6th Annual

Medical & Regulatory Writing for Product Approvals Conference

April 26-27, 2023 | Arlington, VA | Westin Washington DC – City Center

Navigating Evolving Regulatory Expectations, Writing Team Retention Challenges, and the Increased Utilization of Automation Tools to Ensure Timely Product Approvals

Program Overview

The competitive pharmaceutical space calls for increased demand in getting new submissions quickly approved by regulatory agencies to ensure an expedited time to market for new products, placing enhanced pressures on the efficiency and quality of regulatory writing and submissions teams. As major international regulatory bodies continue to evolve and make great strides to standardize the format and content necessary for all approval dossiers, pharmaceutical organizations continue to explore how to best streamline writing operations for global, timely and complex submissions.

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 Medical & Regulatory Writing for Product Approvals Conference

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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.

“The topics Q1 Productions provided were very informative and useful. I gained more insight into the medical policy process and benefited from sharing challenges and best practices with other colleagues in the industry. The conference was very organized and provided a forum that encouraged collaboration. I definitely plan on attending again.”

Distinguished Presenters Include:

Dorothy Saewert
Senior Director, Medical Writing
DAIICHI SANKYO, INC

David Sorscher
Director, Oncology Medical Writing
MERCK

Monica Eiland
Associate Director, Medical Writing
TAKEDA

View Full Agenda

“It was a fun to be part of a well-organized event and in the company of knowledgeable industry professionals, thanks again!”

The Q1 Productions Event Experience

Are You a Solution Provider?

Reach out to us here.

Our Sponsors

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

We are on the edge. The leading edge, that is. We solve written communications challenges faced by the life sciences industry today.

The Criterion Edge Advantage
• Deep expertise in medical communications across an expansive range of diseases and emerging therapeutic areas
• Advanced-degree medical and scientific writers and librarians that produce accurate, quality deliverables
• Experience serving the pharmaceutical, biotech, medical device, and in vitro diagnostics markets since 2
• U.S. headquarters with global operations that accelerate projects 24/7
• U.S. based executive team with over 60 years of medical, scientific, and regulatory experience
• Unsurpassed project management that provides full-service support
• Flexibility and scalability to support global start-ups, mid-size and large life sciences companies
• Customizable solutions and budgets for every project timeline adherence

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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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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.

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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.

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.

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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.

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.

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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.

Visit Sponsor Website

6th Annual

Medical & Regulatory Writing for Product Approvals Conference

April 26-27, 2023 | Arlington, VA | Westin Washington DC – City Center

Navigating Evolving Regulatory Expectations, Writing Team Retention Challenges, and the Increased Utilization of Automation Tools to Ensure Timely Product Approvals

Program Overview

Countdown to the Medical & Regulatory Writing for Product Approvals Conference

Experience the Quality First Difference.

Learn from Industry Leaders

Keep up with Industry Trends

Exchange Ideas & Network

Find Solutions that Work for You

Distinguished Presenters Include:

Dorothy Saewert Senior Director, Medical Writing DAIICHI SANKYO, INC

David Sorscher Director, Oncology Medical Writing MERCK

Monica Eiland Associate Director, Medical Writing TAKEDA

“It was a fun to be part of a well-organized event and in the company of knowledgeable industry professionals, thanks again!”

The Q1 Productions Event Experience

Are You a Solution Provider?

Reach out to us here.

Our Sponsors

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

Dorothy Saewert
Senior Director, Medical Writing
DAIICHI SANKYO, INC

David Sorscher
Director, Oncology Medical Writing
MERCK

Monica Eiland
Associate Director, Medical Writing
TAKEDA

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