Medical Writing Institute Spring 2015 Regulatory Documentation Part 1.

Welcome to Part 1 of the Medical Writing Institute Spring 2015 Regulatory Documentation Certificate!

This is a course in 4 parts in which we are going on a journey, starting with a walk by Lake Mbezi which may, or may not, be on the continent of Africa. We are going through processes needed to turn a pretty plant with amazing antibiotic powers, into an antibiotic which will be sold by registered pharmacists to sick folks who have been given a prescription for it by a licensed healthcare professional.

To be awarded a certificate, you will need to show competency in understanding antibiotics: what they are, what they do, and all the ways humans can become resistant. You will also need to show competency in understanding the documents that are needed to take a plant from a tropical jungle to laboratory testing to giving to humans to making sure humans remain safe.

Theoretically, you could be ready for your exam in 4 weeks. If you have experience preparing documents for regulatory agencies, and have strong health and science backgrounds, you could be ready for your exam immediately. Your exam will be 2 parts: written documents and oral exam, which will be recorded and you can keep.

Please listen to the show, and get started on your journey with the tropical plant you found near Lake Mbezi.

Enjoy! If you don't like it, you can enroll in the Pharmaceutical Management Certificate, which is for medical writers who do not like regulatory writing. And for anyone looking for a career in the international pharmaceutical industry.