Regulatory Affairs Mastery

• You work in regulatory affairs and don’t want to miss out on the latest developments in Artificial Intelligence (AI) in this area.
• You work in the medical technology or pharmaceutical industry and would like to learn more about topics like “Green Hospital” and sustainability.
• You work in development, manufacturing, quality management or regulatory affairs and would like to improve your skills in
  • communication and medical/technical writing in regulatory affairs.
  • the principles of clinical trial design and understanding and evaluating statistics in medicine.
  • the challenges of ethics that are faced by regulatory affairs professionals.
  • regulation of the marketing of medicinal products and medical devices.

Ideally you have a degree in medicine, pharmacy, chemistry or life science, engineering, law, materials science, business studies or a related field, along with a fundamental understanding of regulatory affairs in the medical technology or pharmaceutical industry.

Communication / Medical writing in Regulatory Affairs

• Developing a communication strategy
• Effective communication techniques
• Communication with internal and external stakeholders
• Medical and technical writing for regulatory affairs professionals
• Technical writing: Medical devices
• Medical writing: Pharmaceuticals

Understanding and evaluating statistical statements in medicine

• Clinical study design
• Statistical methodologies

Regulation requirements in the marketing of pharmaceuticals and medical devices

Application of artificial intelligence (AI) in everyday working life of a regulatory affairs professional

• Challenges of using AI in the healthcare industry
• AI for regulatory affairs 

Ethics and sustainability in the development, product and disposal of pharmaceuticals and medical devices
 

Semester project (Living Case)

Levels of competence

1. Knowledge of terms, definitions, and regulations; factual knowledge.
2. Understanding the context, ability to explain complex matters.
3. Applying knowledge in simple situations.
4. Analysing one’s own solution method.
5. Synthesis of new solutions and application in complex situations.
6. Assessing applicability for specific problems and situations, evaluating of methods and of alternatives, connections with other fields of expertise.

A module may include a variety of teaching methods such as lectures, seminars, case studies, practical labs, assignments, etc.

For the 12 ECTS credits to be recognized, successful completion of the competency assessment is required (exams, semester work).

Ideally you have a medical, pharmacy or science degree, an engineering education, legal studies, a higher education in material science, a degree in Business Administration or in a related field.