Past Webinars

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Nov 19, 2025: Redefining Regulatory Collaboration Through Digital Transformation and Information Equity
Oct 28, 2025: Accelerating global drug approvals through digital trusted regulatory spaces
How can a secure cloud platform cut years off approval timelines and give every regulator and patient a front-row seat?
Apr 29, 2024: The impact of FHIR, Real-time Data Exchange, and IDMP on labelling and CMC
Jan 24, 2024: Acquisition, Mergers and Divestitures: How AI can Minimize Manual Efforts and Ensure a Smooth Transition
Oct 25, 2023: Implementation of Electronic Submission in China
Jan 24, 2023: EU CTR Lessons Learned and Future
Nov 08, 2022: Establishing an Industry Master Data Model for Traceability of Product Information
Jan 25, 2022: eTMF to RIM Integration Challenges
May 11, 2021: IDMP Vendor Showcase Day 2
May 06, 2021: IDMP Vendor Showcase Day 1
Apr 27, 2021: Validation of Robotic Process Automation (RPA)
Mar 09, 2021: Overview of Accumulus
Feb 09, 2021: Challenges with EU CTR 2022
Dec 08, 2020: UNICOM
Nov 10, 2020: Regulatory Revolutions and eCTD 4.0
Oct 13, 2020: Key Learnings: Gens & Associates 2020 World Class RIM Survey: Is Industry at a Performance Tipping Point?
Sep 18, 2020: FDA's PQ/CMC and KASA Initiatives
May 12, 2020: China eCTD Technical Standards and Submission Requirements Highlights
Mar 10, 2020: Transforming Device Identification: UNIQUE DEVICE IDENTIFICATION (UDI)
Jan 14, 2020: Navigating Acquisition and Integrations as a Regulatory Professional
Dec 10, 2019: Preparation of Conversion of CP/MRP/DCP Electronic Dossiers to UK Marketing Authorisations after Brexit
Nov 05, 2019: FDA Update on IDMP
Oct 08, 2019: Regulatory Operations Outsourcing: Navigating a Partnership to Maximize Value
Sep 10, 2019: Circular Information Management; representing a full medicine's lifecycle
Mar 21, 2019: IDMP Vendor Solutions Showcase - 2019 (Part 2)
Mar 20, 2019: It takes a Village: IRISS 10 Year History
Mar 19, 2019: IDMP Vendor Solutions Showcase - 2019 (Part 1)
Jan 08, 2019: Update on European substance management (EU-SRS) as part of SPOR
Dec 11, 2018: Data Quality & Integrity: The Impact of Data-Driven Initiatives within the Global Regulatory Environment
Nov 13, 2018: SEND and the New Nonclinical Data Requirements for NDAs and INDs
Oct 18, 2018: eCTD Version 4.0 Tools/Vendor Showcase
Sep 11, 2018: HL7 FHIR, Interoperability, and Electronic Regulatory Submissions
Jun 12, 2018: Update of the e-Roadmap within the EU
May 08, 2018: Prerequisites for Structured Content Management (SCM)
Apr 10, 2018: FDA eCTD v4.0 Update
Mar 13, 2018: Status Update on Health Canada's Structured Product Monograph (SPM) project
Feb 13, 2018: IMDRF ToC - What is it and how does it work?
Jan 09, 2018: The EU eAF and the integration with SPOR
Nov 20, 2017: Structured Content Authoring: Opportunities, Benefits and Challenges
Oct 11, 2017: Latest updates on the go-live for eCTD in South Africa
Sep 15, 2017: EU Clinical Data Transparency
Jun 15, 2017: The Future of CESP... CESSP
May 10, 2017: IRISS Special Project - Utilizing DOCX to Convey Structured Data in an eCTD
Apr 12, 2017: Health Authority Adoption of IDMP and Data Standards
Mar 08, 2017: Speed to IDMP Readiness - Automated Data Mining (SmPC's and more)
Feb 15, 2017: eCTD v4.0: Field-testing the Implementation Guides
Jan 11, 2017: FDA Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria
Nov 30, 2016: IDMP Vendor Showcase - Day 3
Nov 29, 2016: IDMP Vendor Showcase - Day 2
Nov 28, 2016: IDMP Vendor Showcase - Day 1
Nov 22, 2016: IDMP: Regulatory Harmonization/Variation in Implementation and its Impact on Industry
Oct 18, 2016: CTD: Revisions to the Granularity Document: Annex to M4
Sep 14, 2016: Benefits and Potential Challenges of Moving to the New FDA Module 1
Jul 13, 2016: Transitioning to eCTD for Advertising & Promotional Submissions with the Updated M1
Jun 08, 2016: Defining Substances and Organizing Regulatory Information: The deployment of the G-SRS at FDA.
May 11, 2016: Structured Content Management With DOCX
Apr 13, 2016: Submitting electronic DMF/ASMF dossiers (US / CA / EU / CH)
Mar 09, 2016: IDMP: A Compliance Project or a New Way of Conducting Business?
Feb 17, 2016: Submissions to the PSUR Repository via EMA Gateway/Web Client
Jan 13, 2016: IDMP - Use Case of a National Competent Authority, e.g. BfArM
Dec 09, 2015: Regulatory Information and Data Standards
Oct 14, 2015: A Quantitative Business Case for Structured Content
Sep 09, 2015: Knowing where we are going: Interoperability, eCTD, and Regulatory Information Standards
Aug 19, 2015: EDM Submission Reference Model - Shaping how submission content is managed

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