Ulrike Hartig

2024 TCC 2% award winner Medical Devices classes I to III and Medicinal products (Medical Surgical Prtfolio; Oral Care Portfolio); Israel (IL), Kazakhstan (KZ) IL: Medical Dev. classes I to III: new registration, amendment, renewal Medicinal products: Import of non-registered Medicinal product through Special Import Permit; assessment of Medicinal Product registration through conventional procedure and fast track (reliance) procedure KZ: Medical Dev. classes I to III: amendment, renewal; MOH sample pull

REMOTE POSITION MEDICINAL PRODUCTS (Rx, national licenses) - European Union: DE, AT, CZ, PL, NL, BE, IT, ES, PT - non European Union: AU-NZ, CA, UK, ZA, HK, LB, MY Variations type IA/IAIN, IB, II (CMC) through worksharing Procedures (EU-countries) and/or national procedure.

Medicinal Products (OTC, nat./DCP in DE/AT/CH): Variations (Type IA–II, worksharing, SmPC/CCDS), MA transfers (in CH during ongoing change) & renewals. ​Clinical Trials (DE): CTA filings, amendments, regulat. reporting obligations, and handling LZG sampling requests. ​Femcare (Commodities): Review & approval of mastertexts (DASHB) and promotional material (TV, web, social media). ​Compliance & Processes: Preparation for GMP/GxP inspections & audits; cross-functional project work for process optimization.

MEDICINAL PRODUCTS (Rx, individual prescriptions according to TAV “Therapieallergeneverordnung”/"therapy allergen ordinance" in DE) - Preparation and follow-up of non-interventional studies; - Preparation and follow up of GDP-inspections, GxP-audits; - Follow up of customer requests (by pharmacies, private customers); - Documentation and filing of adverse drug reaction reports; - Registration of HCP-trainings (incl. CME-points)

MEDICINAL PRODUCTS (Rx for use in hospitals incl. controlled drugs); aqueous solutions for parenteral use) - Preparation and review international regulatory submissions for ex-EU-countries (Latin America, Asian countries, Middle East, Russia, African countries) - Maintenance of existing marketing authorisation in ExEU regions: Renewals, Variations - Participation in tenders (e.g. Thailand) - Company registrations (Libya, GCC) - Response to MOH queries - Certificate of a Pharmaceutical Product (CPP)