Understand the importance of regulatory affairs and what happens within the regulatory departments and authorities - and why.

What Is The Course About?
This course provides a foundation level of understanding of the regulatory processes and requirements. If you work in a support role but need an understanding of regulatory affairs, then this course is ideal for you.

By the end of this course, you will understand:
- The role of the regulatory department in ensuring that trial drugs proceed to market safely.
- The regulatory procedures involved in clinical research.
- All of the requirements of the regulatory bodies who make the approval decision.
- The marketing and sales of new drugs on the market.
 
The full fee for this course is £590 +vat and includes full course materials, lunch and refreshments.

Course Programme:
Coffee & Registration
Welcome and Introduction
Regulation of the Pharmaceutical Industry:
- What is regulatory affairs?
- Differences in procedures and philosophies
- Quality, safety and efficacy
Drug Development & Clinical Trial Approval:
- The process
- The business and financial perspective
- Scientific activities
- Receptors
- Phases of trials in human subjects
- How are trials conducted?
- The Common Technical Document
12:30 - 13:30 Lunch
Controls of Trials in Human Subjects:
- Good science
- Ethics
- Regulatory
Regulatory Submissions:
- Content
- Procedures in the EU and USA
Marketing & Sales:
- Legal categories
- Marketing
- Sales
- Pharmaceutical Markets