Highlights & Features
What is happening at Regulatory Submissions, Information, and Document Management Forum
- Gather insights to hot topics impacting regulatory information in life sciences research and development
- Hear directly from global regulators on regulatory plans, priorities, and updates to incorporate into your everyday work and processes
- Identify how advanced technologies and innovation can be applied to impact functions and processes within regulatory affairs
- Network with like-minded professionals focused on regulatory information in life sciences research and development to discuss best practices and lessons learned
- Learn how to apply successful use cases, real-world examples, and practical outcomes into your own company or organization
- Gain insights and discuss how stakeholders are impacted by everyday challenges and how they overcomethese challenges
- Evaluate future applications of regulatory informatics, trial master file inspection readiness, electronic document management, and electronic regulatory submissions
Need Approval in Order to Attend?
Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Keynote Address!
February 12 | 1:25 - 2:00 PM Session 1: Keynote Address : Fostering Trustworthy and Responsible AI
Reggie Townsend, MBA, Vice President, Data Ethics SAS, With the increasingly widespread use of powerful data technologies, the importance of responsible innovation has never been greater. New and emerging technologies like AI have undeniably proven their potential in optimizing processes, improving decision-making, and enhancing the collection and management of data across the lifecycle. However, adoption may lead to several concerns such as transparency, unintended bias, and the need to stay compliant with new legal requirements. Reggie Townsend, VP of Data Ethics Practice at SAS, will share insights on how AI and other emerging technologies can be responsibly leveraged in regulatory affairs and operations. You’ll gain practical advice on how to join in on the responsible innovation movement and how your organization can maximize the rewards that you get from these technologies.
NEW Track Alignment for 2024!
Track 1: Building and Sustaining Successful RSIDM Foundations:
This focus area evaluates and provides insights on how to effectively build and sustain successful regulatory submission, information, and document management foundations within your company or organization. Gain knowledge on how to ensure compliance and stay up to date with the current state of affairs, enabling your business to continuously operate and thrive. The topics covered in this focus area are tailored to accommodate attendees who are either new to the field or seek a comprehensive review of the evolving dynamics and intricacies that shape their day-to-day work.
Track 2: Optimizing Processes and Procedures:
This focus area provides attendees the opportunity to explore what is needed to improve and optimize their organization or company’s processes and procedures to foster a culture of innovative practices and forward-thinking. Gain knowledge on industry best practices and discover techniques to transcend conventional approaches through problem-solving methodologies and investigation of the impact of new global regulations on your organization's processes and procedures. Tailored to meet the needs of intermediate-level professionals, the topics covered in this focus area provide a valuable platform for attendees seeking to elevate their expertise in the field.
Track 3: Adopting Innovative Technologies:
This cross-cutting focus area provides thought-provoking insights and new perspectives on how to effectively adopt innovative technologies into a company or organization and the systematic approach that is needed to assess the effectiveness and impact of the adopted innovations. Designed specifically for companies or organizations that have already undergone process optimization and transformation, this focus area equips attendees with the knowledge and expertise to propel their endeavors even further through the utilization of artificial intelligence, automation, and cutting-edge technologies. Gain first-hand knowledge from global regulatory health authorities on the implementation of new technologies, policies, and guidelines. Geared towards professionals operating at the intermediate to advanced levels of their careers, this focus area nurtures and expands your acumen to achieve pioneering achievements in your field.
Track 4: Achieving Regulatory Excellence:
Developing the ability to achieve regulatory excellence in the life sciences industry necessitates a unique blend of visionary leadership, a culture that embraces transformative change and innovation, strategic decision-making integrated into the company's fabric, an unwavering commitment to continual improvement, and bold actions that challenge conventional norms. This focus area will take a deep dive exploring examples and use cases from companies and organizations that have achieved this successfully while also delving into a wide range of professional and business-related topics. Engage in invigorating panel discussions, absorb invaluable best practices, and acquire tangible and practical implementation strategies to steer your company or organization towards regulatory excellence. This area of focus has been tailored specifically for individuals at an advanced or senior level position within their careers.
Hosted Sessions!
DIA is hosting two excellent Case studt at this event. at this same venue during the same week!
Regulatory Content and Submission Primer: Content from Authoring to Archive - Part 1 of 2
Friday, February 9 10:00AM-2:00PM ET – Primer: PART 1 - VIRTUAL
Monday, February 12 8:00AM-12:00PM – Primer: PART 2 – IN-PERSON, Bethesda North Marriott Hotel & Conference Center
This Primer is designed to demystify electronic Common Technical Document (eCTD) submissions and meet the needs of individuals who are either new to biopharmaceutical-based regulatory submissions in electronic format, or for those individuals who are experienced in one area and are looking to gain a broader understanding. This Primer will present the full spectrum of electronic regulatory submissions from document authoring through submission and archiving. Please visit our Hightlights and Features page to discover more about wthat this Primer will cover.
Short Course: Driving IDMP Readiness and Compliance: Impact, Business Benefits, Strategies, and Application of AI
February 06, 2024 – 9:00AM ET – 1:00PM ET | In-person
*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*
This half-day virtual. The Short Course starts with a general update on the global IDMP implementation, including a deep-dive into the new European pharmaceutical legislation with an impact assessment from Industry on the practical implications.
Receive $150 off your forum registration by registering for any combination of at least two short courses and/or primers as well as the main forum. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.
Short Course: Driving IDMP Readiness and Compliance: Impact, Business Benefits, Strategies, and Application of AI
February 08, 2024 – 10:00AM ET – 2:00PM ET | In-person
*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*
This half-day virtual. As our data exchange moves toward full digitization, HL7 Fast Healthcare Interoperability Resources (FHIR) is emerging as the standard by which the Life Sciences industry will communicate data electronically.
Receive $150 off your forum registration by registering for any combination of at least two short courses and/or primers as well as the main forum. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.
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