Regulations and Innovations

This Teaching Unit is organized into two teaching blocks, namely the regulatory environment of health products and the world of intellectual property.

Block 1 covers the basic regulatory package for various types of healthcare products:

• Regulatory requirements for chemicals (REACH regulations).

• Regulatory requirements for cosmetics.

• Regulatory requirements for drugs (originator, generic, biosimilar, “me too”).

• Regulatory requirements for drugs incorporating a medical device.

• Regulatory requirements for radiopharmaceuticals.

• Regulatory requirements for medical devices.

• Recent and future regulatory developments (e.g. advanced therapy drugs, CMR chemicals). Block 2 presents the world of intellectual property and, more specifically, industrial property:

• Intellectual property (IP) and its various forms.

• Patents in the healthcare field and freedom-to-operate studies.

• Patent search strategies.

• Data protection in connection with drug registration files.

• Falsified and counterfeit drugs.