www.mitrogroup.com

My specialities are medical writing (clinical study reports, IND submissions, clinical expert reports) and inclusion of medical devices on the Australian Register of Therapeutic Goods (ARTG).  Recent experience includes pharmacovigilance, medical information, and clinical trial regulatory and ethics activities throughout the Asia Pacific region.  A registered and practicing pharmacist I currently work part-time in retail pharmacy and at the Royal Children's Hospital as a Clinical Trial Pharmacist, chairing the Adverse Drug Reaction Committee and reviewing clinical trial protocols for the Drug Trial Subcommittee.

This includes:

• Clinical Study Reports and Clinical Expert Reports for medicines and devices
• Protocols and Investigator's Brochures
• Investigational New Drug applications
• Ethics Committee applications
• Clinical Trial Notification / Clinical Trial Exemption submissions
• Consumer Product Information and Product Information

We also have experience with the following:

• Project Management - regulatory and development activities e.g. manufacturing
• Regulatory - marketing approval applications
• Medical Information
• Pharmacovigilance - safety reporting
• Systems Development and Implementation e.g. quality/document management 
• Business Process Improvement - procedures to improve performance