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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
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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
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| Vol. 3, No. 9 - Focus Article |
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In this issue:
Legislation on medicinal gases
Review of the Prescription Drug User Fee Act
Named patient supply
Continuing Personal Development
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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
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| Vol. 3, No. 6 - Focus Article |
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In this issue:
Multilingual product information
Avian influenza
EU Devices directives update
Open eCTD forum
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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
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| Vol 3, No. 4 - Focus Article |
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In this issue:
Future regulation of Advanced Therapy Products
Interview with Dr pekka Kurki
User testing of PILs
Regulatory Intelligence Update
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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
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| Vol 3, No. 2 - Focus Article |
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In this issue:
The role of immunoassays and bioassays
Impact of new pharamaceutical legislation
Pre-clinical challenges facing cell-based medicinal products
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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
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Regulatory Rapporteur - Previous Years
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