European Medicines Agency closes PIM project

European Medicines Agency closes PIM project

The European Medicines Agency (EMA) announced the closure of the PIM project today.  The PIM, or the Product Information Management, project was established to increase the efficiency of the management and exchange of product information (summary of product characteristics, package leaflet and labelling) through the structuring of the information and its exchange by electronic means.

For More Information Please click EMA News 

Regards
Shakul.

EMA: Veterinary eSubmissions Readiness Map and Table

EMA: Veterinary eSubmissions Readiness Map and Table 

Please use the below web links to find the information

EU Readiness Map 

EU Readiness Table  

Regards

Shakul

 

 

 

EMA: New Web Page for Veterinary Products eSubmissions

EMA: New Web Page for Veterinary Products eSubmissions

For More Information Please use the below web link

EMA:Vet eSubmissions

Regards
Shakul.

EMA: New eCTD Validation Criteria (v3.1) and NeeS Validation criteria (v2.1) Effective from 1 September 2011

EMA: New eCTD Validation Criteria (v3.1) and NeeS Validation criteria (v2.1) Effective from 1 September 2011.

For More Information Please click the below web link

EMA:eSubmissions

Regards
Shakul.





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Exalon [eCTD}: Australian TGA revises NeeS guidance and seeks comments from stakeholders

Please find the information by clicking the below web

Exalon [eCTD Experts]

Regards
Shakul.

A Follow-the-Sun Approach to Publishing

A Follow-the-Sun Approach to Publishing

For More Information please use the below weblink

THE eCTD SUMMIT

 

TGA is seeking information or comments from industry for newly proposed regulatory requirements (Nee'S Submission) particularly from small sponsors.

TGA is seeking information or comments from industry for newly proposed regulatory requirements (Nee'S Submission) particularly from small sponsors. The consultation period is now open and will close on 1 May 2011.

For More Information please click the below web link

TGA

Regards
Shakul.

CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3

DIA course 'CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3'; April 04-06 Basel, Switzerland.


For More Information click below link

DIA

Regards
Shakul.

The Irish Medicines Board (IMB) has updated the national "Guide to electronic Submissions For Human Medicines"

For more information Please use the below weblink

IMB-eSubmission Link

Regards
Shakul.

Exalon [eCTD Experts]: EU eCTD and NeeS validation criteria updated by TIGes

Please find the information by clicking the below web

http://www.exalon.com/ectd-news/news-details/article/eu-ectd-and-nees-validation-criteria-updated-by-tiges.html

Regards
Shakul.