-
Graduation
Certificate of attendance
-
Learning format
-
Duration
1 day
-
Start
17 October 2026
-
Costs
free
-
Language
English
In today’s highly regulated healthcare environment, understanding regulatory requirements is essential for ensuring patient safety, product quality, and successful market access.
Dr. Salma Michor, MBA
C- Level Pharma and MedTech, entrepreneur, non – executive and executive board member, strategist
Target Group
- Professionals in biomedical engineering, regulatory affairs, pharmaceutical sciences, or related life sciences fields seeking foundational or advanced knowledge of regulatory and quality standards
- Employees in the biotech, medtech or pharma industries involved in product development, quality assurance, clinical affairs, or compliance, needing to understand legal and regulatory requirements
- Early-career professionals preparing for roles that require interaction with authorities, notified bodies, or oversight of conformity assessment and market release processes
Overview of Course Contents, Schedule
- Session 1: Introduction to current laws, guidelines, regulations, and standards. Definitions. Medical device and medicinal product development; Clinical evaluation and clinical studies; risk assessment and risk management
- Session 2: Post-market surveillance and vigilance; product liability; data management, recording and integrity, EU versus U.S.
- Session 3: Case study & group work - regulations
Schedule
| Session | Date | Time |
|---|---|---|
| Session 1 | Oct 17, 2026 | 09:00-10:30 |
|
Session 2 |
Oct 17, 2026 | 11:00-12:30 |
| Session 3 | Oct 17, 2026 | 13:30-16:30 |
Date
Oct 17, 2026
(Registration deadline: Sept 20, 2026)
Do you have any questions?
I am happy to advise you.