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Protocol Generation Request

  

    Please be informed that a study protocol is requested for:
 

     Generic Drug Name:
   

      Test Product

 
   

      Test Product’s Name:
   
      Test Product’s Dosage Form:
   
      Test Product’s Strength:
   
      Sponsor’s/Test Product’s Manufacturer  

(Name)     

   

         (Address)     

   
      Sponsors Signatory Representative:  
Name
   
Title
   


IPRC News

 
     Reference Product    
     
     Reference Product’s Name:  
     
     Reference Product’s Dosage Form:  
     
     Reference Product’s Strength:  
     

     Reference Product’s  Manufacturer

    

                                                                               (Name)     

 
     

             (Address)     

 
     
     Study’s condition:  
     
     Study design:  
     

     Intended Regulatory submission
  Jordan   GCC
       
  USA

  EU
       
  Other    
 
     
     Number of volunteers to be involved  
 
Drug Analysis Methodology

 
     
     

 
 
       Comments:

 
 
Final Report shall be issued in accordance with the requirements mentioned under European Agency for the Evaluation of Medicinal Products (EMEA), Note for Guidance on the Structure And Content Of Clinical Study Report (CPMP/ICH/137/95). July 1996.
 

Requested by

Date
 

 
 
 
 

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