Hybrid Event
20-22 May, 2025Steigenberger Wiltcher's, BrusselsHybrid Event
20-22 May, 2025,
Steigenberger Wiltcher's, Brussels
20-22 May, 2025,
Steigenberger Wiltcher's, Brussels
Wednesday 21 May 2025
Deepen Your Understanding into Regulatory Developments and take Practical Legal Guidance from EU Commission, EMA and leading Pharmaceutical Stakeholders
Master the Intricacies of Regulatory Policy
Real World Consequences of Regulatory Policy
- Update on progress of the EU Pharmaceutical Legislation revision
- New EU legal instruments to address shortages of critical medicines
- Scope of hospital exemptions under the new pharmaceutical package
Case Study Analysis of Recent Court Cases
- Learnings from the D&A Pharma and Pharma Mar cases
- Repercussions of the Traslarna and the Ocaliva cases
- How will the Sanofi Nexviadyme case impact new active substance designation
Latest Advances in Regulatory Frameworks
- Early experiences of EU HTAR and implementing regulations
- Review of frameworks for early access and compassionate use
- Proposed revisions to EU MDR and IVDR and key update on SoHo
