Jasmina Savic

Jasmina Savic Email and Phone Number

Founder and Managing Director at Phortas GmbH @ Phortas
Jasmina Savic's Location
Aachen, North Rhine-Westphalia, Germany, Germany
Jasmina Savic's Contact Details

Jasmina Savic personal email

n/a
About Jasmina Savic

Founder and Managing Director at Phortas GmbH.I have extensive experience in global drug development and registration and have worked with numerous companies and experts during my career.

Jasmina Savic's Current Company Details
Phortas

Phortas

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Founder and Managing Director at Phortas GmbH
Jasmina Savic Work Experience Details
  • Phortas
    Managing Director
    Phortas Sep 2017 - Present
    Aachen, Germany, De
    Phortas provides a world-class product development support.Phortas is uniquely positioned to provide you access to the best expertise and to ensure you meet all requirements while developing your products.At Phortas we support your development programs by the core competencies that define our success:***World-class expertise: Our experts are established professionals in their field and truly dedicated to assigned projects​***Fast acting: We can define the project scope and provide our support immediately​​***Flexibility: We support our clients in ad-hoc, short-term or long-term projects, using a staggered approach in addressing all client needs Interested to work with us? Contact us at:info@phortas.com+49 (0) 241 942 69 101
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  • Js Regulatory
    Regulatory Affairs Consultant
    Js Regulatory Apr 2014 - Present
    -Global Regulatory Strategy-Authority meetings and preparation (FDA, EMA, PMDA, HealthCanada)-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/submission/management (national and voluntary harmonisation procedure-VHP)-Post-marketing life-cycle activities (variations, PSURs, etc.)-Labeling activities (CCDS updates, SmPCs/PILs, etc.)-Writing/critical review of submission relevant documents for EU, USA, Japan: 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.
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  • Grunenthal Gmbh
    Manager, Global Regulatory Affairs (Development)
    Grunenthal Gmbh Apr 2011 - Mar 2014
    Aachen, De
    -Regulatory Strategy development and execution-Pediatric Lead-FDA and EMA scientific advice team preparation and execution-Liaison with partners and CROs-CCDS creation and update; USA and EU label updates-MRP, DCP and national procedures-Oversight of eCTD creation and update-Submission and approval of clinical trials-Due diligence of potential new projects-Review of all relevant regulatory development documents
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  • Grunenthal Gmbh
    Manager, Global Regulatory Affairs And Global Label Manager
    Grunenthal Gmbh Jan 2010 - Mar 2011
    Aachen, De
    -Global Lead for mature products-Life-cycle management worldwide (variations, renewals, PSURs, etc.)-Gap analysis-Labeling Lead (CCDS oversight and local labeling compliance)-DCP, MRP and national procedures
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  • Accelsiors Cro & Consultancy
    Regulatory Affairs Manager
    Accelsiors Cro & Consultancy Dec 2008 - Dec 2009
    Baar, Zug, Ch
    -Management of multi-country clinical trials-Creation of department relevant SOPs and procedures-TMF filing and gap analysis
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  • Accelsiors Cro & Consultancy
    Regulatory Affairs Associate
    Accelsiors Cro & Consultancy Sep 2007 - Nov 2008
    Baar, Zug, Ch
    -Supporting managers in managing regulatory aspects of clinical trials
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Jasmina Savic Skills

Regulatory Affairs Regulatory Submissions Pharmaceutical Industry Clinical Trials Cro Gcp Clinical Development Ectd Regulatory Requirements Ich Gcp Pharmacovigilance Medical Writing Ctms Drug Development Sop Therapeutic Areas Generic Programming Clinical Monitoring Good Clinical Practice

Jasmina Savic Education Details

  • University Of Wales
    University Of Wales
    Regulatory Affairs
  • University Of Novi Sad, Faculty Of Medicine, Serbia
    University Of Novi Sad, Faculty Of Medicine, Serbia
    Pharmacy

Frequently Asked Questions about Jasmina Savic

What company does Jasmina Savic work for?

Jasmina Savic works for Phortas

What is Jasmina Savic's role at the current company?

Jasmina Savic's current role is Founder and Managing Director at Phortas GmbH.

What is Jasmina Savic's email address?

Jasmina Savic's email address is ja****@****ail.com

What schools did Jasmina Savic attend?

Jasmina Savic attended University Of Wales, University Of Novi Sad, Faculty Of Medicine, Serbia.

What skills is Jasmina Savic known for?

Jasmina Savic has skills like Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Clinical Trials, Cro, Gcp, Clinical Development, Ectd, Regulatory Requirements, Ich Gcp, Pharmacovigilance, Medical Writing.

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