is being presented by Anabel Pérez, Senior Project Manager, with ForeignExchange Translations and airs on Wednesday, May 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
Showing posts with label EMA. Show all posts
Showing posts with label EMA. Show all posts
Tuesday, May 1, 2012
Wednesday, February 1, 2012
Meeting the Linguistic Requirements for EMA Submissions
is being presented by Anabel Pérez, Senior Project Manager, with ForeignExchange Translations and airs on Tuesday, February 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
Monday, October 3, 2011
Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)
is being presented by Dr. Andrew Marr, Managing Director, of Marr Consultancy Limited and airs on Tuesday, Novemeber 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com
The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.
EMA has issued a detailed guidance and technical specification for providing this information – both data and product information (labeling) documents. These requirements pose a major challenge for industry to provide quality data on time. This audio conference presentation reviews the information EMA needs – and why – and discusses business process and technical options available to Marketing Authorization Holders, to support provision of data as required to EMA.
The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.
EMA has issued a detailed guidance and technical specification for providing this information – both data and product information (labeling) documents. These requirements pose a major challenge for industry to provide quality data on time. This audio conference presentation reviews the information EMA needs – and why – and discusses business process and technical options available to Marketing Authorization Holders, to support provision of data as required to EMA.
Friday, February 5, 2010
EU Centralized Procedure for Generics
Since its inception in 1995, the centralized procedure has been used for new and biological drugs. Now that the data protection period for the first approvals at EMA is over, generics can be approved in the European Economic Area using the centralized procedure. But does this make sense? What are the alternatives? What is the decision matrix to be used to decide upon the “right procedure”?
This presentation gives answers to these and several more questions on the EMA, the CP and its role in generics approval.
EU Centralized Procedure for Generics is being presented by Dr. Ulrich Granzer, Principal Consultant, Granzer Regulatory Consulting and airs on Tuesday, March 9, 2010. For more details or to register, please visit our site at www.fxconferences.com
This presentation gives answers to these and several more questions on the EMA, the CP and its role in generics approval.
EU Centralized Procedure for Generics is being presented by Dr. Ulrich Granzer, Principal Consultant, Granzer Regulatory Consulting and airs on Tuesday, March 9, 2010. For more details or to register, please visit our site at www.fxconferences.com
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