Regulatory Affairs and Intellectual Property Rights

• Regulatory inspections, guidance and technologies
• GMP, CMC

Regulatory affairs are also known as government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals like plant protection products and fertilizers, energy, banking, telecom, etc. Regulatory affairs have a very specific impact within the healthcare industry.

Regulatory affair professionals usually have a responsibility for the following general areas:

• Ensuring that their companies obey all of the regulations and laws pertaining to their business
• Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business
• Advising their companies on the regulatory aspects and climate that would affect proposed activities

Intellectual property rights are the legal rights that provide inventors protection for original works, inventions, or the appearance of products, artistic works, scientific developments, and so on. There are four types of intellectual property rights. They are:

• Patents
• Trademarks
• Copyrights
• Trade secrets