Organisation & Legislation
Understand the system. Navigate the rules. Make informed decisions.
Days of Training
Core Modules
Compliance Focused
Regulatory Updates
About This Training
The healthcare landscape is complex, highly regulated, and constantly evolving. Professionals in the life sciences industry need to stay up-to-date on regulations, compliance, and healthcare system dynamics to operate effectively and ethically.
At Smelt Academy, our Organisation & Legislation trainings provide clarity on legal frameworks, healthcare system structures, and regulatory obligations, helping you make informed, practical decisions while staying compliant.
Duration
2–3 days of comprehensive, case-based training
Format
In-person workshops with case studies and optional online modules
Group Size
Optimal groups of 12–20 participants for interactive discussion
Outcomes
Certification and compliance reference materials
Example Training Modules
Each module is designed to build practical skills and drive behavioral change
Healthcare System & Relevant Legislation
Gain an overview of the Dutch healthcare system, financing, and the rules that safeguard quality and accessibility. Understand your responsibilities as a pharmaceutical or medical device professional.
Compliance & CGR in Practice
Learn what is permissible in promotional activities, congresses, and research sponsorship. Develop an ethical framework for decision-making based on real-life case studies.
GCP Update
Stay current with Good Clinical Practice standards. Refresh your knowledge, understand recent changes, and ensure your clinical research remains compliant.
Pharmacovigilance Basics
Master the fundamentals of monitoring and reporting adverse events, understanding safety obligations, and implementing pharmacovigilance procedures.
Drug Reimbursement & Regulatory Affairs
Explore the reimbursement landscape, payer structures, and regulatory requirements that affect market access and product launch strategy.
Ethical Decision-Making Framework
Apply legal and ethical principles to real-world scenarios. Develop confidence in making informed decisions within regulatory boundaries.
Who Should Attend?
Medical, Regulatory Affairs & Market Access Professionals
Needing to stay compliant and understand regulatory frameworks
Quality & Compliance Teams
Responsible for ensuring adherence to healthcare regulations and standards
Project Managers & Clinical Research Staff
Involved in compliance or clinical research implementation
Cross-functional Team Members
Seeking to strengthen knowledge of regulations and ethical decision-making
Learning Outcomes
- Clear understanding of Dutch healthcare system structure and financing
- Mastery of key regulations and compliance requirements
- Ability to apply pharmacovigilance and safety protocols
- Knowledge of clinical research standards and GCP
- Understanding of reimbursement and payer landscapes
- Confidence in making ethical, informed decisions
- Awareness of regulatory affairs and approval pathways
Training Approach
Learn
Master regulatory frameworks, healthcare systems, and compliance requirements
Discuss
Explore real-life case studies and ethical scenarios in group settings
Apply
Develop practical solutions and decision-making frameworks for your role
Ready to navigate the healthcare system with confidence?
Discover how our Organisation & Legislation trainings combine practical knowledge with a deep understanding of rules and regulations to help you operate effectively in a highly regulated environment.