Regulatory Affairs Mastery

• You are interested in a career in regulatory affairs in the pharmaceutical, life sciences or medical device industry.
• You work in development, manufacturing, quality management or regulatory affairs and would like to improve your skills in
  • communication and medical writing in regulatory affairs.
  • the principles of clinical design and understanding and evaluating statistical claims in medicine.
  • the use of AI in the day-to-day work of a regulatory affairs professional.
  • regulation of the marketing of medicinal products and medical devices.
  • sustainability and ethics in the life cycle of medicines and medical devices.

Ideally you have a degree in medicine, pharmacy or science, engineering education, law, materials science, business studies or a related field and a basic education in regulatory affairs.

Communication / Medical writing in Regulatory Affairs

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

Understanding and evaluating statistical statements in medicine

• Principals of clinical design / phases of clinical studies
• Statistical Methodologies
• Application of artificial intelligence (AI) in the healthcare industry
• Challenges of using AI in the healthcare industry
• AI for regulatory affairs professionals
• AI for regulatory affairs (examples from industry and government)
• Regulation requirement in the marketing of pharmaceuticals and medical devices:
• Delivery, consulting and presales roles

Regulation requirement in digital marketing of pharmaceuticals and medical devices

• Sustainability & ethics in the development, production and disposal of medicinal products and medical devices
• Sustainability and ethics in the lifecycle management of pharmaceuticals
• Sustainability and ethics in the lifecycle management of medical devices
   

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.