RIC 2026 Annual Meeting

 

Event Schedule: Wednesday, March 11, 2026

8:00 AM - 5:00 PM

Registration Open

Location: Prefunction A

Stop by the registration desk on the 2nd floor Prefunction to grab your name badge and meeting materials!

8:00 AM - 9:00 AM

Breakfast & Industry Partner Tabletop Exhibits

Location: Fitzgerald AB / Prefunction

Join us for a great start to the day! Explore innovative products and solutions from RIC's 2026 Industry Partners.

9:00 AM - 9:15 AM

Welcome and Opening Remarks

Location: Fitzgerald CDE

Speakers: Kevin Holman (Johnson & Johnson)

9:15 AM - 10:15 AM

KEYNOTE

REMS at a Crossroads: What Real-World Practice Tells Us About Bispecific Safety

Location: Fitzgerald CDE

Speaker: Zahra Mahmoudjafari (The University of Kansas Cancer Center)

10:15 AM - 10:30 AM

Morning Coffee Break

Location: Prefunction

10:30 AM - 11:30 AM

INTERACTIVE SESSION

Inspect This! A Live REMS Inspection Readiness White Paper Session

Location: Fitzgerald CDE

Facilitators: Kal Elhoregy, Jacqueline Gerena, Michele Coiro, Eleni Allen, Leonora Almeida, Kyle Irwin

11:30 AM - 12:00 PM

RIC Membership Business Meeting

Location: Fitzgerald CDE

12:00 PM - 1:00 PM

Lunch

Location: Fitzgerald AB

1:00 PM - 2:00 PM

2026 Federal Landscape

Location: Fitzgerald CDE

Speaker: Michael Strazzella (Buchanan Ingersoll & Rooney)

2:00 PM - 3:00 PM

Concurrent Sessions (Select One)

  • Fireside Chat: Global Risk Management
    Speakers: Jamie Wilkins, Carmit Strauss | Moderator: Jacqueline Gerena
  • REMS Challenges: Identifying Solutions Together
    Speakers: Suzanne Marinello, Chirag Sheth
3:00 PM - 3:15 PM

Afternoon Coffee Break

Location: Prefunction

3:15 PM - 4:15 PM

Concurrent Sessions (Select One)

  • FDA-Required REMS Stakeholder Audits: Effective Compliance
    Panelists: Matt Wright, Nichole Johnson, Erin Movall | Moderator: Jacqueline Gerena
  • Leveraging AI in REMS: Insights and Applications
    Speaker: Kyle Irwin | Moderator: Eleni Allen
4:15 PM - 5:15 PM

Fireside Chat: FDA Guidance and Interaction Strategies on the REMS Logic Model

Location: Fitzgerald CDE

Speakers: Laura Zendel (FDA), Sevan Kolejian (FDA)

5:15 PM - 5:30 PM

Award Presentation and Day 1 Wrap Up

REMS Bingo winners announced! Must be present to win.

5:30 PM - 7:30 PM

Evening Reception

Location: Prefunction

Unwind and network with refreshments and hors d'oeuvres.

 

 

 

Event Schedule: Thursday, March 12, 2026

8:00 AM - 12:00 PM

Registration Open

Location: Prefunction A

[cite: 232, 233]

8:00 AM - 9:00 AM

Breakfast Buffet

Location: Fitzgerald AB

Join us for a warm and welcoming start to the final day!

[cite: 235, 236, 237]

8:00 AM - 1:00 PM

INDUSTRY PARTNERS

Industry Partner Tabletop Exhibits Open

Location: Prefunction

Explore innovative tools and services, ask questions, and connect one-on-one with solution providers who support REMS.

[cite: 238, 239, 242, 243]

9:00 AM - 9:30 AM

GENERAL SESSION PANEL

How AI Can Help Navigate Challenges with Shipping to REMS-Certified Facilities

Location: Fitzgerald CDE

Speakers: Jennifer Reinert (Pfizer Inc.), Keegan Chamberlain (Cardinal Health), Amanda Moore (Cardinal Health), Jessy Mathews (Cardinal Health)

[cite: 244, 245, 246, 255, 260, 265, 271]

9:30 AM - 10:30 AM

GENERAL SESSION PANEL

Panel Discussion: Insights from (Former) Insiders

Location: Fitzgerald CDE

Moderator: Claudia Manzo (AbbVie)

Panelists: Elaine Lippmann (Leavitt Partners), Jamie Wilkins (Pfizer Inc.), Gita A. Toyserkani (Regulatory Strategy Lead)

[cite: 277, 278, 279, 281, 286, 291, 295]

10:30 AM - 10:45 AM

Morning Coffee Break

Location: Prefunction

[cite: 300, 306]

10:45 AM - 11:30 AM

GENERAL SESSION

RIC Working Group Updates

Location: Fitzgerald CDE

Key insights into ongoing projects and future goals of RIC Working Groups.

[cite: 307, 308, 309, 311]

  • FDA Working Group Update: Claudia Manzo (10:45 AM - 10:55 AM)

[cite: 313, 314, 315]

  • Communications Working Group Update: Jacqueline Gerena, Leonora Almeida (10:55 AM - 11:05 AM)

[cite: 316, 317, 318]

  • Innovation & Technology Working Group Update: Kyle Irwin (11:05 AM - 11:15 AM)

[cite: 319, 320, 321]

  • Education/Certification Working Group Update: Michele Coiro, Liza Rodriguez (11:15 AM - 11:25 AM)

[cite: 322, 323, 324]

11:30 AM - 12:00 PM

GENERAL SESSION INDUSTRY PARTNERS

Real World Examples in AI Technology Advancements in REMS Technology Rapid Fire

Location: Fitzgerald CDE

[cite: 325, 326, 327]

  • Shepherd Safety Solutions: Melissa Landers

[cite: 336, 337, 338]

  • Syneos Health: Nikki Walters

[cite: 339, 340, 341]

  • UBC: Haresh Patel, Pieter Wilcocks

[cite: 342, 343, 344]

12:00 PM - 1:00 PM

Lunch

Location: Fitzgerald AB

[cite: 345, 346]

1:00 PM - 2:00 PM

GENERAL SESSION

REMS Integration and Innovation Project Updates

Location: Fitzgerald CDE

Speaker: Edward Millikan (FDA)

[cite: 348, 349, 350, 354]

2:00 PM - 3:00 PM

KEYNOTE

Closing Keynote - The Predictability Premium: Building Stable Ground for REMS

Location: Fitzgerald CDE

Speaker: Elaine Lippmann (Leavitt Partners)

An examination of how regulatory volatility and shifting policy channels are reshaping the REMS landscape.

[cite: 356, 357, 358, 366, 371]

3:00 PM - 3:15 PM

RIC 2026 Annual Meeting Wrap Up

Location: Fitzgerald CDE

Final acknowledgments, collaborative highlights, and announcement of Bingo and Trivia winners!

[cite: 374, 375, 376, 378]