American Conference Institute's 38th FDA Boot Camp - DS

EARN CLE/ETHICS CREDITS

American Conference Institute’s 38 th

March 23–24, 2022 (EST)

Virtual Conference

Training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts.

Distinguished Co-Chairs:

Join us for Pre- and Post-Conference Workshops: March 22, 2022:

A | FDA 101: A Guide to Agency

Kurt R. Karst Partner Hyman, Phelps & McNamara, P.C.

Veleka R. Peeples-Dyer Chief Legal Officer and Chief Compliance Officer Opentrons Labworks, Inc.

Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you: CHEVRON-RIGHT COMPREHEND the structure of FDA and the roles of the three major

agency centers: CDER, CBER, and CDHR

Structure, Jurisdiction, Regulation, and Applicable Laws + 1 Hour Ethics Bonus

CHEVRON-RIGHT MASTER the basics of the application and approval processes for

B | Medical Devices, Combination

CHEVRON-RIGHT APPRECIATE the complexities of pharmaceutical IP and the regulatory

Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations

drugs and biologics

balance between brand name and generic products

CHEVRON-RIGHT GAIN a practical working knowledge of clinical trial process for

pharmaceutical products

CHEVRON-RIGHT RECOGNIZE the pivotal role of labeling in the drugs and biologics

March 24, 2022:

C | Hatch-Waxman and BPCIA

in the Trenches: Exclusivity and Bioequivalency Working Group

approval process

CHEVRON-RIGHT DECIPHER the requirements for the advertising, marketing, and

promotion of drugs and biologics

CHEVRON-RIGHT UNDERSTAND the importance of cGMPs to the post-approval

Reconnect Virtually with Your Colleagues

regulatory process

Expand Your Network with 1:1 Networking REGISTER NOW

AmericanConference.com/FDABootCamp • 1 888 224 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 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 high-profile 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 38th 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: ĉ The organization, jurisdiction, functions, and operations of FDA ĉ The essentials of the approval process for drugs and biologics ĉ The role of the Hatch-Waxman Act in the patenting of drugs and biologics ĉ Clinical trials for drugs and biologics

ĉ Labeling in the drug and biologics approval process ĉ cGMPs and other manufacturing concerns relative to products liability ĉ Proactive adverse events monitoring and signal detection ĉ Recalls, product withdrawals, and FDA oversight authority

cogs

Maximize your knowledge and networking experience by attending one or more of our workshops: Pre-Conference Workshop A: FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws +1 Hour Ethics Bonus

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

Post-Conference Workshop C: Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

We look forward to seeing you in March!

REGISTER NOW

2 | #FDABootCamp twitter: @ACI_Pharma

linkedin: ACI: Pharmaceutical/Biotech/Life Sciences

2022 Faculty List CO-CHAIRS Kurt R. Karst Partner Hyman, Phelps & McNamara, P.C. (Washington, DC)

Veleka R. Peeples-Dyer Chief Legal Officer and Chief Compliance Officer Opentrons Labworks, Inc. (Washington, DC)

DISTINGUISHED FACULTY Maureen Bennett Partner, Life Sciences Co-leader for the Firm’s Health Care & Life Sciences Practice Jones Day LLP (Boston, MA)

Adam L. Perlman Partner Latham & Watkins LLP (Washington, DC)

Jennifer L. Bragg Partner Skadden LLP (Washington, DC)

Evan Phelps Partner Amin Talati Wasserman LLP (Washington, DC)

Bryan C. Diner Partner Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Stephanie Philbin Partner Goodwin Procter LLP (Washington, DC)

John Fuson Partner Crowell & Moring LLP (Washington, DC)

Kinsey S. Reagan Partner Kleinfeld, Kaplan and Becker, LLP (Washington, DC)

Michael Hinckle Partner K&L Gates LLP (Washington, DC) Joel Kurtzberg Partner Cahill Gordon and Reindel LLP (New York, NY) Seth A. Mailhot Partner Husch Blackwell LLP (Washington, DC) Lynn Mehler Partner Hogan Lovells (Washington, DC) Christopher Mikson Partner DLA Piper LLP (Washington, DC) Jason Murata Partner Axinn, Veltrop & Harkrider LLP (Harford, CT)

REGISTER NOW

David L. Rosen Partner Foley & Lardner LLP (Washington, DC) Jonathan B. Roses Counsel Wolf, Greenfield & Sacks, P.C. (Boston, MA) Marc J. Scheineson, Esq. Partner Alston & Bird LLP (Washington, DC) Beth P. Weinman Partner Ropes & Gray LLP (Washington, DC) Emily R. Whelan Partner WilmerHale (Boston, MA)

AmericanConference.com/FDABootCamp • 1 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Pre-Conference Workshops Tuesday, March 22, 2022 (EST)

+1 HOUR ETHICS BONUS

WORKSHOP A

clock 9:00 AM – 12:30 PM

FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws microphone-alt

Christopher Mikson, Partner, DLA Piper LLP (Washington, DC)

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 • Assessing the 3 major FDA centers and their roles - CDER (Drug); - CBER (Biologics); - CDRH (Device) • Reviewing major FDA regulations and applicable laws • Defining drugs, biologics, and devices • 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 • Evaluating post-market dilemmas and enforcement

Understanding recalls and withdrawals Examining recent developments at FDA Reviewing FDA’s policies and procedures Understanding the Administrative Procedures Act 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 • • • • •

WORKSHOP B

clock 1:30 PM – 5:00 PM

Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations microphone-alt

Evan Phelps, Partner, Amin Talati Wasserman LLP (Washington, DC) Stephanie Philbin, Partner, Goodwin Procter 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 Examining the basics of device classification and the FDA’s review process Analyzing the clinical trials process for medical devices Assessing strategies to obtain clinical data

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

Combination Products • Defining the requirements for combination product classification and approval • Selecting the proper regulatory pathway • Exploring the Request for designation (RFD) process and the newly-created pre-RFD process

• Determining the role of the Combination Product Policy Council and agencies regulating combination products • Examining existing cGMP’s for combination products

Companion Diagnostics • Exploring the regulations of laboratory developed tests (LDTs) • Utilizing companion diagnostics via smart technologies

4 | #FDABootCamp twitter: @ACI_Pharma

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

linkedin: ACI: Pharmaceutical/Biotech/Life Sciences

Day One

Wednesday, March 23, 2021 (EST) 8:15 AM

Co-Chairs’ Opening Remarks

microphone-alt

Kurt R. Karst, Partner, Hyman, Phelps, McNamara, P.C. (Washington, DC) Veleka R. Peeples-Dyer, Chief Legal Officer and Chief Compliance Officer, Opentrons Labworks, Inc. (Washington, DC)

• 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 10:15 AM Break 10:45 AM

8:30 AM

The Wait for A New Commissioner: Anticipating New FDA Initiatives and Policies and How They May Redefine the Life Sciences Industry in the Aftermath of COVID-19

microphone-alt

microphone-alt

David L. Rosen, Partner, Foley & Lardner LLP (Washington, DC)

Kurt R. Karst, Partner, Hyman, Phelps, McNamara, P.C. (Washington, DC)

• Distinguishing among the different FDA programs for expedited review, authorization and approval of drug products

Veleka R. Peeples-Dyer, Chief Legal Officer and Chief Compliance Officer, Opentrons Labworks, Inc. (Washington, DC)

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

At present, President Biden’s nominee for FDA Commissioner, Dr. Robert Calif is still pending, leaving open questions as to Agency priorities and initiatives.

This panel will discuss how the Agency continues to move forward despite this pending approval, its approach to COVID-19 and interim priorities.

The Pre-Approval and Approval Process 9:15 AM

Navigating the Approval Process for Drugs and Biologics

microphone-alt

Exploring FDA’s Expedited Review and Approval Programs: Applicability and Eligibility

Kinsey S. Reagan, Partner, Kleinfeld, Kaplan and Becker, LLP (Washington, DC)

• Understanding accelerated approval, surrogate and intermediate clinical endpoints • Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs • Reviewing priority review • Factoring expedited programs into your drug development strategy

Expedited Approval Case Study: From Emergency Use Authorization to Full Approval – A Closer Look at the COVID-19 Vaccine This case study will focus on the EUA, expedited approval process and other related health submissions to provide further access of the COVID-19 vaccine.

Innovator Products: New Drug Applications and Biologic License Applications

11:45 AM

1:1 Networking Break

The Drug Review Process • Reviewing the fundamentals of applications; from submission, through filing and beyond • Making sense of PDUFA Goals, fast track, break through status, and other process enhancements • Use of administrative appeals

Rx Drugs (Small Molecules)

12:00 PM Lunch Break 12:45 PM

Appreciating the Nuances of the Approval Process for Controlled Substances microphone-alt Lynn Mehler, Partner, Hogan Lovells (Washington, DC)

• Understanding the difference between “new drugs” and other drugs • Examining the research, development, and approval process for new drugs • Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)

• Defining the term “controlled substance”?

Biological Products (Large Molecules)

• Discussing the proper steps for companies who incorporate CBD’s into their products

• 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

• Reviewing the scheduling process for both approval as well as postmarketing approval with both the DEA and FDA

• 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

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

REGISTER NOW

AmericanConference.com/FDABootCamp • 1 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

1:30 PM

Clarifying the Clinical Trial Process for Drugs and Biologics

microphone-alt

Maureen Bennett, Partner, Life Sciences Co-leader for the Firm’s Health Care & Life Sciences Practice, Jones Day LLP (Boston, MA)

• 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)

• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes » Reviewing fundamentals of applications • Exploring the ANDA Paragraph IV Certification, and response to Notice Letters • Examining ANDA Standards for approval and the concepts of sameness and bioequivalence • Special considerations: local acting drugs, labeling carve outs and other nuances » Understanding the role of the Orange Book in the drug approval process

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

» Listings, de-listings and use codes • Market exclusivities and protection • Identifying the different types of exclusivities

2:30 PM Afternoon Break

» Regulatory exclusivity (FDA)/(data) exclusivity

IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More

• NCE (new chemical entity) » 5 years data exclusivity • Indication (new indication or use) » 3 years marketing exclusivity

3:00 PM

• NDF (new dosage formulation)

Part 1 – Patents and Related IP Protections and Mechanisms

microphone-alt

Jason Murata, Partner, Axinn, Veltrop & Harkrider LLP (Washington, DC)

Patent Protection for Drugs and Biologics

• ODE (orphan drug exclusivity) • PED (pediatric exclusivity)

Biologics • Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)

• Summarizing the patenting process for drugs and biologics

• Understanding the rationale for safety and efficacy concerns surrounding second generation biologics

• Strategies for building patent protection for drugs and biologics

• Exploring the concepts of “biosimilarity” or “interchangeability”

• Applying for and achieving extension of patent term for time spent in the drug approval process

• FDA rule-making and guidance relative to biosimilars

» Patent Term Extension (“PTE”)

• Other points for consideration: substitution, naming, patents, and additional nuances

» Patent Term Adjustment (“PTA”)

• Examining biosimilar exclusivities

• 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

• Deciding when to provide notice of commercial marketing 4:45 PM

Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process

microphone-alt

• 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

• “Shall we dance” — weighing the pros and cons of participating in the patent dance

Michael Hinckle, Partner, K&L Gates LLP (Washington, DC)

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

Bryan C. Diner, Partner, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

• Appreciating the influence of final labeling on the scope of post-market activities

Adam L. Perlman, Partner, Latham & Watkins LLP (Washington, DC)

• Amending labeling post-market

Drugs • Overview of Hatch-Waxman and reforms » 30-month stay; patent extensions; ANDA filer exclusivity (180 day)

6 | #FDABootCamp twitter: @ACI_Pharma

• Using labeling as a defense in products liability litigation • Exploring label carve outs • Discussing the requirements for skinny and narrow labeling 5:30 PM

Conference Adjourns to Day Two linkedin: ACI: Pharmaceutical/Biotech/Life Sciences

11:00 AM

Day Two

Thursday, March 24, 2022 (EST)

microphone-alt

8:40 AM

Co-Chairs’ Opening Remarks and Recap of Day One

microphone-alt

Kurt R. Karst, Partner, Hyman, Phelps, McNamara, P.C. (Washington, DC) Veleka R. Peeples-Dyer, Chief Legal Officer and Chief Compliance Officer, Opentrons Labworks, Inc. (Washington, DC)

cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process Seth A. Mailhot, Partner, Husch Blackwell 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 “riskbased” 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 Marc J. Scheineson, Esq., Partner, Alston & Bird LLP (Washington, DC)

• 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 10:30 AM Morning Break

REGISTER NOW

• Clarifying FDA’s current position on First Amendment and off-label promotion » The 21st Century Cures Act » FDAMA 114 • What to expect concerning proposed legislation, rules changes and Citizen Petitions

11:45 AM

8:45 AM

microphone-alt

Joel Kurtzberg, Partner, Cahill Gordon and Reindel LLP (New York, NY)

• Cases and controversies: state AG actions and private tort claims

Post Approval

microphone-alt

Part 2 – Exploring the Subtleties and Safe Zones of Off-Label Communications

Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

microphone-alt

Beth P. Weinman, Partner, Ropes & Gray LLP (Washington, DC)

• What is pharmacovigilance?

• How pharmacovigilance uses adverse event reports » Direct versus indirect reports » Causality assessments » Labeling changes

» Pre-and post-market ADE reporting requirements » 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 • Identifying risk minimization tools • Enforcing ADE reporting and REMS requirements • 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 » Market withdrawals and stock recoveries

» Voluntary recalls versus mandatory recalls

• Interaction between recalls and corrective and preventive action 12:45 PM

Understanding the Scope of FDA Enforcement Authority and Actions

microphone-alt

Jennifer L. Bragg, Partner, Skadden LLP (Washington, DC) John Fuson, Partner, Crowell & Moring LLP (Washington, DC)

• 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 » Form FDA 483 observations • For cause inspections vs. » Untitled and Warning Letters routine inspections • Related to inspections • Communication with the • Resulting from nonFDA during inspections inspection data or » EIRs information • Examining enforcement actions related to digital advertising and social media 1:30 PM

Main Conference Ends AmericanConference.com/FDABootCamp • 1 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Post-Conference Workshop Thursday, March 24, 2022 (EST)

WORKSHOP C

clock 2:00 PM – 5:30 PM

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

Emily R. Whelan, Partner, WilmerHale (Boston, MA) Jonathan B. Roses, Counsel, Wolf, Greenfield & Sacks, P.C. (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 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.

Related Conference

5th Annual Summit on

CONTROLLED SUBSTANCES REGULATION, LITIGATION, AND ENFORCEMENT

 Join Our Email List to Stay Connected Sign up to receive exclusive discounts, offers and program updates.

AmericanConference.com/join-our-email-list/

About us:

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

For over 30 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

8 | #FDABootCamp twitter: @ACI_Pharma

linkedin: ACI: Pharmaceutical/Biotech/Life Sciences

Map Out Your Virtual Experience.

True Interaction from Start to Finish.

The Lobby is your starting point…

View the Schedule See What is “Happening Now”

FILE-PDF

Access Conference Materials Accreditation Information

HANDSHAKEHANDSHAKE

Check Out Our Sponsors

The Sessions area contains the majority of the conference programming and networking events.

The 1:1 Networking is a fast-paced opportunity to meet new people and expand your professional network.

Plan to visit the Expo often.

It will be open before, during, and after the conference.

CHEVRON-DOUBLE-RIGHT Attend live sessions, ask questions, comment in the chat function, and take part in live polling.

Enter this area to be paired up at random with other attendees for a quick video meet-up.

Use this opportunity to explore new products and services from leading providers, and meet with new and existing partners over video chat.

View Related Conferences

Emma McAdam VP, Government Affairs

Janet Smith VP, General Counsel

Olivia Thomson Chief Compliance Officer

Luis Santos Director

Ramesh Kumar Partner

Jean Roux VP, Business Development

CO-CHAIRS

DISTINGUISHED CO-CHAIRS

Patricia Harden Head of Sanctions Miyuki Johnson VP, Manufacturing

Kurt R. Karst Brennan Torregrossa Partner Senior ViceHyman, President, Head & ofMcNamara, Global Litigation Phelps P.C. GSK

Veleka R. Peeples-Dyer Lisa Dunkin Partner; Chair, North America Assistant General Food and DrugCounsel, PracticeLitigation Biomet BakerZimmer McKenzie LLP

Maximize Your Conference Experience

Update your profile

Review your profile, upload a picture and connect your social media accounts to personalize your presence.

People tab

You can also engage with other attendees directly. Find a person in the attendee list to send a message and/or an invitation to a video chat.

Polling

Weigh in and seize the opportunity to benchmark with industry peers in real-time.

Use the Chat feature to engage with fellow attendees, speakers and sponsors.

Turn your camera on

for roundtable sessions, networking events and video chats for a more engaging virtual connection.

Make Connections Join scheduled “1:1 Networking” sessions. They are an interactive way to expand your network of peers.

REGISTER NOW

Engage with solution providers of all kinds by visiting the “Expo” to watch videos and live demonstrations, and for face-to-face conversations.

AmericanConference.com/FDABootCamp • 1 888 224 2480

Use the “People” tab to create new relationships and strengthen existing ones within your industry.

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Mark Parrish American Conference Institute

Looking to Register?

Contact our Customer Service Representatives:

Daniel Manganiello American Conference Institute



M.Parrish@AmericanConference.com



D.Manganiello@AmericanConference.com



1 212 352 3220 x7207



1 212 352 3220 x5464

Use Registration Code: B00-999-MPH22

Use Registration Code: B00-999-DMO22

SAVE $200

SAVE $100

Register & Pay by January 14, 2022

Register & Pay by February 11, 2022

Register & Pay after March 4, 2022

ALL ACCESS PASS*

$2295

$2395

$2495

Virtual Conference

$1595

$1695

$1795

PRICING

Program + All Three Workshops

Workshops

CONFERENCE CODE:

874L22-NYC

Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.

$400 each

All program participants will receive an online link to access the conference materials and recordings as part of their registration fee.

Additional copies of the Conference Materials available for $199 per copy.

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/.

Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/

Bringing a Team?

10% Discount

Teams of 5+ Call

888-224-2480

for Teams of 3–4*

*Team/group registrations must be from the same organization/firm and register together in one transaction.

hands-helping BECOME A SPONSOR With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@ AmericanConference.com

© American Conference Institute, 2021

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

EARN CLE/ETHICS

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-forvirtual-attendance/