Ihar Batalevich
Owner
Independent consulting
ASM
Belarus
Biography
Managed regulatory consulting for full range of medical products â— Development of regulatory budget and plans â— Checking of registration dossier for compliance with local requirements â— Organization of samples import with customs clearance â— Organization of Health Authority inspection of production facility (Good Manufacturing Practice/Quality Management System audit) â— Leading of regulatory team â— Ensured project team fulfill of their project responsibilities in accordance with defined project plan â— Establishment of pharmacovigilance department â— Creation of pharmacovigilance Standard Operation Procedures â— Pharmacovigilance consulting â— Pharmacovigilance personnel trainings â— Organization of local quality assurance system to avoid stop-sales due to regulatory discrepancies â— Sales operations for medical devices and medicines â— Communication of key decision makers to promote target products â— Negotiations with Health Authority functionaries to include target products to state formularies and protocols â— Cooperation with state distributor companies to ensure product’s purchasing â— Comprehensive analysis of possible partner to ensure full correspondence of current plans â— Market analysis â— Analysis of portfolio
Research Interest
Expert consultations on case of tender business â— Choosing of products for state tenders â— Expert consultations in case of market access â— Marketing plan’s creation for hi-tech, hi-special and orphan products
