Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC

This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Informa
alt text

The introduction of substances, products, organizations and referentials (SPOR) requirements and the associated new target operating model (TOM) in Europe is forcing pharmaceutical companies to take a hard look at how and when they manage regulatory information. With the introduction of the new TOM, aligning existing regulatory data to the reference and master data in the Referentials Management Service (RMS), Organization Management Service (OMS), and Substance Management Service (SMS) will be key in delivering high quality Product Management Service (PMS) submissions in an efficient and timely manner.

Creating and maintaining alignment as your regulatory and SPOR data evolves will be no small challenge.

By watching this webinar, you will build a better understanding of:

    • The key factors and solution components to consider when building an “industry grade” regulatory data management capability

    • A data-driven approach to define data sources and assess the fit of existing data against the SPOR requirements
    • An operational model for profiling, aligning, and ensuring continued alignment of existing master and reference data with RMS and OMS
    • The key lessons learned from working with clients to align existing data to RMS and OMS

Utilize the experience gained and lessons learned by others to kickstart your journey towards the alignment of your regulatory data to SPOR, ensuring compliance with EMA’s new target operating model and increasing productivity along the way.

Speakers:

alt text

Jens-Olaf Vanggaard

Senior Director, Global Safety, Regulatory and Quality Solutions

IQVIA

Jens-Olaf Vanggaard is Senior Director, Global Safety, Regulatory and Quality Solutions with IQVIA. He is responsible for leading the Regulatory Solutions practice and has more than 15 years of experience providing advisory and project implementation services within Clinical Development and Regulatory Affairs. Jens-Olaf has strong domain expertise within Regulatory Information Management (RIM), IDMP, Data Governance and Master Data Management from a Regulatory Affairs and Pharmacovigilance perspective. Mr. Vanggaard received his M.Sc. in Business Administration and Computer Sciences from Copenhagen Business School.

alt text

Gary Wilson

Managing Director & Co-Founder of CorrIT

Creator of the SPORIFY web application

Gary holds a BSc (Hons) in Computer Science from Griffith College Dublin and has over 18 years industry and consultancy experience. Since the launch of SPORIFY in 2017, CorrIT have assisted many pharma organizations and regulators with their implementation and integration of SPOR Master Data Services and Controlled Vocabularies as they move towards their implementation of IDMP.

Hosted by

Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence

Complete the form to watch this webinar on demand!

By ticking this box, you agree to receive emails such as relevant news, updates and offers from Informa Business Intelligence, and carefully selected similar products from our portfolio

By completing this form you agree IQVIA may contact you directly about industry news, products, services and events that may be of interest to you subject to their privacy policy.