11th Annual

Global Regulatory Affairs CMC Conference

October 8-9, 2025 | Boston, MA

Securing Timely and Positive CMC Regulatory Approvals through a Comprehensive Understanding of ICH Standard Expectations and Decoding the Global Regulatory Landscape

Program Overview

Dive deep into supporting products as they evolve throughout the product’s lifecycle and navigate guideline changes and global regulatory harmonization challenges. Sessions and group discussions provide CMC teams insight to ensure a product’s chemical makeup, quality and efficacy are showcased through strong evidentiary support. You will be better equipped to streamline approval processes and deliver uninterrupted product supply chains.

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.

“This was a very impressive meeting. The topics of discussion were very relevant, speakers AND audience were very engaged. It was a great arena to share best practices. All were willing participants.”

John Alvino, Associate Director, Global Regulatory Affairs – Chemistry, Manufacturing, and Controls, MedImmune

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.

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

AMPLEXOR Life Sciences is a global provider of regulatory, quality and safety software solutions, serving and trusted by pharmaceutical, biotechnology and medical device companies for over 25 years. Its holistic Life Sciences Suite solution helps life sciences organizations to be efficient with launching products and breaking into new markets quickly while ensuring quality, efficacy and safety through end-to-end support to product lifecycle processes, data and content management. Life Sciences Suite is powered by the Compliance Foundation platform, which enables unified management of data, content and processes in a familiar user interface combined with powerful automation engine that drives complex process automations, migrations and integrations suitable for both cloud and on-premises deployment models.

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At Veranex, we can help you with concept through to commercialization by enabling:
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At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions.

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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.

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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.

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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.

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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.

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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.

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11th Annual

Global Regulatory Affairs CMC Conference

October 8-9, 2025 | Boston, MA

Securing Timely and Positive CMC Regulatory Approvals through a Comprehensive Understanding of ICH Standard Expectations and Decoding the Global Regulatory Landscape

Program Overview

“This was a very impressive meeting. The topics of discussion were very relevant, speakers AND audience were very engaged. It was a great arena to share best practices. All were willing participants.”

John Alvino, Associate Director, Global Regulatory Affairs – Chemistry, Manufacturing, and Controls, MedImmune

Experience the Quality First Difference.

Learn from Industry Leaders

Keep up with Industry Trends

Exchange Ideas & Network

Find Solutions that Work for You

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

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