Agenda

11:30 AM — Registration & Networking

1:30 PM — Opening Remarks

1:35 PM — Rapid Fire Innovation Spotlight

1:50 PM — CDISC TMF Standard V1: Are You Ready?

• Presented by Gillian Gittens - Senior Director, e-Clinical Strategy & Solutions, TransPerfect

2:35 PM — Inspection War Stories

• Hosted by Avani Amin - Director, Client Solutions, TransPerfect

Featured Speakers:

• Debra Curtis - Director & Head of TMF Operations, Amgen
• Istvan Kerekes - Senior Clinical Project Manager, Gedeon Richter
• Marleen Luten - eClinical Software Administrator, HOVON

3:05 PM — Rapid Fire Innovation Spotlight

3:20 PM — Coffee Break

3:40 PM — M&A and Migrations

• Hosted by Avani Amin - Director, Client Solutions, TransPerfect

Featured Speakers:

• Veronica Martin - Head of CDM External TMF Operations, CDGM, Novartis
• Debra Curtis - Director & Head of TMF Operations, Amgen
• Vanessa Gonzalez - Strategy & Transformation Advisor, Global Quality R&D, Eli Lilly

4:10 PM — Rapid Fire Innovation Spotlight

4:25 PM — End of Study Reconciliation & Archiving

• Hosted by Cfyn Markwick-Day - Director, Business Development, TransPerfect

Featured Speakers:

• Ida Olsen - Clinical Trial Assistant Specialist, ALK-ABELLÓ A/S
• Chris Jones - Head of CDM Business Operations, CDGM, Novartis
• Nina Louise Arberg - Senior Clinical Document Manager, Ferring Pharmaceutical

4:55 PM — Rapid Fire Innovation Spotlight

5:10 PM — AI in eClinical: Now & the Future

• Hosted by Christopher Utterback - Regional Director, Life Sciences, TransPerfect

Featured Speakers:

• Mof Osei - Head of Clinical Documentation, GSK
• Martina Duevel - Independent Consultant
• Olivia Howard - Director, Clinical Operations, Scancell

5:40 PM — Rapid Fire Innovation Spotlight

6:00 PM — Networking Cocktail

7:00 PM — Evening Social Event

Please note that the agenda is subject to change, and this page will update as more details become available.

9:00 AM — Networking

10:00 AM — TransPerfect NEXT Opening Remarks

• Presented by Matt Hauser - Chief Experience Officer, TransPerfect

10:45 AM — Keynote Address

12:00 PM — Lunch

1:00 PM — Owning the System: The Advantages of Interoperability

• Hosted by Michael Smyth - Division President, Trial Interactive, TransPerfect

Featured Speakers:

• Julia DeCesare - Senior Director, Clinical Operations, T-Therapeutics
• Samantha Dijkxhoorn-Young - eClinical Software Administrator, HOVON
• Martina Duevel - Independent Consultant
• Danny Nasmyth-Miller - Independent Consultant
• Javier Dominguez - IT Director, Applications R&D, Grifols

1:45 PM — Risk Based Oversight: Roles & Responsibilities

• Hosted by Pooja Brahmbatt - TMF Project Manager, TransPerfect

Featured Speakers:

• Istvan Kerekes - Senior Clinical Project Manager, Gedeon Richter
• Karla Navera-Andersen - Senior eTMF Manager, Zealand Pharma
• Olivia Howard - Director, Clinical Operations, Scancell

2:15 PM — Rapid Fire Innovation Spotlight

2:30 PM — Ask a CRO: Easing Sponsor Collaboration

• Hosted by Graham Downing - VP of Biometrics, MAC Clinical

Featured Speakers:

• Stacey Carruthers - Trial Management & Monitoring Lead, Protas
• Karla Navera-Andersen - Senior eTMF Manager, Zealand Pharma
• Ida Olsen - Clinical Trial Assistant Specialist, ALK-ABELLÓ A/S
• Helen Price - Executive Director, Central Records & Document Management, Worldwide Clinical Trials

3:15 PM — Inspection Expectations in 2027 and Beyond

• Hosted by Gillian Gittens - Senior Director, e-Clinical Strategy & Solutions, TransPerfect

Featured Speakers:

• Istvan Kerekes - Senior Clinical Project Manager, Gedeon Richter
• Marleen Luten - eClinical Software Administrator, HOVON
• Nina Louise Arberg - Senior Clinical Document Manager, Ferring Pharmaceutical

3:55 PM — Closing Remarks

Please note that the agenda is subject to change, and this page will update as more details become available.