Implementation of XEVMPD has been challenging for everyone involved due to short timeframes, deadlines and changes in the technical requirements. ISO IDMP legislation which will come into effect in mid-2016 brings about a global scope and the requirement for data integration across the companies. Comprised of five ISO standards, the purpose of IDMP legislation is to standardize the identification of medicinal products and thus improve pharmacovigilance across products, companies and jurisdictions. ISO IDMP is much more of a challenge than XEVMPD.
This live webcast will not only bring you up to date with currently available IDMP implementation guidance, but shall also evaluate the impact by interpreting it and defining essential initial activities. What parts of guideline are straightforward and doable, which areas are complex yet feasible, and where are further guidance needed? How to leverage controlled vocabularies? Where do roles and responsibilities lie?
Join the leading industry experts to:
- Understand the IDMP legislation
- Figure out data at hand and how to draw together data you do not have
- Draw and maintain information about packaged medicinal products to prepare for IDMP compliance
- Work towards a single, authoritative data repository
Hans van Bruggen,
Senior Regulatory Affairs Scientist
Hans van Bruggen is Director of Qdossier. He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. He has gained a wealth of experience and a comprehensive view on what is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. Hans has built up a solid reputation as a consultant for the pharmaceutical industry and is a popular and respected speaker at many regulatory congresses.
Michiel Stam,
Regulatory Operations Consultant
Michiel Stam is a subject matter expert in the field of Regulatory Operations. He has worked on various submission and information management projects for Pharma and Biotech companies over the past 7 years. He has a strong focus on XEVMPD, IDMP and Regulatory Information Management. Current and most recent projects include; implementation of a global RIM solution, which allows for XEVMPD submission management (including migration development, data cleaning and consolidation, project management and controlled vocabulary management); developing a strategy for XEVMPD bulk update and ongoing maintenance through EVWEB, with a focus on data collection and strategy; coordinating XEVMPD bulk update for clients using Qdossier's hosted XEVMPD solution.
Siniša Belina,
Senior Life Sciences Consultant
Mr. Belina started his professional career in Pliva (now member of the TEVA Group). In addition to his responsibilities in manufacturing, he was part of the successful EDMS implementation project. He later joined KRKA’s Regulatory Affairs department and finally moved to INFOTEHNA. He applies his detailed knowledge of pharmaceutical documentation and processes to areas of business process analysis and optimization of EDMS.
- Comprehend upcoming ISO IDMP standards, understand impact and define essential activities to prepare
- Figure out data at hand and how to draw together data you do not have
- Draw and maintain information about packaged medicinal products to prepare for IDMP compliance
- Define roles and responsibilities to work towards a single, authoritative data repository
- HQ and Affiliate Regulatory Affairs
- HQ and Affiliate Pharmacovigilance
- HQ and Affiliate IT
- HQ and Affiliate Quality Assurance
- Management
- Regulatory Information Management
- Data Managers
- Global Submission Managers/Project Managers
- Regulatory Affairs and Operations
- Information Technology and Support Personnel
- Document and eRecords Managers
- Regulatory Standards Implementation Specialists and Associates
- Quality Assurance and Compliance Professionals
