Asphanews June 2017

Asphanews June 2017

Igenomix receives EMA Orphan Drug Designation for its product indicated for Asherman’s Syndrome with Asphalion support
Igenomix, a company leader in reproductive genetics and experts in infertility problems announced that its product autologous adult bone marrow-derived non-expanded CD133+ haematopoietic stem cells (IGX1) was granted the Orphan Drug Designation (ODD) on March 15th 2017 by the European Medicines Agency (EMA). More info
The EMA received in 2016 the highest number of initial applications for biosimilars
Asphalion has large experience in Biosimilars and is glad to highlight this positive trend in EU. More info 
 
Don’t miss our free webinar about New Medical Devices Regulations!
Get ready for the upcoming changes! Don’t miss our free webinar to assist you about their implementation. 
 
Free webinar on Data extraction from SmPCs into structured data for ISO IDMP compliance
On 7th July at 10.00 a.m. (CET), Asphalion together with OntoPharma is hosting a demo about the automatic data extraction from the SmPCs. More info 
 
Complimentary Webinar: Mandatory Use of eCTD in Europe
Register now for EXTEDO’s and ASPHALION’s Complimentary free Webinar “Mandatory Use of eCTD in Europe” on 22 June 2017. More info 
Meet us at:
5-6/07      FORUM Science&Health, Munich, DE
2?4/10     TOPRA Annual Symposium, London, UK
24-26/10  CPhI Worldwide, Frankfurt, DE – Stand 91B30
24-26/10  Global Pharma Regulatory Affairs Summit, Prague, CZ 
 
 
SPOR, IDMP & ROG updates from the meeting with EMA
The EMA received in 2016 the highest number of initial applications for biosimilars

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