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Presentations from EMEA
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At this folder are stored larger files, presenations and lists related to regulatory affairs procedures
Biosimilars: Guidelines and current experience
- Short Description:
- Dr Peter Richardson EMEA, Quality of Medicines Sector Biosimilars currently authorised - Centralised Procedure • Omnitrope (somatropi...
- Submitted By:
- zmauko
- Submitted On:
- 22 May 2008
- Downloads:
- 51
- Rating:
-
Total Votes:0
Clarification on traditional herbal products, and fast-track registration process
- Short Description:
- Contents: • Herbal medicinal product (legal definition) • Legal framework • Procedures (simplified registration) • Communi...
- Submitted By:
- zmauko
- Submitted On:
- 22 May 2008
- Downloads:
- 53
- Rating:
-
Total Votes:0
Classification issues and possible switch to OTC
- Short Description:
- Legal framework Directive 2001/83/EC (Community code relating to medicinal products for human use) • Article 71: Medicinal products shall b...
- Submitted By:
- zmauko
- Submitted On:
- 22 May 2008
- Downloads:
- 45
- Rating:
-
Total Votes:0
EudraVigilance and Risk Management within the EU Pharmacovigilance System
- Short Description:
- EudraVigilance and Risk Management within the EU Pharmacovigilance System
- Submitted By:
- zmauko
- Submitted On:
- 22 May 2008
- Downloads:
- 45
- Rating:
-
Total Votes:0
Incentives for orphan drugs, paediatric medicines and SMEs
- Short Description:
- Incentives for orphan drugs, paediatric medicines and SMEs Why do we need incentives/assistance to drug development? Facilitate access by p...
- Submitted By:
- zmauko
- Submitted On:
- 22 May 2008
- Downloads:
- 38
- Rating:
-
Total Votes:0
Outline of the EU pharmacovigilance system
- Short Description:
- • Pharmacovigilance activities come within the scope of the criteria of Q, S, E as new information is accumulated on the medicinal product...
- Submitted By:
- zmauko
- Submitted On:
- 22 May 2008
- Downloads:
- 57
- Rating:
-
Total Votes:0
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