ACI's 36th FDA Boot Camp New York Edition - WEB

EXPLORE THE NEW VIRTUAL EXPERIENCE FOR 2021 No Need to Travel. Connect with Your Peers Virtually.

EARN CLE/ETHICS CREDITS

American Conference Institute’s 36 th

March 24-25, 2021 (EDT)

Virtual Conference

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

Special Focus Sessions on: ĉ Expedited Approvals: Chasing the COVID-19 Vaccine

Co-Chairs

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

Torrey Cope Partner Sidley Austin LLP

ĉ Controlled Substances

Join us for Pre- and Post-Conference Workshops: March 23, 2021:

A | FDA Law 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

B | Medical Devices, Combination Products, and

Companion Diagnostics Boot Camp: A Guide to FDA Guidelines and Regulations March 25, 2021:

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 CHEVRON-RIGHT MASTER the basics of the application and approval processes for drugs and biologics CHEVRON-RIGHT APPRECIATE the complexities of pharmaceutical IP and the regulatory 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 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 regulatory process CHEVRON-RIGHT NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls

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

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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

No Need to Travel. We are Coming to You Virtually this March.

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 36th 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.

Learn from the Masters 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 role of the Hatch-Waxman Act in the patenting of drugs and biologics

ĉ The essentials of the approval process for drugs ĉ Labeling in the drug and biologics approval and biologics process ĉ Clinical trials for drugs and biologics

ĉ Proactive adverse events monitoring and signal detection ĉ Recalls, product withdrawals, and FDA oversight authority

ĉ cGMPs and other manufacturing concerns relative to products liability

Boost your FDA regulatory IQ: From Pre-Approval through Post-Approval In addition, our updated agenda offers advanced guidance sessions focusing on expedited approvals in view of the search for a COVID-19 vaccine and an introduction to controlled substances.

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

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

Take advantage of the All Access Pass to attend all 3 days with one low rate. Register now to receive the best rates!

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C5 GROUP’S VIRTUAL EVENTS

Join Us Virtually this March!

As the current global situation continues to unfold, we understand that it may not be possible to attend our events in person.

At the same time, we also understand that collaboration is more vital than ever and for that, you can still rely on ACI to bring the industry together but in a different way. We are transforming quickly to ensure you can now connect virtually and continue to gain unparalleled access to market leading intelligence and to the facilitation of a global exchange of expertise.

Our new virtual events continue to be guided by our unifying philosophy: we believe that growth and success occurs when the power of people and the power of information come together. We may not be able to gather in person, but nothing stops connection and innovation.

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 For more information and answers to many of your questions, please visit:

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2021 Faculty List

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Co-Chairs Kurt R. Karst Partner Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

Torrey Cope Partner Sidley Austin LLP (Washington, D.C.)

Distinguished Speakers Maureen Bennett Partner, Life Sciences Co-leader for the Firm’s Health Care & Life Sciences Practice Jones Day LLP (Boston, MA) Bryan C. Diner Partner Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC) Denise Esposito Partner Covington & Burling LLP (Washington, DC) Chalana N. Damron Counsel Crowell & Moring LLP (Washington, DC) Bryant M. Godfrey Counsel Arnold & Porter (Washington, DC) Karin Hessler Assistant General Counsel Association for Accessible Medicines (Washington, DC)

4 | #FDABootCamp twitter: @ACI_Pharma

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

Stephanie Philbin Partner Goodwin Procter LLP (Washington, DC)

Chad Landmon Partner Axinn, Veltrop & Harkrider LLP (Washington, DC)

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

Seth A. Mailhot Partner Husch Blackwell LLP (Washington, DC)

Jonathan B. Roses Counsel Wolf, Greenfield & Sacks, P.C. (Boston, MA)

Lynn Mehler Partner Hogan Lovells (Washington, DC) Christopher Mikson Partner DLA Piper LLP (Washington, DC) Neil O’Flaherty Partner Amin Talati Wasserman LLP (Chicago, IL) Adam L. Perlman Partner Latham & Watkins LLP (Washington, DC)

linkedin: ACI: Pharmaceutical/Biotech/Life Sciences

Kathleen M. Sanzo Partner Morgan, Lewis & Bockius LLP (Washington, DC) Marc J. Scheineson, Esq. Partner Alston & Bird LLP (Washington, DC) Emily R. Whelan Partner WilmerHale (Boston, MA)

Pre-Conference Workshops • Tuesday, March 23, 2021 EDT Workshop A | 9:00 AM – 12:00 PM (10:30 AM – 11:00 AM Break) + 1 HOUR ETHICS Bonus

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 • 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

• FDA’s policies and procedures • 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 | 1:30 PM – 4:30 PM (2:30 PM – 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 (Chicago IL)

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

Companion Diagnostics

• 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

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• Exploring the regulations of laboratory developed tests (LDTs) • Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs • Utilizing companion diagnostics via smart technologies

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CONTINUING LEGAL EDUCATION CREDITS EARN CLE/ETHICS

Accreditation will be sought in those jurisdictions requested CREDITS 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 by the State Bar of California for 20.0 CLE credit, including 1.0 CLE credit hour dedicated to ethics during Workshop A. 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/

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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Day 1

Rx Drugs (Small Molecules)

Wednesday, March 24, 2021 EDT

• 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)

8:15 AM

Co-Chairs’ Opening Remarks microphone-alt

Kurt R. Karst, Partner, Hyman, Phelps, McNamara, P.C. (Washington, DC) Torrey Cope, Partner, Sidley Austin LLP (Washington, DC)

8:30 AM

Understanding the Relevance of New FDA Initiatives and Policies and How They May Redefine the Life Sciences Industry in the Aftermath of COVID-19 microphone-alt

Kurt R. Karst, Partner, Hyman, Phelps, McNamara, P.C. (Washington, DC) Torrey Cope, Partner, Sidley Austin LLP (Washington, DC)

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 the public to 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

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

• 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 Break

Review and Approval 10:30 AM

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

Innovator Products: New Drug Applications and Biologic License Applications The Drug Review Process

microphone-alt

• 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

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Biological Products (Large Molecules)

Denise Esposito, Partner, Covington & Burling LLP (Washington, DC)

• Distinguishing among the different FDA programs for expedited review and approval of drug products • Evaluating the criteria for eligibility, benefits, and limitations of each program

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• 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

Case Study: 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.

11:45 AM

1:1 Networking Break Make new connections, face-to-face by using an interactive virtual feature that will introduce you to fellow industry peers for a quick conversation.

11:55 AM Lunch Break 12:45 PM

Appreciating the Nuances of the Approval Process for Controlled Substances microphone-alt

Lynn Mehler, Partner, Hogan Lovells (Washington, DC)

• Defining the term “controlled substance”?

• Reviewing the scheduling process for both approval as well as post-marketing 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

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) • Enforcement • Review of the “Right to Try” laws and their requirements during the clinical trials process 2:30 PM 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)

Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP (Washington, DC)

Patent Protection for Drugs and Biologics • Summarizing the patenting process for drugs and biologics • Strategies for building patent protection for drugs and biologics • Applying for and achieving extension of patent term for time spent in the drug approval process » Patent Term Extension (“PTE”) » Patent Term Adjustment (“PTA”) • 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

Biologics

• Overview of selecting a brand name for a proposed drug product

• 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

• 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, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Adam L. Perlman, Partner, Latham & Watkins LLP (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 • 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 » 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)

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• Deciding when to provide notice of commercial marketing 5:00 PM

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

Seth A. Mailhot, Partner, Husch Blackwell 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 • Appreciating the influence of final labeling on the scope of postmarket activities • Amending labeling post-market • Using labeling as a defense in products liability litigation • Exploring label carve outs • Discussing the requirements for skinny and narrow labeling 5:45 PM

Conference Adjourns to Day 2 – 30-minute Meet and Greet with Speakers

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Day 2

Thursday, March 25, 2021 EDT 8:30 AM

Co-Chairs’ Opening Remarks and Recap of Day 1 microphone-alt

Kurt R. Karst, Partner, Hyman, Phelps, McNamara, P.C. (Washington, DC) Torrey Cope, Partner, Sidley Austin LLP (Washington, DC)

Post Approval 8:45 AM

cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process microphone-alt

10:30 AM Break

Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius 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

Part 1 – Drug and Biologics Advertising and Promotion 101 Marc J. Scheineson, Esq., Partner, Alston & Bird LLP (Washington, DC)

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

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

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

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

Stephanie Philbin, Partner, Goodwin Procter LLP (Washington, DC)

• What is pharmacovigilance?

• 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

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11:00 AM

11:45 AM

9:45 AM

microphone-alt

• 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

• How pharmacovigilance uses adverse event reports » Direct versus indirect » Pre-and post-market ADE reports reporting requirements » Causality assessments » How regulatory agencies use ADE reports » Labeling changes

linkedin: ACI: Pharmaceutical/Biotech/Life Sciences

• 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 » Voluntary recalls versus regulation mandatory recalls » Market withdrawals and stock recoveries • Interaction between recalls and corrective and preventive action 12:45 PM

Understanding the Scope of FDA Enforcement Authority and Actions microphone-alt

Bryant M. Godfrey, Counsel, Arnold & Porter (Washington, DC) Chalana N. Damron, Counsel, 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 » Untitled and Warning Letters • For cause inspections vs. routine inspections • Related to inspections • Communication with the FDA during • Resulting from noninspections inspection data or » EIRs information » Form FDA 483 observations • Examining enforcement actions related to digital advertising and social media 1:45 PM

Main Conference Ends

Post-Conference Workshop • Friday, March 25, 2021 EDT Workshop C | 2:45 PM – 6:15 PM (4:00 PM – 4:30 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)

About us:

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

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.

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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