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Generic pharmaceutical drug registration & IP

Generic pharmaceutical drug registration & IP

(7th – 9th January 2008 – Muscat/ Oman). 
Seminar themes: 
1. Recent law changes in favor of generic pharmaceutical business aspects. 
2. Possible ventures with German manufacturers. 
3. Implementation of an efficient Pharmacovigilance System. 
4. Technology status and future trends regarding eCTD
5. Technology status and future trends regarding eDMS. 
6. eCTD national experience. 
7. The generic in-house approach. 
8. The licensing approach
Dr. Yvonne Proppert
Dr. Elmar Korth
Mr. Andreas Suchanek
Mr. Andreas Treptow
Dr. Christa Wirthumer-Hoche
Dr. Andreas Winkler
Dr. Heinz Goddar
Dr. Mohammed Saleem.
This two-day conference will run in four sessions. Each session is dedicated to one subject. 
The first session is focused on possible business ventures between local companies and those from German counter parts. In this regard, the managing director of the German association for pharmaceutical manufacturers (BAH) Dr. Bernd Eberwein will address the participants on recent changes in the German Law from pharmaceutical manufacturing in favor of expanding business opportunities. It will be followed by the president of (FAH) presentation Dr. Yvonne Proppert on business possibilities currently open with local German companies. 
The second session will focus on current requirements and experiences for a generic dossier management and eCTD submission which is a harmonize procedure to be implemented as of next year in major European markets. 
The third session will extend to the rationale of a German GMP inspection and Current legal requirements for generic submissions including important Court cases in Europe regarding generics. 
The fourth will focus on the integration of intellectual property rights that interact with the process of drug registration of generic products mainly in GCC countries.
Following the conference for one day there will be three parallel training workgroups:
- IP work group: Training on the patent status analysis in order to arrive at freedom to operate opinion regarding generic submission. Starting from KSA patent example the claims are read and analyzed to steer R&D away from infringement.
- eCTD/eDMS workgroup: Training in compiling actual generic dossier management and  eCTD submission.
- GMP workgroup: Training on tips for a successful inspection by a German inspectorate.