Synchronisation for Success - Manage Affiliate feedback and impact on harmonised submission content
Challenge: How to manage regulatory processes - centrally or in affiliate offices? Should there be a regulatory team in every country/region? CTD and eCTD were supposed to standardize and harmonize the submission content, but what is the role of affiliate offices in submission preparation process? Even with the above standardisation, managing dossiers by headquarters and affiliates remains an issue as the access to consistent regulatory data and content is still a concern. Can this risk be mitigated with a next generation RIM solution that enables headquarters to collaborate with affiliates on submission content, data and status?
Some of the issues:
1) Unifying the regulatory processes between headquarters and affiliates by enabling compliant collaboration.
2) Reducing the overall regulatory complexity by utilizing an integral system despite the increasing complexity due to expanding regulatory requirements and submission formats.
3) Planning of activities and resources on global product program level while tracking them on a local country specific level.
4) Maintaining one collaborative repository/database for all data/content but providing local context relevant data to the affiliates.
Description of the webinar content:
• Overview of the typical challenges in the collaboration between headquarters and affiliates
• Next generation RIM solution and (master) data model options
• Integral approach of submission management and RIM
• Setting up roles, permissions, lifecycles, automations to leverage all RIM Apps
• Actionable reports and their role in maintaining compliance
Presented by
Sinisa Belina,
Senior Life Sciences Consultant
Sinisa started his professional career at Pliva (now member of the TEVA Group), where in addition to his responsibilities in manufacturing, he also engaged in successful EDMS implementation project. Belina 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.
