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New York/New Jersey Area Chapter Workshop: Applying Generative AI Responsibly in Regulatory Affairs

Join expert speakers and seasoned professionals for an all-day, hands-on workshop where you’ll explore real-world applications of Artificial Intelligence from analysis in support of regulatory intelligence to building custom GPTs and crafting effective prompts. You’ll learn how to identify risks, avoid common pitfalls, and future-proof your RA skill set in a rapidly evolving landscape.

Join expert speakers and seasoned professionals for an all day, hands-on workshop where you’ll explore real-world applications of Artificial Intelligence from analysis in support of regulatory intelligence to building custom GPTs and crafting effective prompts. You’ll learn how to identify risks, avoid common pitfalls, and future-proof your RA skill set in a rapidly evolving landscape.

All participants should bring fully charged laptops with the latest free versions of either Microsoft Co-Pilot or Google Gemini downloaded. Wi-Fi will be provided.

This onsite workshop is being hosted by Indegene at their Princeton, NJ location directly off of Route 1.

Agenda

Time Objective
8:00 AM – 9:00 AM

Continental Breakfast and Networking

9:00 AM – 9:15 AM

Welcome & Opening Remarks 

9:15 AM – 10:15 AM

Generative AI Fundamentals for Regulatory Professionals

10:15 AM – 11:15 AM

High‑Value Use Cases in Regulatory Affairs

11:15 AM – 11:30 AM

Break

11:30 AM – 12:30 PM

Practical use cases across regulatory intelligence, submissions, labelling, and quality checks

12:30 PM – 1:30 PM

Lunch & Informal Discussion

1:30 PM – 2:00 PM

Practitioner Perspective: GenAI in Real‑World Regulatory Practice

2:00 PM – 3:00 PM

Case Study Lab — Precedent Research with GenAI

3:00 PM – 3:30 PM

Panel Discussion: The Future of Regulatory Affairs in the Age of AI

3:30 PM – 4:00 PM

Closing Session — Key Takeaways & Action Planning

Location

Indegene
150 College Road West
Suite 104
Princeton, NJ 08540

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].  

Speakers

Clapton  Dias

Clapton Dias

Former Senior Vice President Global R&D Strategy, Portfolio, and Hubs EMD Serono, Inc., Private Consultant

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Leslie  Kitchen

Leslie Kitchen

Senior Director – Hyper Automation, AI & Strategic Innovation Management, Merck Inc.

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Vladimir  Penkrat

Vladimir Penkrat

Associate Vice President, Regulatory Affairs, Indegene

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Lincy  Jaison

Lincy Jaison

Senior Manager, Indegene Academy, Indegene

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Nikesh  Shah

Nikesh Shah

Head of R&D Generative AI, Indegene

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Tarun  Mathur

Tarun Mathur

Chief Technology Officer, Indegene

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