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Dossier requirements
Dossier requirements – including new Global Quality initiatives 
(29th - 30th April 2008 – Amman/ Jordan). 
Seminar themes:
1. CTD-structure (EU-Module 1) Paediatric Registration in EU. 
2. CTD – Module 3 (Pharmaceutical Development, ICH Q8 & ICH Q9) Quality by design. 
3. ICH Q10 Quality Management (Batch release in real time). 
4. Legal requirements for Generic applications. 
5. Strategies for market penetration in Saudi Arabia & GCC: demystifying product choice & patents.  
6. Quality of active substance and drug product: (Impurities, Heavy metals & Genotox impurities). 
7. Reaching a Market authorization in the EU via MRP/DCP and Maintenance of the MA – incl. overview of the new draft proposal for a new Variation Regulation. 
8. Drugs patent data: Jordan & Egypt 
Dr. Laila Jarrar
Dr. Saleh Bawazir
Dr. Christa Wirthumer-Hoche
Dr. Fritz Erni
Dr. Mohammed Saleem 
Dr. Rana Azzam. 
Focus on Pharmaceutical CTD modules 1 & 3
This seminar will focus on module 1 and module 3 of the ICH CTD. However in order to do so the seminar will start by explaining the different routes of reaching market authorization in the EU and maintenance of such market authorization. Module 1 will be discussed and concluded by suggesting common administrative requirements for our area. Module 3 will follow with special emphasis on impurities. Finally the seminar will allude to the recent EU paediatric regulations including expected patent and data exclusivity rights in light of such changes followed by the patent scenes in selected Arab countries.
Reaching a Marketing Authorization in Europe via MRP/DCP 
Generic applications - legal requirements (more or less the same presentation like we had it in Muscat) 
Maintenance of a Marketing Authorization - overview on the Variation system in Europe (current version and new draft proposal from the EU-Commission) 
Paediatric Regulation 
CTD - Module 1 - administrative data for the EU
CTD - Module 3 - general principles, focusing on the Quality documentation 
Pharmaceutical Development. Risk Management ICH Q8 & ICH Q9 ICH Q10 Quality Management - Batch release in real time 
Quality of active substance 
o Impurities 
o Heavy metals 
o Genotox impurities
Drugs patent data illustrated in
o Jordan,
o Saudi Arabia,
o Egypt