IIR PTI

Mon 08 Mar 2010 - Tue 09 Mar 2010 To Be Confirmed, London, United Kingdom Thu 18 Nov 2010 - Fri 19 Nov 2010 To Be Confirmed, London, United Kingdom

This unique course covers all that the non- specialist needs to know about molecular and cell biology, the science behind biotechnology. Regulatory affairs professionals need to have a greater role at an earlier stage in drug development of biotech products and, therefore, need to be able to speak the same language as their product and process development colleagues. This will reduce the risk of there being gaps in the data submitted at registration, reducing time to market. The course will highlight where these techniques affect the regulatory affairs and quality control sectors.

Who Will Attend? This course is highly recommended for anyone working in pharmaceutical, biotechnology or biologics companies who do not have a scientific background in biotechnology and molecular biology, and are working in the following departments: • Regulatory affairs • Registration • Compliance • QA/QC • Manufacturing/Production • Product Validation • Process Validation

"Very focused course" Regulatory Affairs Manager, Kendle International Global Regulatory Affairs, A Nelson & Co Ltd

Course Leader

Joanna Tufnell Founder and Chief Executive Officer PharmaRegistration International (PRI) Ltd Joanna has the rare distinction of senior level experience in the pharmaceutical industry, the Veterinary Medicines Directorate (VMD) and as a Principal Pharmaceutical Assessor with the Medicines Control Agency (MCA). This expertise provides the PRI Group with a unique insight into the successful development and registration of all pharmaceutical products. Joanna’s particular areas of expertise include biological / biotechnology and high-technology products, coupled with a highly regarded ability to develop successful strategies for product development.