FDA BOOT CAMP

September 20–21, 2023 | Boston, MA

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

Distinguished Conference Chairs:

Join us for Pre and Post Conference Workshops:

Pre-Conference Workshop A (with 1 hour Ethics Bonus)

FDA 101: 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

Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you:

• COMPREHEND the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR

• MASTER the basics of the application and approval processes for drugs and biologics

• APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products

• GAIN a practical working knowledge of clinical trial process for pharmaceutical products

• RECOGNIZE the pivotal role of labeling in the drugs and biologics approval process

• DECIPHER the requirements for the advertising, marketing, and promotion of drugs and biologics

• UNDERSTAND the importance of cGMPs to the post-approval regulatory process

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 — including Reforms under FDORA — 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 FDAregulated products to have a familiarity with these concepts.

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:

• The organization, jurisdiction, functions, and operations of FDA

• The essentials of the approval process for drugs and biologics plus insights on accelerated approvals under FDORA

• Clinical trials for drugs and biologics including diversity updates under FDORA

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

• Labeling in the drug and biologics approval process

• cGMPs and other manufacturing concerns relative to products liability

• Proactive adverse events monitoring and signal detection

• Recalls, product withdrawals, and FDA oversight authority

For nearly two decades, 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.

We look forward to seeing you in Boston this September!

DISTINGUISHED CO-CHAIRS

Torrey Cope Partner

Sidley Austin (Washington, DC)

Distinguished Speaker Faculty

Maureen Bennett

Partner, Life Sciences Co-leader for the Firm’s Health Care & Life Sciences Practice

Jones Day LLP (Boston, MA)

Delia Deschaine

FDA/DEA Regulatory Attorney - Member of the Firm (Partner)

Epstein Becker & Green, P.C. (Washington, DC)

Bryan C. Diner Partner

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

Maya P. Florence Partner

Skadden, Arps, Slate, Meagher & Flom LLP (Boston, MA)

Joel Kurtzberg Partner

Cahill Gordon & Reindel LLP (New York, NY)

Seth A. Mailhot Partner

Husch Blackwell LLP (Washington, DC)

Christopher Mikson Partner

DLA Piper LLP (Philadelphia, PA)

Marc J. Scheineson Partner

Alston & Bird LLP (Washington, DC)

Global Sponsorship Opportunities

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: American Conference Institute SponsorInfo@AmericanConference.com

Kurt R. Karst Partner

Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

Beth Weinman Counsel

Ropes & Gray LLP (Washington, DC)

James William Woodlee Partner

Kleinfeld, Kaplan & Becker, LLP (Washington, DC)

John Fuson Partner

Crowell & Moring LLP (Washington, DC)

Evan Phelps Partner

Amin Talati Wasserman (Washington, DC)

Jonathan B. Roses Counsel

Wolf, Greenfield & Sacks, P.C. (Boston, MA)

Emily Whelan Partner

WilmerHale (Boston, MA)

Alexandra D. Valenti Partner

Goodwin Procter LLP (Washington, DC)

Benjamin Zegarelli Of Counsel

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (New York, NY)