Modul 2: The Power of Variations: Making Regulatory Affairs Work Across Functions

Der Anmeldezeitraum für dieses Seminar ist beendet.

“Why do Regulatory Affairs make everything so complicated and slow?”

This seminar is designed for professionals involved in regulatory affairs, project & quality management, or manufacturing who seek better understanding on the complexity and strategic importance of managing variations in medicinal product marketing authorisations.

Despite often being perceived as administrative or routine tasks, variations are a critical part of the product lifecycle and can significantly impact timelines, costs, and compliance. This module will demystify the regulatory framework, explain why careful planning pays off, and highlight the value of cross-functional collaboration with Regulatory Affairs.

Agenda & Content Overview:

• Basics and classification of variations
• Grouping and worksharing
• Strategic planning and internal coordination
• Common problems and how to avoid them
• Case studies and interactive discussion

Target group:

This module is aimed at professionals involved in regulatory affairs, project & quality management, or manufacturing who seek better understanding on the complexity and strategic importance of managing variations in medicinal product marketing authorisations

Time

10.00 - 14.00 o'clock

This seminar is part of the compact course “Smart Regulatory”. If you complete all three modules, you will receive the certificate “Regulatory Affairs in Practice – Drug Approval & Lifecycle Management.” Alternatively, modules can also be attended by different people from the same company – in this case, however, no certificate will be issued.

This module will be held in English, but questions can also be addressed in German.

Price per person and excluding VAT. DREHM Communication and Innovation will provide catering for the participants of this seminar day.

Photo & Video Recordings

Photos and videos will be taken during the event. By participating, you agree that this material may be published on our website and social media channels for advertising and informational purposes. If you do not agree to this, please contact us in advance of the event.