Regulatory Submissions, Information, and Document Management Forum (RSIDMF) – February 12-14, 2024
Celegence invites you to join us for the Regulatory Submissions, Information, and Document Management Forum (RSIDM) from February 12-14, 2024, in North Bethesda, Maryland, USA. Meet our team of experts at Booth 106 to speak directly about how our full spectrum pharmaceutical services and software solutions can help you navigate the most complex challenges that pharmaceutical regulations pose.
Don’t miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management! Join your industry colleagues and regulatory thought leaders by registering for the RSIDM Forum 2024.
- When: 12th February 2024 8:00 AM – 14th February 2024 2:05 PM
- Where: Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852, USA
- How To Register: Register Here
- Why: This Forum provides multiple opportunities to network with like-minded professionals focused on regulatory information in life sciences research and development to discuss best practices and lessons learned.
About DIA’s RSIDMF 2024
At DIA’s Regulatory Submissions, Information, and Document Management Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related systems.
The Forum presents four tracks:
- Track 1: Building and Sustaining Successful RSIDM Foundations
- Track 2: Optimizing Processes and Procedures
- Track 3: Adopting Innovative Technologies
- Track 4: Achieving Regulatory Excellence
The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.
Celegence’s Presentations
Celegence is excited to be an exhibitor during this year’s RSIDMF in North Bethesda, MD. We will have the following presentations:
- Complying with EU CTR, Managing Business Change and Submissions in CTIS
14 Feb 24 8:30 AM – 14 Feb 24 9:45 AM
Speaker: Hans van Bruggen, Chief Scientific Officer
In this session, panelists will discuss sponsor approaches to comply with EU CTR, the importance of managing business process changes, and the challenges they dealt with along the way. We will explain the mandatory use of EMA’s Clinical Trial Information System (CTIS), the redaction requirements, and the impact to sponsor business processes. We will also share anonymized screenshots of CTIS, how sponsors have used automation technologies to streamline CTIS data entry, address the dynamics between MSCs (Member State Countries), their Health Authorities and Ethics Committees. Register for the session here.
- So, You Think Technology Solutions are Failing your Content Transformation? Did You Set Them up for Success?
14 Feb 24 8:30 AM – 14 Feb 24 9:45 AM
Speaker: Matthias Sijtstra, Senior Regulatory Data Specialist
Many companies are investing heavily in software to digitize and automate their regulatory content operations with varying success. The most successful intelligent automation implementation teams think content before software: a software-agnostic mindset is key to success. Building, adopting, and sustaining software-agnostic content standards help organizations put the needs of people and processes before technology selection. Our goal is to demonstrate how applying a software-agnostic content standards methodology can break the ground and pave the way for effective content transformation across people, processes, technology, and data/content. Register for the session here.
About Celegence – Pharmaceutical Solutions and Services for Life Sciences Industry
Celegence provides the pharmaceutical industry with consulting services and technology solutions that are tailored to the evolving operational and strategic needs of manufacturers in areas such as RIMS data management, publishing and medical writing. We can assist you throughout the entire product life cycle to ensure that you and your organization are compliant with all global pharmaceutical regulatory requirements.
Download the latest brochure of our full suite of compliance services for the Pharmaceutical Industry here.
Complimentary Consultations
Visit us at Booth 106 for complimentary consultations with Celegence’s experts throughout the event. You can view the firsthand demo of our technology solutions – Dossplorer™ and Dosscriber™ that are tailored to the needs of pharmaceutical organizations.
To learn more, reach out to info@celegence.com or contact us online or simply stop by the booth in the exhibitor area to meet with us. We hope to see you there!
