Regulatory Affairs for Biotech
Course Objectives
The process of drug development is changing rapidly as biotech techniques are becoming more mainstream, and more and more biotech based drugs are coming to market. Regulation of biotech products is fundamentally different from that of NCEs.
Are you fully aware of the extent of these differences and are you confident you have the knowledge you need to work in this field?
This course addresses the issues of real and perceived risks associated with biotech products, and the way the regulatory agencies are dealing with this based on the trainers’ own experiences. This course assumes some knowledge of the science behind biotech.
What Will You Learn?
- A 2-day Training Course tackling read more
- Learn how to register your biotech product successfull read more
- Know whether data generated is adequate for your dossier submission read more
- Clarify the manufacturing process for biotech products read more
- Gain a complete view of developing a biotech product read more
- Clarify the regulatory requirements when submitting your dossier read more
- Identify the risks associated with biotech products at each stage of the process read more
- Successfully compile manufacturing data into the CTD format read more
Why you should attend
The ‘Regultory Affairs for Biotech" course tacks real and perceived risks associated with biotech products, and the consequent interpretations of biotech regulations from a case study-centred approach. Demonstrating the critical steps to compliance. Leran if data generated is adequate for your dossier submission and this course will clarifying the manufacturing process for biotech products.
Who Should Attend? Professionals of.......
- Regulatory Affairs
- Registration
- Compliance
- QA/QC
- Manufacturing/Production
- Product Validation
- Process Validation
Reviews
"The trainers and handouts were excellent"
Related Events
CMC Analytical, Comparability and Stability Studies for ...
14 Oct 2010 - 15 Oct 2010
Regus Trafalgar Square, London, UK
Dates and Venues
08 Mar 2010 - 09 Mar 2010
Regus St James's Park, London, UK
18 Nov 2010 - 19 Nov 2010
Regus Poultry, 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
