Ihar Batalevich

Biography

Managed regulatory consulting for full range of medical products ● Development of regulatory budget and plans ● Checking of registration dossier for compliance with local requirements ●  Organization of samples import with customs clearance ● Organization of Health Authority inspection of production facility (Good Manufacturing Practice/Quality Management System audit) ● Leading of regulatory team ● Ensured project team fulfill of their project responsibilities in accordance with defined project plan ● Establishment of pharmacovigilance department ● Creation of pharmacovigilance Standard Operation Procedures ● Pharmacovigilance consulting ● Pharmacovigilance personnel trainings ● Organization of local quality assurance system to avoid stop-sales due to regulatory discrepancies ● Sales operations for medical devices and medicines ● Communication of key decision makers to promote target products ● Negotiations with Health Authority functionaries to include target products to state formularies and protocols ● Cooperation with state distributor companies to ensure product’s purchasing ● Comprehensive analysis of possible partner to ensure full correspondence of current plans ● Market analysis ● Analysis of portfolio

Research Interest

 Expert consultations on case of tender business ● Choosing of products for state tenders ● Expert consultations in case of market access ● Marketing plan’s creation for hi-tech, hi-special and orphan products