14th Annual
PHARMACEUTICAL REGULATORY OPERATIONS & SUBMISSIONS CONFERENCE
September 22-23, 2026 | Boston, MA
Courtyard by Marriott Boston Cambridge
Navigating Transitions to eCTD 4.0 While Implementing AI Technologies & Efficiently Submitting Compliant Global Submissions
Distinguished Presenters Include:
Dikran Toroser
Founding Faculty
UCSD
Sonal Mazumder, PhD
Senior Manager, Regulatory Affairs CMC
AADI BIOSCIENCES
Sarah Thompson Schick
Partner
REED SMITH LLP
Keith Weber
Director, Global Submission Publishing
MERCK
Francis Quinn
Director Submission Management
Pfizer
Heather Sinsel
Principal
MOMENTUM REGULATORY
John C. Balzano
Partner
COVINGTON & BURLING
Geon Yi
Associate Director, Global Submission Publishing
MERCK
Olga Alfieri
Associate Director, Global Submissions Management
EISAI PHARMACEUTICALS
Srinivas Kommalapati
CEO
MUSHROOM SOLUTIONS
Milan Shah
Head, Document Publishing Solutions, Regulatory Submission Management & Operations
JOHNSON AND JOHNSON
Countdown to the Pharmaceutical Regulatory Operations & Submissions Conference
Day(s)
:
Hour(s)
:
Minute(s)
:
Second(s)
Agenda – Day One
Tuesday, September 22
8:30 REGISTRATION & WELCOME COFFEE
9:20 CHAIRPERSON’S OPENING REMARKS
9:30 OPENING ICE BREAKER: SUCCESSES AND CHALLENGES OF CMC OPERATIONS
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange perspectives on the daily challenges of submission operations, discussing challenges associated with the evolution of the regulatory operations role and regulations. Furthermore, participants in this warm-up session are also given the opportunity to directly build contacts.
10:00 SMALL GROUP DISCUSSION: DETERMINING WHEN TO OUTSOURCE PUBLISHING RESPONSIBILITIES
With the consideration of increased responsibilities and expectations placed upon regulatory operations and submissions executives as the role is modernized, one key aspect of retaining necessary bandwidth internally is to contract out certain tasks, such as publishing, to third party vendors. This interactive discussion will break the audience into groups based on company size to discuss the likelihood and potential factors when deciding whether it would be beneficial to outsource these duties.
GROUP ONE: START UP & SMALL-CAP COMPANIES
GROUP TWO: MID-CAP COMPANIES
GROUP THREE: LARGE-CAP COMPANIES
Dikran Toroser, Founding Faculty
UCSD
10:45 COFFEE & NETWORKING BREAK
11:30 ICH GUIDANCE DOCUMENT ON M4Q R2 CTD UPDATES FOR COMPLIANCE
• Reforming Module 2 to become focal point for submissions
• Ensuring comprehensive reference documents in Module 3
• Adherence to new Modules 2 and 3 for lifecycle management
Sonal Mazumder, PhD, Senior Manager, Regulatory Affairs CMC
AADI BIOSCIENCES
12:15 LUNCHEON
1:30- 3:00 SESSION SERIES: TIMELINE AND DATA REQUIREMENT FOR COMPLETE SUBMISSIONS ON A GLOBAL SCALE
As the focus of many notified bodies and pharmaceutical manufacturers continues to move towards the global perspective, it remains imperative that executives stay abreast of nuances distinct to those regions that affect regulatory operations and submissions. This session series will provide in depth looks at the regulatory requirements and associated deadlines to ensure proper and complaint submissions when including these areas to a global submission checklist.
1:30 UNITED KINGDOM & AUSTRALIA
Olga Alfieri, Associate Director, Global Submissions Management
EISAI PHARMACEUTICALS
2:15 CHINA
John C. Balzano, Partner
COVINGTON & BURLING
3:00 COFFEE & NETWORKING BREAK
3:30 RegX™: The Intelligent AI-Powered Digital Co-Worker for Next-Generation Regulatory Operations.
• Optimize end-to-end regulatory operations with RegX™, an advanced AI-driven intelligence and automation platform that seamlessly integrates regulatory information management, submission planning, document management, content authoring, eCTD publishing, and HA submissions.
• Modernize regulatory operations through intelligent automation and seamless human-AI collaboration, while maintaining appropriate human oversight, strengthening compliance, governance, traceability, and regulatory excellence.
• Empower regulatory teams with AI-powered digital co-workers to automate manual and complex activities, accelerate execution and submissions, enhance accuracy, improve productivity, and increase process efficiency across the regulatory lifecycle.
• Build a modern, connected and scalable regulatory ecosystem that integrates with existing regulatory and enterprise systems, drives operational excellence, and enables regulatory organizations to efficiently adapt to the evolving life sciences regulations and global market requirements.
Srinivas Kommalapati, CEO
MUSHROOM SOLUTIONS
4:15 ADOPTION STRATEGIES FOR FDA DIGITAL SUBMISSIONS & PLATFORMS
• Transitioning to FAERS digital submissions by deadline
• Utilization of new ESG NextGen modernized platform
• High-security Elsa AI tool for optimizing internal searches
Heather Sinsel, Principal
MOMENTUM REGULATORY
5:00 CLOSING REMARKS AND END DAY ONE
Agenda – Day Two
Wednesday, September 23
8:30 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 MAXIMIZING DOCUMENTATION REUSE IN SUPPORT OF GLOBAL DOSSIER SUBMISSIONS
• Templates and frameworks for increasing document utilization
• Focuses on eCTD 4.0 global standards versus regional standards
• Considerations for varied electronic data submission requirements
9:45 DISCUSSION – PREPARING FOR IMPLEMENTATION AND MANAGEMENT OF ECTD 4.0 COMPLIANT SUBMISSIONS
• Foundations for seamless in-house transitions to eCTD 4.0
• Overseeing outsourced responsibilities for eCTD 4.0 updates
• Preventative measures to mitigate arising setbacks in adapting
• Metadata clean up in preparation for eCTD 4.0 submissions
Keith Weber, Director, Global Submission Publishing
MERCK
Geon Yi, Associate Director, Global Submission Publishing
MERCK
10:30 COFFEE & NETWORKING BREAK
11:00 PANEL DISCUSSION: ENSURING EFFICIENCY AND EFFECTIVENESS WITH REMOTE TEAM MEMBERS
• Recognizing efficiencies made possible by each work format
» In-person
»Remote
• Organization of hybrid schedules according to team strengths
• Stable and ongoing communication for high level cooperation
• Continuous adjustments as needed to support team goals
Francis Quinn, PFIZER
Olga Alfieri, EISAI PHARMACEUTICALS
11:45 INTERACTIVE OPEN FORUM Q&A ROUND ROBIN
This interactive open forum is designed to foster candid discussion and peer-to-peer exchange on the most pressing challenges and emerging trends facing the industry today. Participants are invited to bring forward questions, insights, and real-world experiences for an open Q&A with subject-matter experts and fellow attendees. The session will provide a collaborative space to explore practical solutions, share lessons learned, and address unresolved issues that may not be covered in formal presentations, encouraging active engagement and meaningful dialogue across diverse perspectives.
12:15 LUNCHEON
1:30 LEGAL PERSPECTIVE: ASSESSING RISKS AND LEGAL COMPLIANCE WHEN INSTITUTING AI USE
• Minimizing cybersecurity risks through closed AI systems
• Nuances for complying with IP and copyright requirements
• FDA guidance review on AI to support regulatory decisions
Sarah Thompson Schick, Partner
REED SMITH LLP
2:15 GROUP DISCUSSION WORKSHOP: ASSESSMENT OF PRO VS CONS OF AI IMPLEMENTATION
• AI operations for longterm templated document creation
» IND
» NDA
• Maintaining high quality standards with human reviews
• Available software applications harnessing AI capabilities
• Large database and archive searching with AI assistants
• Advances regarding external document linking potential
3:00 TIMELINE AND DATA REQUIREMENT FOR COMPLETE SUBMISSIONS ON A GLOBAL SCALE
As the focus of many notified bodies and pharmaceutical manufacturers continues to move towards a global perspective, it remains imperative that executives stay abreast of the nuances distinct to those regions that affect regulatory operations and submissions. This session series will provide in-depth looks at the regulatory requirements and associated deadlines to ensure proper and compliant submissions when including these areas in a global submission checklist.
Milan Shah, Head, Document Publishing Solutions, Regulatory Submission Management & Operations
JOHNSON AND JOHNSONS
3:45 CLOSING REMARKS AND END DAY TWO
Attendees by Job Title
%
Director
%
Manager
%
VP/Senior/Head
%
Other
Who Should Attend
Executives working within pharmaceutical & biotechnology corporations who will find this program of greatest relevance are those currently working to learn about viable automation solutions for workflow processes, as well as develop strategies surrounding global submission timelines and implementations of eCTD 4.0. Job titles for this meeting include:
Global Regulatory Affairs
Regulatory Affairs
Regulatory Operations
Submissions Management
Regulatory Publishing
Previous Attendees Include
Regulatory Affairs Operations Associate, ACCELERON LLC
Regulatory Operations Sr. Associate, AGIOS PHARMACEUTICALS
Director, Regulatory Operations, AGIOS PHARMACEUTICALS
Associate Director, Regulatory Operations, ALEXION PHARMA
Senior Director Regulatory Operations, ARCUS BIOSCIENCES
Associate Director, ASTRAZENECA
Regulatory Affairs Specialist, BAUSCH HEALTH
Director, Regulatory Operations, BIOMARIN PHARMACEUTICAL
AD Regulatory Affairs Submissions, BOEHRINGER INGELHEIM
Specialist II, Submission Services, BOEHRINGER INGELHEIM
Sr. Manager, Regulatory Affairs & Operations, BRII BIOSCIENCES
Regulatory Processes, Operations & Publishing, EAGLE PHARMA
Regulatory Operations Submission Management, EISAI PHARMA
Director of Regulatory Operations, FIBROGEN
Regulatory Operations Specialist, FLEXION THERAPEUTICS
Head, Regulatory Affairs, Project Mgmt, GALDERMA LABORATORIES
Senior Regulatory Operations Associate, GILEAD SCIENCES
Publishing Project Manager, IPSEN PHARMACEUTICALS
Sr Specialist, Regulatory Operations, KYOWA KIRIN PHARMA
Sr. Reg Ops Associate, LEADIANT BIOSCIENCES
Sr. Specialist, Regulatory Affairs, MERCK GROUP
Specialist, Regulatory Affairs, MERCK GROUP
Manager, Regulatory Operations, NANTKWEST
Global Head, Submission Management, NOVARTIS
Global Reg Affairs, Promotion Compliance, OTSUKA PHARMA
Head of Global Publishing, WW Regulatory Operations, PFIZER
Regulatory Publishing Specialist, PRA HEALTH SCIENCES
AD, Reg Information Management, PRA HEALTH SCIENCES
Senior Regulatory Affairs Specialist, SEATTLE GENETICS
Senior Regulatory Operations Specialist, UPSHER-SMITH LABS
AD, Regulatory Submission Management, VERTEX PHARMA
Director – Quality Systems, VYAIRE MEDICAL
