Introduction to International Regulatory Affairs--Page
2
Issues for Modern Regulatory
Affairs
- Pharmacoeconomics
- Quality of Life
- Pharmacovigilance/Risk Management Planning
- Patents & Exclusivity
|
Regulation
of Development and Marketing of Prescription Pharmaceuticals
- Legal basis of international regulation of
pharmaceuticals
- Structure and function of Australia, New Zealand
and Canadian regulatory agencies
|
Clinical
Trial Applications/Procedures
- Australia, New Zealand and Canada - procedures & roles
of agency in CSA
- Pre-clinical, clinical, chemistry/manufacturing
requirements
|
Marketing
Authorization Applications – Australia, New
Zealand and Canada
- “Uncommon technical document”-
differences, regional requirements (with MAA
sections), alleged harmonizations
- Pharmaceutical environment
- Regulatory process
- Dossier, expert reports, outline of application
options
|
Issues
for Modern Regulatory Affairs
- Pharmacoeconomics
- Quality of Life
- Pharmacovigilance/Risk Management Planning
- Patents & Exclusivity
|
|
