Jasmina Savic

Inhaberin, Founder and Managing Director at Phortas GmbH, Phortas GmbH
Aachen, Germany

Fähigkeiten und Kenntnisse

Global Regulatory Strategy
Authority meetings and preparation
Pediatric drug development
Orphan drug development and designations
Due diligence activities
Regulatory Intelligence
EU and USA Marketing Authorization procedures
eCTD compilations
IND preparations
EU-wide Clinical Trial Application preparation/sub
Post-marketing life-cycle activities (variations
Labeling activities (CCDS updates SmPCs/PILs etc
Writing/critical review of submission relevant doc
Responses to authorities
Scientific Advice Briefing Books
Pediatric Plans
Clinical Study Protocols
Investigator Brochures
Clinical Trial Reports
CCDS/SmPC/USPI
CTD Module 2 clinical documents
Orphan drug designation documents
Expert statements
Regulatory Affairs
Clinical Management
Development Consulting
Regulatory Affairs Consulting

Werdegang

Berufserfahrung von Jasmina Savic

  • Current 8 years and 9 months, since Sep 2017

    Founder and Managing Director at Phortas GmbH

    Phortas GmbH

  • Current 12 years and 2 months, since Apr 2014

    Regulatory Affairs Consultant

    JS Regulatory

  • 3 years, Apr 2011 - Mar 2014

    Manager, Global Regulatory Affairs (Development)

    Grünenthal GmbH

  • 1 year and 3 months, Jan 2010 - Mar 2011

    Manager, Global Regulatory Affairs and Global Label Manager

    Grünenthal GmbH

  • 1 year and 1 month, Dec 2008 - Dec 2009

    Regulatory Affairs Manager

    Accelsiors CRO

  • 1 year and 3 months, Sep 2007 - Nov 2008

    Regulatory Affairs Associate

    Accelsiors CRO

Ausbildung von Jasmina Savic

  • 5 years and 1 month, Jan 2012 - Jan 2017

    Drug Regulatory Affairs

    University of Wales

  • 4 years and 10 months, Oct 2002 - Jul 2007

    Pharmacy

    University of Novi Sad

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