The regulatory landscape for medicines, medical devices, IVDs, clinical research, and digital health has evolved at an unprecedented pace throughout 2025. As we move into 2026, companies must prepare for new obligations, tightened enforcement, and transformative regulatory shifts across the European Union and key LATAM markets.
To help organizations navigate these changes, ClarkeModet invites you to an exclusive webinar reviewing the most relevant regulatory highlights of 2025 and the critical milestones expected for 2026 in EU and Latin America (Brazil, Colombia and Mexico).
Our international Regulatory Affairs experts will provide a structured, actionable overview of the changes that matter most for your strategic planning.
What to expect:
- Regulatory highlights and major developments for EC Mark registration and EMA regulatory approval
- Regulatory roadmap and registration pathways at ANVISA, INVIMA and COFEPRIS
- Recommended regulatory strategy to accelerate the launch of your medicine, medical device and cosmetic products in Latin America (Brazil, Colombia and Mexico)
- Key upcoming requirements, timelines and enforcement expectations for 2026
- Impact of EU level initiatives: MDR/IVDR, EUDAMED, EU HTA, AI Act, European Biotech Act and EHDS
- LATAM convergence trends, digitalized dossiers, reliance pathways and accelerated approval models
This webinar is designed to deliver practical, forward-looking insights, helping companies anticipate regulatory changes, manage risk, leverage AI-enabled tools, and define strategic priorities for the year ahead.Don’t miss the opportunity to stay ahead in a rapidly evolving regulatory landscape—register now to secure your spot!
Meet our experts:
Group Chief Regulatory Services Officer
ClarkeModet
Regulatory Services Director
ClarkeModet España