Advanced Course  Navigating Regulatory Variations: From Change to Approval

NVFG

Postillion Hotel Bunnik

Strengthen your expertise in EU regulatory variations with this advanced, practice-driven course led by experienced regulatory professionals.Our advanced course, "Navigating Regulatory Variations: From Change to Approval” offers an in-depth exploration of the EU Variation Guideline, with strong focus on CMC and safety-related changes. The programme combines regulatory background and guideline interpretation with real-world examples and hands-on case studies.This course is organised by RegNed, a division of NVFG. Why attend?Advance your regulatory skills through a one-day, practical course that bridges variations and successful approvals. This course is structured into four focused parts, guiding you from the regulatory foundation and recent guideline updates to real-world documentation requirements, safety assessments and CMC troubleshooting. Case-based learning is embedded to reinforce understanding and application. What will be covered?- Regulatory foundation:An overview of the regulatory history of the EU Variation Guideline, general principles for post- approval changes and a guided walkthrough of the latest Guideline updates, including hands-on regulatory experiences.- In-depth focus on key variation types:o Safety variations: understanding the link between variations and pharmacovigilance including how outcomes relate to the Pharmacovigilance Risk Assessment Committee (PRAC).o CMC variations: Assessing the impact of changes to Module 3 aspects, complemented by a practical case study, reflecting submission challenges and regulators’ feedback.- Practical regulatory strategies:Clear guidance on grouping and work-sharing procedures, how to select the correct pathway and what documentation authorities expect in different scenarios. Who Should Attend?This course is intended for Regulatory Affairs professionals, and all others involved in the preparation and submission of EU Variations who wishes to deepen their practical and strategic understanding. Course Practicalities· Date: Tuesday 2 June 2026| 9:00h to 17:00h· Location: Postillion Hotel Bunnik, Bunnik· Format: One-day course with presentations and interactive sessions. Lunch is included· Language: Presentations and course materials will be in English· Materials: Bring your laptop. Course materials will be provided (where possible). Registration· Maximum of 30 participants: register now!· Fee: € 300,- (excl. BTW) for NVFG members, € 450,- (excl. BTW) for non-members· Note: the fee to become a member of NVFG is €135,- in the first year and €185,- annually thereafter We look forward to seeing you there! NVFG and RegNedNVFG is the abbreviation for “Nederlandse Vereniging voor Farmaceutische Geneeskunde” (Dutch association for Pharmaceutical Medicine) and supports its members to perform their roles in this particular working field. RegNed, a division of NVGF, is a network of professionals in Regulatory Affairs and platform for knowledge sharing focused on daily practice and future perspectives of Regulatory Affairs. Contact details NVFGLeidsestraatweg 41D 3443 BP Woerden085 004 30 84 info@nvfg.nl

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Advanced Course Navigating Regulatory Variations: From Change to Approval

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Advanced Course Navigating Regulatory Variations: From Change to Approval

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