Filing Variations Conference 2014
March 20 - 21, 2014
Berlin , Germany
What Will You Learn?
Clarify the January 2010 Variations revisions including the latest amendments
Formulate Variations procedures that achieve faster approval Manage the practical hurdles of submitting your Variations on time and with the right supporting data
Understand the impact of the CTD on your Variation dossier
Collect and present complete information on your Variations
Streamline your Variation procedures for international applications
Tackle the challenges of type II Variations under the MRP
Who Should Attend?
This course will be beneficial to Regulatory Affairs personnel who take part in filing:
Regulatory Affairs
Dossier registration department
Product Information
RA compliance
Personnel from other disciplines who have an impact on the process of filing Variations, such as manufacturing, development, clinical safety, pharmacovigilance
Clarify the January 2010 Variations revisions including the latest amendments
Formulate Variations procedures that achieve faster approval Manage the practical hurdles of submitting your Variations on time and with the right supporting data
Understand the impact of the CTD on your Variation dossier
Collect and present complete information on your Variations
Streamline your Variation procedures for international applications
Tackle the challenges of type II Variations under the MRP
Who Should Attend?
This course will be beneficial to Regulatory Affairs personnel who take part in filing:
Regulatory Affairs
Dossier registration department
Product Information
RA compliance
Personnel from other disciplines who have an impact on the process of filing Variations, such as manufacturing, development, clinical safety, pharmacovigilance
Related events
Filing Variations Conference March 20 - 21, 2014
