14th Annual

Pharmaceutical Regulatory Operations & Submissions Conference

October 29-30, 2025 | Boston, MA

Exploring Fundamentals of the eCTD 4.0 Transition While Evaluating the Impact of Automation Solutions on the Regulatory Operations Role & Mastering the Use of Regulatory Information Management & Publishing Tools

Program Overview

Engage in discussions with the FDA and learn how to fast-track your products to market with other industry executives and regulatory leaders at this pharmaceutical conference. Regulatory and submission publishing operations experts will share their experiences and knowledge on completing compliant regulatory dossiers to secure timely product approvals. You will also navigate the creation of submission dossiers and efficiencies in streamlining the dossier development process, including technology and AI integration, through resource management considerations.

Foster a sense of collaboration and safely connect with peers and expert presenters at this intimately-sized program. Customize your experience and address your unique concerns during dynamic Q&A after each session. Our commitment to industry perspectives keeps the program focused on what matters and dynamic session types allow you to stay engaged.

Countdown to the Pharmaceutical Regulatory Operations & Submissions Conference

Day(s)

Hour(s)

Minute(s)

Second(s)

Experience the Quality First Difference.

Learn from Industry Leaders

An exclusive experience with professional thought leaders provides you with direct insight into current solutions.

Keep up with Industry Trends

Learn through dynamic panel discussions, case studies and real world evidence on current topics directly related to your industry.

Exchange Ideas & Network

We provide a platform for your team to ask questions with experienced industry experts. The key to building your knowledge and seeing things from another perspective.

Find Solutions that Work for You

Insight and interaction are at the ready for you and your team. Collaborate with your peers, utilizing their insight and experience to accommodate your common challenges.

“Very useful to get your mind off of what only your company is doing and into other people’s experiences. This was my first Reg Ops/Subs conference and I want to attend the next one.”

**Megan Murphy, Senior Regulatory Operations Specialist, Flexion Therapeutics**

Reach out to us with any questions.

Our team will respond promptly!

Rob Britt
Senior Event Manager
Q1 Productions
+1 (312) 224-8773
rbritt@q1productions.com

www.q1productions.com

At Veranex, we can help you with concept through to commercialization by enabling:
• Accelerated speed to market
• Controlled development costs
• Development risk mitigation
• Market viability assessment

At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions.

Visit Sponsor Website

Since TrainingPros was founded in 1997, we have been dedicated to helping our clients find the right consultant for their projects. 25 years later, we are proud to have helped hundreds of clients complete their projects and thousands of consultants find great assignments. We continue to focus on helping our clients and consultants as well as our community as a certified women-owned, award-winning staffing company that works exclusively with Learning & Development professionals to match consultants to client projects.

Visit Sponsor Website

TELCOR is the proven leader of health care software solutions for revenue cycle management (RCM) software and services designed specifically for laboratories. TELCOR RCM, our SaaS solution, and TELCOR Revenue Cycle Services, our billing service, are designed to streamline workflow, improve collections, and provide real-time analytics. Our software and service solutions are designed for the unique challenges and requirements of laboratory specialties and the clients they serve. With full access to data, labs have complete visibility of their data and can track key performance indicators. No other vendor works as hard ensuring you get paid for the work you do.

Visit Sponsor Website

At Tipping Point Media, we pride ourselves on developing innovative, creative, and technically advanced virtual training and digital marketing solutions for the life sciences industry.

We push the limits of what's possible using Augmented and Virtual Reality to create revolutionary experiences proven to increase audience engagement and retention rates.

Our dedicated team of educators, medical experts, certified programmers, and digital renaissance innovators are committed to creating high-quality custom creations that bring your company's vision to life.

Visit Sponsor Website

VantagePoint Performance trains Salespeople to be more fluent and comfortable across different situations needing different sales approaches, and we train Sales Managers to be better coaches and team leaders, with more focus and less stress.

We’re different from the average sales training company because:

We don’t believe that one approach, one system, or one methodology is absolutely superior. All have something to offer, and the “best approach” or “best system” depends on the sales situation. This is what our applied, academic research tells us.
Our use of data science, specifically Machine Learning, helps us learn about our clients more meaningfully. We provide insights from each client’s data to help them understand what drives the success of their top-performing Salespeople and Sales Managers.
We are constantly feeding what we learn back into our training products, and we invest a bigger slice of our total energy into this innovation than the average sales training company. Our clients can access always-refreshed intellectual property and content through our training subscriptions.

Visit Sponsor Website

Policy Reporter, acquired by TrialCard in 2019, provides innovative healthcare software solutions to track payer policies in near real-time and enhances market access for the therapies patients need most. The company’s patented software-driven solutions include a suite of billing and reimbursement tools for providers and laboratories, market intelligence tools for payers, and a suite of market access solutions for life science companies. Its clients include some of the world’s largest pharmaceutical and healthcare companies.

Visit Sponsor Website

14th Annual

Pharmaceutical Regulatory Operations & Submissions Conference

October 29-30, 2025 | Boston, MA

Exploring Fundamentals of the eCTD 4.0 Transition While Evaluating the Impact of Automation Solutions on the Regulatory Operations Role & Mastering the Use of Regulatory Information Management & Publishing Tools

Program Overview

Countdown to the Pharmaceutical Regulatory Operations & Submissions Conference

Experience the Quality First Difference.

Learn from Industry Leaders

Keep up with Industry Trends

Exchange Ideas & Network

Find Solutions that Work for You

“Very useful to get your mind off of what only your company is doing and into other people’s experiences. This was my first Reg Ops/Subs conference and I want to attend the next one.”

Megan Murphy, Senior Regulatory Operations Specialist, Flexion Therapeutics

Reach out to us with any questions.

Our team will respond promptly!

Rob Britt Senior Event Manager Q1 Productions +1 (312) 224-8773 rbritt@q1productions.com

**Megan Murphy, Senior Regulatory Operations Specialist, Flexion Therapeutics**

Rob Britt
Senior Event Manager
Q1 Productions
+1 (312) 224-8773
rbritt@q1productions.com