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FDA & EMEA Patents Criteria in MA
 
FDA & EMEA Patents Criteria in Market
(20th & 21st April 2004)
 
Seminar themes: 
 
1.Originators’tactics to delay generic entry: 
Strategies took by innovators to protect their NCE with examples. Generic entry strategies are explained. 
2.FDA & EMEA policies and procedures on: 
A.Patent listing requirements for innovative manufacturers. 
B.Patent certification requirements for generic applicants. 
3.FDA & EMEA NCE and New Indication market exclusivity protections. 
4.Jordan FDA & MIT regarding patent protection and market exclusivity. 
 
Speakers
Dr. Heinz Goddar
Dr Andreas Winkler
Dr. Charles Raubicheck
Dr. Peter Bachmann
Dr. Mohammed Saleem. 
Mrs. Hala Khudary 
 
 
Originators tactics to delay generic entry: in this, theme we have to discuss strategies taken by multi nationals to protect their NCE. Examples such as omeprazole or any other will be explained. The examples have to show legal action taken and the out come. inevitably strategies will have to be reviewed and counter actions to such strategies are explained.
 
 
Official view: In this theme official from FDA, EMEA & Japan will be invited to give their view on the patent as a bar to generic entry in their respective authorities.
 
Competition law: pharmaceutical sector as the example area Regulations and implementation system is proposed regarding Jordan as the example to the area, due to Jordan implementation of TRIPS and the expected impact to countries like EGYPT & KSA.