Click here to open a printer-friendly view of the page

Click here to return to the TOPRA home page
 
Regulatory Rapporteur
 
i118.jpg December 2006 Vol. 3, No. 12  - Focus Article
In this issue:
• New EU Regulation on paediatric medicines
• Quality Systems approach to GMP for medical devices
• Salaries in Regulatory Affairs

November 2006 Vol. 3, No. 11  - Focus Article i116.jpg
In this issue:
• TOPRA Symposium reports
• Aginus Kalis interviewed
• Preparing for electronic submission

i114.jpg October 2006 Vol. 3, No. 10  - Focus Article
In this issue:
• Effects of drug pricing policies
• Key competences for regulatory affairs professionals
• Devices: moving to ISO 13485: 2003

September 2006 Vol. 3, No. 9  - Focus Article i104.jpg
In this issue:
• Legislation on medicinal gases
• Review of the Prescription Drug User Fee Act
• Named patient supply
• Continuing Personal Development

i100.jpg July / August 2006 Vol. 3, No.7/8  - Focus Article
In this issue:
• Focus on complementary/alternative medicines
• Inaugural meeting of TOPRA North America
• Regulation of ophthalmic products

June 2006 Vol. 3, No. 6  - Focus Article i93.jpg
In this issue:
• Multilingual product information
• Avian influenza
• EU Devices directives update
• Open eCTD forum

i90.jpg May 2006 Vol. 3, No. 5  - Focus Article
In this issue:
• European risk management strategy
• Incentives for SMEs
• 10 years of EMEA CNS submissions - a rapidly acting sleep inducing agent
• Consistency of Scientific Advice

April 2006 Vol 3, No. 4  - Focus Article i87.jpg
In this issue:
• Future regulation of Advanced Therapy Products
• Interview with Dr pekka Kurki
• User testing of PILs
• Regulatory Intelligence Update

i86.jpg March 2006 Vol 3, No. 3  - Focus Article
In this issue:
• Advanced Therapy Medicinal Products
• Homeopathic Medicines
• Increase your word power - biotechnology definitions
• Re-use of single devices
• 10 years of EMEA CNS medicines - a new dual action antidepressant

February 2006 Vol 3, No. 2  - Focus Article i83.jpg
In this issue:
• The role of immunoassays and bioassays
• Impact of new pharamaceutical legislation
• Pre-clinical challenges facing cell-based medicinal products

i78.jpg January 2006 Vol 3, NO. 1  - Focus Article
In this issue:
• Focus on immunotoxicity guidelines
• Assessing carcinogenicity in the absence of standard rodent carcinogenicity data
• The value of regulatory information in clinical research
• 10 years of EMEA CNS medicines - Anti-dementia treatments

Regulatory Rapporteur - Previous Years

 
 Home  Help  Contact us  Site map  Members logon