The Evolution of Regulatory Dialogue in Digital Health: A Look Ahead
OPINION The upcoming DARWIN EU Advisory Board meeting scheduled for January 20, 2025, represents a pivotal moment for digital health regulation in Europe. With the digital health landscape evolving rapidly,…
The Impact of Virtual Meetings on Industry Collaboration
OPINION The upcoming 15th Industry Standing Group (ISG) meeting highlights a significant shift in how the pharmaceutical and medical device industries engage with regulatory bodies. The decision to hold this…
The Significance of the Seventh European Medicines Agency – EuropaBio Meeting
OPINION The upcoming Seventh European Medicines Agency – EuropaBio bilateral meeting represents a crucial junction in the intersection between regulatory frameworks and biotechnological innovation. As the landscape of drug development…
The Future of Clinical Trials: A Shift Towards Transparency and Accessibility
OPINION The upcoming walk-in clinic for the Clinical Trials Information System (CTIS) hosted by the European Medicines Agency represents a crucial step towards enhancing transparency in clinical trials. This initiative,…
The Evolution of Regulatory Dialogue in Pharma: A Reflection on the ISG Meeting
OPINION The upcoming 14th Industry Standing Group (ISG) meeting represents not just a gathering of industry players but a pivotal moment in the ongoing evolution of regulatory dialogue within the…
The Importance of Transparent Collaboration in Pharmaceuticals
OPINION The upcoming bilateral meeting between the European Medicines Agency (EMA) and Medicines for Europe is not just a routine event; it signifies a critical intersection of regulatory oversight and…
The Future of AI in Healthcare: A Critical Moment for Stakeholders
OPINION The upcoming HMA-EMA meeting focused on AI presents a pivotal opportunity for healthcare stakeholders to come together and deliberate on the integration of artificial intelligence in medicine. As we…
The Importance of Transparency in Regulatory Meetings
OPINION The upcoming meeting of the industry stakeholder platform at the European Medicines Agency brings to light a crucial aspect of the pharmaceutical landscape: transparency in regulatory processes. As stakeholders…
The Importance of Collaborative Approaches in Signal Detection
OPINION The upcoming EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection symbolizes a pivotal moment in the landscape of pharmacovigilance. As the complexities of drug safety monitoring continue to evolve,…
The Importance of Collaborative Workshops in Regulatory Frameworks
OPINION The upcoming workshop between notified bodies and expert panels is a crucial step in enhancing regulatory practices within the medical device sector. These collaborative engagements are essential for fostering…