Introduction to Regulatory Affairs for Biotechnology
Course Objectives
This 2-day introductory course, the second in our Regulatory Affairs for Biotech curriculum, has been specifically designed for Regulatory Affairs professionals who are new to the Biotech industry. The training will provide a solid foundation on which to move forward in this ever-changing environment.
Gain a thorough overview of the Biotech industry - clarifying the latest requirements for regulatory compliance, how to achieve approval and how to predict the effects of changing technologies. Be confident in your dealings with global agencies with our interactive discussion groups and varied case studies.
What Will You Learn?
- Clarify and comply with regulatory requirements for biotech vs. synthetic-based drugs
- Meet validation requirements during the different stages of biotech drug development
- Identify the differences in EU and US submission regulations
Performance & Knowledge Objectives
- Examine the biotech industry and its impact on drug development
- Clarify the criteria for submitting biotech applications vs. synthetic-based products
- Build validation programmes to support different stages of development
- Compare EU and US drug submission procedures
Identify the latest regulatory requirements and compliance strategies available
Who Should Attend?
- Regulatory Affairs professional moving into the Biotechnology industry
- Those moving into Regulatory Affairs from other areas of the Biotech industry
- Regulatory Affairs, Registration and Documentation Assistants/Officers/Managers
Related Events
Reviews
"I enjoyed the course and I now have a good understanding"
Dates and Venues
21 Oct 2010 - 22 Oct 2010
Regus Trafalgar Square, London, UK
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
