The objective of this course is to impart knowledge and practical understanding about the Drug, biotech and medical devices Regulatory Affairs and approval process in US.
Course Title: KPE’s Certificate Program in USFDA regulation of pharmaceuticals, biotech and medical devices regulation
Features of the Course:
1. Orientation to practical understanding USFDA Regulatory process of pharmaceuticals, medical devices and biotech products.
2. Simulation to real life Strategic planning in US market
3. Access to industry case studies.
4. Attend Live Lectures of all different chapters / study content.
Duration: 1 Month
Course Description
This online course utilizes interactive learning tools to guide each participant through to understand of the USFDA regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work the steps of approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
The course can be completed at any pace, allowing the user to stop and start at their leisure.
Who should attend?
- Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
- Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
- Anyone wishing to update their knowledge on European regulatory affairs
- Regulatory Affairs, Registration and Documentation assistants/officers/managers
