Regulatory Submissions, Information, and Document Management Forum (RSIDMF) – February 13-15, 2023

Celegence invites you to join us for the Regulatory Submissions, Information, and Document Management Forum (RSIDMF) from February 13-15, 2023, in Bethesda, Maryland. Meet our experienced team at booth #102 to speak directly about how our full spectrum pharmaceutical services help you navigate through the most complex challenges that pharmaceutical regulations can pose.

Don’t miss the latest conversations in Regulatory Informatics, EDM and TMF, and ERS! Join your industry colleagues and regulatory thought leaders by registering for the RSIDM Forum!

• When:February 13-15, 2023
  • February 13, 2023, 7:30 AM – 5:30 PM EST
  • February 14, 2023, 7:30 AM – 5:30 PM EST
  • February 15, 2023, 7:30 AM – 5:30 PM EST
• 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 for networking, knowledge sharing, and education for both business and technology-focused attendees.

At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) 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: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by FDA and other regulatory authorities are offered each day.

Celegence is excited to be an exhibitor during this year’s RSIDMF in Bethesda, MD. We will have the following presentations, short courses, and other contributions:

1. Short Course: On the Road to an EU Filing: Getting Familiar with Critical EMA IT Systems

Instructor: Matthias Sijtstra, Senior Data Management Specialist, Qdossier, a Celegence company, Netherlands

This is a Virtual Pre-Conference Short Course in conjunction with the Regulatory Submissions, Information, and Document Management Forum.

This Short Course will be offered virtually – join from anywhere! During this short course the instructors will introduce you to the systems that applicants will have to interact with, and which are critical on your road to an EU filing. This will include an overview of the various EU portals, EMA IT systems, data management initiatives and electronic procedures (e.g., IRIS, CTIS, DADI). You can register here.

*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

2. Welcoming Remarks and Presentation of the Excellence in Service Award

Feb 13, 2023, 1:00 PM – Feb 13, 2023, 1:25 PM | Ballroom E-H
Speaker: Michiel Stam, Director Regulatory Information Management, Qdossier – A Celegence Company, Netherlands

You can register here.

3. Session 7 Track 1: New Developments in RIM Reference Model and IDMP Semantics

Feb 14, 2023, 2:00 PM – Feb 14, 2023, 3:15 PM | Ballroom FGH
Speaker: Hans van Bruggen, MSc, Chief Scientific Officer, Qdossier – A Celegence Company, Netherlands

In this session, the team will present a simpler (object-centric) version of the model. The primary objective of the latest update is to make the model easy to understand, adopt and implement by sponsors, vendors, and system integrators alike. You can register here.

4. Session 8 Track 1: IDMP Ontology: Semantic Interoperability Throughout the Entire Medicinal Product Lifecycle

Feb 14, 2023, 4:15 PM – Feb 14, 2023, 5:30 PM | Ballroom FGH
Session Chair: Michiel Stam, Director Regulatory Information Management, Qdossier – A Celegence Company, Netherlands

This session will introduce the IDMP Ontology initiative of Bayer, Boehringer Ingelheim, GSK, J&J, Merck KGaA, Novartis and Roche, coming together at Pistoia Alliance Pistoia Alliance’s IDMP Ontology project. It will provide an outline of the implementation challenges of ISO IDMP standards at pharma companies and showcase how an ontology can help achieve semantic interoperability of product data. You can register here.

5. Session 10 Track 2: Along the Path of Drug Approval; A Hodgepodge of Correspondence With the FDA, EMA Support for SMEs and ICH M11 CeSHarP | EMA’s Approach to Support Innovations Coming from Small- and Medium Sized Enterprises

Feb 15, 2023 10:30 AM – Feb 15, 2023 11:45 AM | White Flint (Lower Level)

Session Chair: Michiel Stam, Director Regulatory Information Management, Qdossier – A Celegence Company, Netherlands
Speaker: Matthias Sijtstra, Senior Data Management Specialist, Qdossier, a Celegence company, Netherlands

During this session, presenters will cover a variety of different topics. This session will explore the insights gained through a study of various kinds of FDA correspondence, the benefits of getting EMA’s SME support, and an overview of the ICH M11 Clinical electronic Structured Harmonized Protocol (CeSHarP) initiative. These seemingly unrelated topics share one common goal; efficient, consistent, and reliable exchange of information sponsors and regulators to promote innovation and development of new medicines. You can register here.

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.

Visit us at Booth #102 for complimentary consultations with Celegence’s experts throughout the event.

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!