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DIA Global 2022

DIA Global 2022
Justin Savesky | Executive Director, Regulatory Tech Services
Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire documentation lifecycle, and meeting your organization’s goals on expediting your release to market. With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients.
Synchrogenix™ Writer
Trevor Standish | Director Product Management
Certara’s Synchrogenix™ Writer is designed specifically to assist your medical writers in creating patient safety narratives through an easy-to-use interface that streamlines writing deliverables through automation, reusability, and advanced technology. Unlike traditional methods of manually writing patient narratives, the cloud-hosted and validated regulatory software ensures consistency and quality, as well as decreased production times and costs.
Pinnacle 21™
Philip Johnston | Director Product Management
Pinnacle 21 Enterprise 5.1.0 offers immense value to experts in biostatistics and biometrics, and clinical and statistical programming. Pinnacle 21 Enterprise validates data quality and compliance with Clinical Data Interchange Standards Consortium (CDISC) standards, enabling a clean data pipeline from worldwide sponsors to health authorities. Pinnacle 21 Enterprise customers include 22 of the top 25 biopharmaceutical companies by R&D spend, as well as the US FDA and Japan’s Pharmaceutical and Medical Devices Agency.
Optimizing Patient Narrative Technology: Automating the Complicated and Creating Efficiency
Reema SelvaRaju | Safety Project Manager, Regulatory and Access
Exhibit Hall Theater #1 Narratives are a key component of clinical study reporting. To present a concise & medically relevant patient story, writers must analyze large volumes of data for patients. Implementing technology will ensure quality, consistency, and decreased turn-around times. We will discuss the automated approach to work through complex sources to produce streamlined narratives for submission. Greater efficiencies will empower writers to focus on critical thinking, a quality which remains unique to humans. Register here:
Monika Nowak | Associate Director, Global Enterprise Accounts
Developing interactive and easy-to-use stakeholder engagement content for market access, medical affairs, and sales field teams is a time-consuming, expensive, and often decentralized process. BaseCase is a “no-code” platform that enables you to visualize large complex datasets and economic models, clearly demonstrating the value of your products to key decision-makers.
Special Session - Reception and Presentation! Project Optimus: How to engage with the FDA to advance your program
Demetrius Carter, SVP, Services Operations, Regulatory Services | Julie Bullock, PharmD Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine |
Given the launch of Project Optimus, how do you best navigate the evolving regulatory landscape and determine the optimal way to engage with the agency? Join this special event at DIA 2022 to address key questions that will help you to create a plan that’s tailored to your needs, whether you are at pre-IND stage or already in the clinical phases. Location: Prairie Room located on the 2nd floor of the Hyatt Conference Center Register here:
Writing at Lightspeed: Optimizing Submission Dossiers in Today’s Environment Through Better Processes, Planning, and Technology
Chair: Angela Russell Winnier, PhD Speaker Optimizing Efficiency and Quality in Regulatory Documents Through Better Writing Processes Julia Forjanic-Klapproth, PhD Managing Increasingly Divergent Global Submission Requirements Steve Sibley, MS Shifting the Paradigm: A Structured Content Authoring Journey Angela Russell Winnier, PhD |
This is a hybrid delivery (in person and virtual). Recognize how using efficient writing processes will save time and improve the quality of the documents generated; Identify key considerations for planning simultaneous multi-region marketing applications; Describe the potential for a structured content authoring software platform to enhance preparation of summary documents. Register here: