Jasmina Savic Email & Phone Number

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

-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.

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

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

Baar, Zug, Ch

-Management of multi-country clinical trials-Creation of department relevant SOPs and procedures-TMF filing and gap analysis

Baar, Zug, Ch

-Supporting managers in managing regulatory aspects of clinical trials

Master Of Science (Msc), Regulatory Affairs

Master Of Science (Msc), Pharmacy