• Abschluss

    Certificate of attendance

  • Dauer

    1 Tag

  • Start

    17. Oktober 2026

  • Kosten

    free

  • Sprache

    Englisch

In an increasingly complex and highly regulated healthcare environment, understanding regulatory requirements is essential for ensuring product safety, quality, and timely market access. This course offers a clear and practical introduction to the regulatory landscape for medical devices, pharmaceuticals, and combination products. Participants gain insight into key frameworks, standards, and processes, enabling them to navigate evolving regulations and contribute effectively to compliant and responsible product development in a global context.
Salma Michor

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
Zum Anfang der Seite