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Past Webinars

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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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