Content + Structure
Portrait
The healthcare industry evolved greatly over the last 10 years. As a result, the tasks of Regulatory Affairs Professionals have changed accordingly. New technologies such as artificial intelligence and machine learning (e.g., decision support systems), home virus detection kits, wearable patient monitoring devices, companion diagnostics and precision medicine are already being used today. In the wake of such innovations and the resulting revision or creation of new regulations, Regulatory Affairs Professionals must continually expand their knowledge.
To obtain and maintain regulatory approval of healthcare products, Regulatory Affairs Professionals must fulfill the following core tasks:
- Developing regulatory strategies
- Implementing regulatory measures
- Adhering to quality management
- Solving trade-related issues
- Negotiating/communicating with authorities
- Crisis management
Objectives
With the imparting of the above-mentioned expertise and the knowledge of the ever-changing regulations, the MAS Regulatory Affairs lays the foundation for entering the healthcare industry as a Regulatory Affairs Professional:
Developing regulatory strategies
- Global regulatory strategies, e.g., ICH (International Harmonisation)
- Structure and function of the relevant regulatory authorities
Implementing regulatory measures
- EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR)
- Marketing authorisation, including the preparation of the scientific and technical dossier
- Clinical evaluation
- GxP
- Market surveillance (pharmacovigilance/materiovigilance)
- Knowledge of IT and data sciences
- Product classes subject to special regulation (e.g. combination products or blood plasma)
- Software as a Medical Device (SaMD)
Adhering to quality management
- Quality management system according to ISO 13485 and ISO 9001
- Pharmaceutical Quality System according to ICH Q10
- Interfaces to processes such as risk management, usability engineering, reviews, design verification, design validation and process validation
Solving trade related issues
- (Digital) supply chain management of medical and pharmaceutical products
- Most important methods of traceability
- Falsified products
- Marketing and digital marketing
Negotiating/communication with authorities
- Interaction with regulatory authorities, e.g. how meetings between applicant and regulatory authority are conducted
Crisis management
- Leadership and management skills
Statement
Christina Degen-Wendlinger
Senior Consultant, inmedis GmbH
“I am impressed how the students of the CAS Regulatory Affairs in Life Sciences combine the knowledge acquired in the seminars with practice in their case studies, resulting in well-founded new implementation solutions. In my opinion, this is what makes the MAS Regulatory Affairs stand out. The students are specifically prepared for the challenges of their working world.”
