE’S 37th

FDA

BOOT CAMP

Training in Core Regulatory Concepts for Life Sciences Attorneys, Business Executives, and Policy Analysts

Further Enhance Your Knowledge with our In-Depth Workshops: Workshop A

Distinguished Conference Chairs: Christopher Mikson Partner DLA Piper LLP (Washington, DC)

Chad Landmon Partner Axinn, Veltrop & Harkrider LLP (Hartford, CT)

(1 hour Ethics Bonus) FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you: Angle-Right COMPREHEND the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR

Workshop B Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations

Angle-Right MASTER the basics of the application and approval processes for drugs and biologics Angle-Right APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products

Angle-Right GAIN a practical working knowledge of clinical trial process for pharmaceutical products

Workshop C

Angle-Right RECOGNIZE the pivotal role of labeling in the drugs and biologics approval process

Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

Angle-Right DECIPHER the requirements for the advertising, marketing, and promotion of drugs

and biologics

Angle-Right UNDERSTAND the importance of cGMPs to the post-approval regulatory process

AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

For over 15 years, this Conference has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Law and Regulation. It’s Time for You to Join Their Ranks. The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. Recent news stories and highprofile trials concerning FDA-regulated products have made it clear that it is critical for attorneys who do not have regulatory practices and life sciences executives who deal with FDA-regulated products to have a familiarity with these concepts. For this reason, ACI’s FDA Boot Camp returns for its 37th iteration – in a fully virtual format – with the continued intent of providing these individuals with an essential working knowledge of core FDA concepts, and real world examples that will help them to excel in their everyday practices. A distinguished faculty of top FDA regulatory authorities— a “Who’s Who of the FDA Bar” — will share their knowledge and provide you with critical insights on: Angle-Right The organization, jurisdiction, functions, and operations of FDA

Angle-Right The essentials of the approval process for drugs and biologics

Angle-Right The role of the Hatch-Waxman Act in the patenting of drugs and biologics

Angle-Right Clinical trials for drugs and biologics

Angle-Right Labeling in the drug and biologics approval process Angle-Right cGMPs and other manufacturing concerns relative to products liability

Angle-Right Proactive adverse events monitoring and signal detection

Angle-Right Recalls, product withdrawals, and FDA oversight authority

Interactive Virtual Conference Experience This program is designed to bring the dynamic, in-person conference experience to you virtually with multiple ways to engage with speakers, stay connected with industry peers and expand your professional network through 1-on-1 conversations.

Participate in Meaningful Networking Enjoy an Easy to Use, Dynamic Online Platform Immerse Yourself in Live Presentations and Panel Discussions Engage with Attendees and Speakers in an Interactive Format Meet 1-on-1 with Your Fellow Attendees

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DISTINGUISHED SPEAKER FACULTY: CO-CHAIRS: Christopher Mikson Partner DLA Piper LLP (Washington, DC) Chad Landmon Partner Axinn, Veltrop & Harkrider LLP (Hartford, CT) SPEAKERS: Torrey Cope Partner Sidley Austin LLP (Washington, DC) Bryan C. Diner Partner Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Colleen M. Heisey Partner Jones Day (Washington, DC) Karin Hessler Assistant General Counsel Association for Accessible Medicines (Washington, DC) Michael Hinckle Partner KL Gates LLP (Washington, D.C.) Amy Johnson Counsel Faegre Drinker Biddle & Reath LLP (Washington, DC) Kurt R. Karst Partner Hyman, Phelps & McNamara, P.C. (Washington, DC)

Donna M. Meuth Associate General Counsel, Intellectual Property Eisai Inc. (Boston, MA) Neil O’Flaherty Partner Amin Talati Wasserman LLP (Washington, DC) David L. Rosen Partner Foley & Lardner LLP (Washington, DC) Jonathan B. Roses Counsel Wolf, Greenfield & Sacks, P.C. (Boston, MA) Marc J. Scheineson Partner Alston & Bird LLP (Washington, D.C.)

Daniel Dwyer Partner Kleinfeld Kaplan & Becker LLP (Washington, D.C.)

Seth A. Mailhot Partner Husch Blackwell LLP (New York, NY)

Christopher A. Fanelli Partner Sidley Austin LLP (Boston, MA)

Brian Malkin Partner McDermott Will & Emery LLP (Washington, DVC)

Michael A. Walsh Partner Parsons McEntire McCleary PLLC (Dallas, TX)

Christina Markus Partner, Deputy Chair of the FDA & Life Sciences Group King & Spalding LLP (Washington, DC)

Emily R. Whelan Partner WilmerHale (Boston, MA)

Maya P. Florence Partner Skadden, Arps, Alate, Meagher & Flom LLP (Boston, MA)

Alexander Varond Partner Goodwin (Washington, DC)

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. EARN CLE/ETHICS CREDITS

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. For more information on ACI’s CLE process for virtual events visit: www.americanconference.com/accreditation-instructions-for-virtual-attendance/

AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Pre-Conference Workshop A

September 28, 2021 (EST)

EARN 1 ETHICS BONUS CREDIT

9:00 AM – 12:00 PM (10:30 – 11:00 AM Break)

FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws microphone-alt Seth A. Mailhot, Partner, Husch Blackwell LLP (New York, NY) This workshop, provides a basic overview of FDA regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of FDA and obtain a basic understanding of the pre-approval, approval, and post-approval processes. This session also provides a built- in hour of ethics credit. Topics of discussion will include: • Examining the FDA’s structure, authority, and organization

• Evaluating post-market dilemmas and enforcement

• The 3 major FDA centers and their roles

• Understanding recalls and withdrawals

» CDER (Drug); CBER (Biologics); CDRH (Device)

• Examining recent developments at FDA

• Reviewing major FDA regulations and applicable laws

• FDA’s policies and procedures

• Defining drugs, biologics, and devices

» Administrative Procedures Act

• Understanding the role of labeling with respect to these definitions • Differentiating types of drug applications (INDs, NDAs, and ANDAs) • Exploring the clinical trials process • Investigating biological products and biosimilars 12:00 PM – 1:30 PM

• Working with the FDA through formal and informal dispute resolution mechanisms • Analyzing ethical dilemmas that may occur throughout various stages of interaction with the FDA, including the approval process related to the disclosure of adverse information

Lunch Break

Pre-Conference Workshop B

September 28, 2021 (EST)

1:30 PM – 4:30 PM (2:30 – 3:00 PM Break)

Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations microphone-alt Neil O’Flaherty, Partner, Amin Talati Wasserman LLP (Washington, DC) This workshop will provide an introduction and in-depth overview of medical devices, combination products, and companion diagnostics as well as the FDA regulations which govern these products. Topics of discussion will include:

MEDICAL DEVICES • Reviewing the history of FDA device regulations

• Assessing strategies to obtain clinical data

• Examining the basics of device classification and the FDA’s review process

• Determining premarket approvals

• Analyzing the clinical trials process for medical devices

• Exploring the 510(k) clearance process • Discussing key regulatory requirements, information, and concepts

COMBINATION PRODUCTS • Defining the requirements for combination product classification and approval

• Determining the role of the Combination Product Policy Council and agencies regulating combination products

• Selecting the proper regulatory pathway

• Examining existing cGMP’s for combination products

• Exploring the Request for designation (RFD) process and the newly-created pre-RFD process

COMPANION DIAGNOSTICS • Exploring the regulations of laboratory developed tests (LDTs)

• Utilizing companion diagnostics via smart technologies

• Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs

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Main Conference Day 1

September 29, 2021 (EST)

8:15 AM

Co-Chairs’ Opening Remarks microphone-alt Christopher Mikson, Partner, DLA Piper LLP (Washington, DC) Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP (Hartford, CT) 8:30 AM

Understanding the Relevance New FDA Initiatives and Policies and How they May Redefine the Life Sciences Industry in the Aftermath of Covid-19 microphone-alt Christopher Mikson, Partner, DLA Piper LLP (Washington, DC) Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP (Hartford, CT) The COVID-19 Pandemic has impacted thousands of businesses and organizations around the world. This opening session will focus on the actions of the U.S. Food and Drug Administration to protect public ensure the public has access to safe food and medical supplies, as well as its impact on the pharmaceutical and biologics industries.

THE PRE-APPROVAL AND APPROVAL PROCESS 9:15 AM

Navigating the Approval Process for Drugs and Biologics microphone-alt Torrey Cope, Partner, Sidley Austin LLP (Washington, DC) Alexander Varond, Partner, Goodwin (Washington, DC)

Innovator Products: New Drug Applications and Biologic License Applications THE DRUG REVIEW PROCESS • Reviewing the fundamentals of applications; from submission, through filing and beyond

BIOLOGICAL PRODUCTS (LARGE MOLECULES) • What are biological products in relation to traditional drugs? • Deciphering the biologics license application (BLA) • How do the research, development, and approval process for biological products differ from the process for new drugs? • Exploring key similarities and differences between the drug and biological product schemes

NDAS AND BLAS • Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs • Identifying applications for fixed-dose combination drugs • Distinguishing complex molecules regulated through NDAs from small molecules • Examining standards for approvals • REMS

OTC PRODUCTS • Understanding the concept of “OTC” (OTC-ness) • Examining the OTC Review and monographs » Differences between approved and monographed OTC drug products • Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements 10:15 AM

Morning Break

10:45 AM

Exploring FDA's Expedited Programs: Applicability and Eligibility microphone-alt Colleen M. Heisey, Partner, Jones Day (Washington, DC) David L. Rosen, Partner, Foley & Lardner LLP (Washington, DC) Distinguishing among the different FDA programs for expedited review and approval of drug products

• Making sense of PDUFA Goals, fast track, break through status, and other process enhancements

• Evaluating the criteria for eligibility, benefits, and limitations of each program

• Use of administrative appeals

• Understanding accelerated approval, surrogate and intermediate clinical endpoints

RX DRUGS (SMALL MOLECULES) • Understanding the difference between “new drugs” and other drugs

• Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs

• Examining the research, development, and approval process for new drugs

• Reviewing priority review

• Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)

• Factoring expedited programs into your drug development strategy

Expedited Approval Case Study: Chasing the COVID-19 Vaccine This case study will focus on the expedited approval process and other related health submissions to further access a COVID-10 vaccine for Americans. Experts will also identify any legislation that is being used to support the approval process.

AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

11:45 AM

12:00 PM

1:1 Networking Break

Lunch Break

• Applying for and achieving extension of patent term for time spent in the drug approval process » Patent Term Extension (“PTE”) » Patent Term Adjustment (“PTA”)

12:45 PM

Appreciating the Nuances of the Approval Process for Controlled Substances microphone-alt Brian Malkin, Partner, McDermott Will & Emery LLP (Washington, DVC)

• Defining the term “controlled substance”? • Reviewing the scheduling process for both approval as well as postmarketing approval with both the DEA and FDA • Discussing the proper steps for companies who incorporate CBD’s into their products • What clinical trial lab work is necessary to demonstrate to the proper agencies? • Exploring state regulations which exist when working with controlled substances • Implementing the manufacturing quotas which exist for these products 1:30 PM

Clarifying the Clinical Trial Process for Drugs and Biologics microphone-alt Amy Johnson, Counsel, Faegre Drinker Biddle & Reath LLP (Washington, DC)

• Overview of clinical trials and how they are used (including different phases) • Identifying the different parties involved (sponsors, investigators, CROs, etc.) • Understanding human research protection (ICF, IRB) • Enforcement

• Reviewing the 271(e)(1) “safe harbor” provision • Distinguishing the patenting process for drugs from that of biologics • Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products

TRADEMARKS • Overview of selecting a brand name for a proposed drug product • Roles of the USPTO and FDA in the drug naming process • Identifying the PTO and FDA clearances necessary for trade name/ trademark approval on your product • How does the branding process work for your product 3:45 PM

Part 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry microphone-alt Bryan C. Diner, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Kurt R. Karst, Partner, Hyman, Phelps & McNamara, P.C. (Washington, DC) DRUGS • Overview of Hatch-Waxman and reforms » 30-month stay; patent extensions; ANDA filer exclusivity (180 day) • Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes » Reviewing fundamentals of applications

• Review of the “Right to Try” laws and their requirements during the clinical trials process

• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters

2:30 PM

• Examining ANDA Standards for approval and the concepts of sameness and bioequivalence

Afternoon Break

IP OVERVIEW FOR DRUGS AND BIOLOGICS: HATCH-WAXMAN, BPCIA, TRADEMARKS, AND MORE 3:00 PM

Part 1 – Patents and Related IP Protections and Mechanisms microphone-alt Karin Hessler, Assistant General Counsel, Association for Accessible Medicines (Washington, DC)

Donna M. Meuth, Associate General Counsel, Intellectual Property, Eisai Inc. (Boston, DC) PATENT PROTECTION FOR DRUGS AND BIOLOGICS • Summarizing the patenting process for drugs and biologics

• Special considerations: local acting drugs, labeling carve outs and other nuances » Understanding the role of the Orange Book in the drug approval process » Listings, de-listings and use codes • Market exclusivities and protection • Identifying the different types of exclusivities » Regulatory exclusivity (FDA)/ (data) exclusivity - NCE (new chemical entity) » 5 years data exclusivity - indication (new indication or use) » 3 years marketing exclusivity - NDF (new dosage formulation) - ODE (orphan drug exclusivity) - PED (pediatric exclusivity)

• Strategies for building patent protection for drugs and biologics

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BIOLOGICS • Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA) • Understanding the rationale for safety and efficacy concerns surrounding second generation biologics • Exploring the concepts of “biosimilarity” or “interchangeability” • FDA rule-making and guidance relative to biosimilars • Other points for consideration: substitution, naming, patents, and additional nuances • Examining biosimilar exclusivities • “Shall we dance” — weighing the pros and cons of participating in the patent dance • Deciding when to provide notice of commercial marketing

Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process microphone-alt Michael Hinckle, Partner, KL Gates LLP (Washington, D.C.) The labeling of the drug/biologic is the final stage of the approval process. The label controls what you can do post-approval and as such it is the point of transition between the approval process and post-approval world. • Labeling overview: key regulatory requirements, information, and contents • Exploring the review process for labeling • Incorporating clinical trial data on the label • Appreciating the influence of final labeling on the scope of post-market activities • Amending labeling post-market • Using labeling as a defense in products liability litigation

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4:45 PM

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Main Conference Day Two

• Exploring label carve outs • Discussing the requirements for skinny and narrow labeling 5:30 PM

Conference Adjourns to Day Two

September 30, 2021 (EST)

8:40 AM

Co-Chairs’ Remarks and Recap of Day One microphone-alt Christopher Mikson, Partner, DLA Piper LLP (Washington, DC) Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP (Hartford, CT) 8:45 AM

cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process microphone-alt Christina Markus, Partner, Deputy Chair of the FDA & Life Sciences Group, King & Spalding LLP (Washington, DC)

• Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/biological product commercialization • Factoring cGMPs into the scope of the FDA’s authority • Exploring the scope of the FDA’s cGMP Initiative and the concept of “risk-based” cGMPs • Conducting laboratory investigations in relation to cGMPs • Understanding the influence of cGMPs in products liability litigation • Evaluating the costs and impact of enforcement actions

ADVERTISING, PROMOTIONS, AND RELATED FIRST AMENDMENT CONCERNS 9:45 AM

Part 1 – Drug and Biologics Advertising and Promotion 101 microphone-alt Marc J. Scheineson, Partner, Alston & Bird LLP (Washington, D.C.)

• Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics » 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA » Guidance documents • Exploring the role of DDMAC (Division of Drug Marketing, Advertising and Communications) » What duties and responsibilities is DDMAC charged with? » What are its enforcement capabilities and jurisdiction? • Identifying the role of the FTC in the advertising and promotion of drugs » SEC? • Advertising requirements for prescription v. nonprescription products • Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials » Overview of the promotional materials submission and review process • What constitutes a launch? • What defines an advertisement? » What information must a drug advertisement include? • Exploring the role of the label in advertising

AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

10:30 AM

Morning Break

• Identifying risk minimization tools • Enforcing ADE reporting and REMS requirements

11:00 AM

Part 2 – Exploring the Subtleties and Safe Zones of Off-Label Communications microphone-alt Michael A. Walsh, Partner, Parsons McEntire McCleary PLLC (Dallas, TX)

• Clarifying FDA’s current position on First Amendment and off-label promotion

• Examining the relevance to product liability risks, including innovator and co-promoter liability risks • What is the FDA’s recall and oversight authority (overview of 21 CFR Part 7)? » Guidance versus regulation » Voluntary recalls versus mandatory recalls » Market withdrawals and stock recoveries • Interaction between recalls and corrective and preventive action

» The 21st Century Cures Act » FDAMA 114 • What to expect concerning proposed legislation, rules changes and Citizen Petitions • Cases and controversies: state AG actions and private tort claims 11:45 PM

Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls microphone-alt Daniel Dwyer, Partner, Kleinfeld Kaplan & Becker LLP (Washington, D.C.)

Maya P. Florence, Partner, Skadden, Arps, Alate, Meagher & Flom LLP (Boston, MA) • What is pharmacovigilance?

12:45 PM

Understanding the Scope of FDA Enforcement Authority and Actions microphone-alt Christopher A. Fanelli, Partner, Sidley Austin LLP (Boston, MA) • Enforcement overview—identifying the players and their positions » Investigations, enforcement, litigation, and defenses • Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions • Exploring FDA compliance and enforcement mechanisms » Inspections - For cause inspections vs. routine inspections - Communication with the FDA during inspections

• How pharmacovigilance uses adverse event reports

» EIRs

» Direct versus indirect reports

» Form FDA 483 observations

» Causality assessments

» Untitled and Warning Letters

» Labeling changes

- Related to inspections

» Pre-and post-market ADE reporting requirements

- Resulting from non-inspection data or information

» How regulatory agencies use ADE reports • Exploring protocols for Risk Evaluation and Minimization Strategies (REMS) • Understanding the role of risk evaluation in the approval process

Post-Conference Workshop C

• Examining enforcement actions related to digital advertising and social media 1:30 PM

Main Conference Ends

September 30, 2021 (EST)

2:30 PM – 5:30 PM (3:30 – 4:00 PM Break)

Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group microphone-alt Jonathan B. Roses, Counsel, Wolf, Greenfield & Sacks, P.C. (Boston, MA) Emily R. Whelan, Partner, WilmerHale (Boston, MA) This workshop will build upon the content covered during the main conference on the regulatory and IP interplay in the Hatch-Waxman and BPCIA schematics. Our workshop leaders will in a step by-step manner: • Deconstruct complex exclusivity disputes, • Analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity • Explore bioequivalency conundrums

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Relevant court decisions will also be analyzed and their practical and future effects discussed. Workshop attendees will have the opportunity to understand how the exclusivity “rules of the road” are applied in a real-world case.

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