Maxim Mily

Maxim Mily

Minsk, Belarus

Maxim Mily

Medical Affairs / Health Economics & Market Access
- Preparation of CTD modules (clinical overview, clinical summary, clinical study reports) or EAEC compliant equivalents/ English or Russian versions
- Preparation of pharmacovigilance instruments (PSUR, RMP)/EMA and EAEC compliant/English or Russian versions
- Development of health economic models, preparation of EDL dossier/English or Russian versions

Working hours

  • Monday:08h00 To 18h00
  • Tuesday:08h00 To 18h00
  • Wednesday:08h00 To 18h00
  • Thursday:08h00 To 18h00
  • Friday:08h00 To 18h00
  • Saturday:Not available
  • Sunday:Not available
  • Medical Writing, Health Economic evaluations
    - Preparation of CTD modules (clinical overview, clinical summary, clinical study reports) or EAEC compliant equivalents/ English or Russian versions - Preparation of pharmacovigilance instruments ...
Management of drug therapy and pharmaceuticals supply.
- Maintenance of drug formulary system;
- Development of local treatment protocols;
- Monitoring of pharmaceuticals utilization;
- Planning of pharmaceuticals provision;
- Safety monitoring, adverse reactions reporting;
- Clinical consultations in difficult cases, signatory role for administration of pharmaceuticals from restricted list;
- Education of internal clients in phermacotherapy questions;
- Interactions with pharma industry.
Upgrading and maintenance of MAH Pharmacovigilance System, deputy QPPV.
Responsibilities for running of all critical PhV processes:
- Registration and processing of individual sponteneous adverse events reports;
- Identification and processing of safety signals;
- Literature monitoring;
- Preparation and revision of pharmacovigilance documents (RMP, PSUR, Master-File, SOP)
- Training of personal and external partners et c.
Communications with regulatory agency.
Main responsibilities.
• Expertize of dossiers submitted for registration, confirmation of registration, and variations
• Expertize of pharmacovigilance documents (PSUR, RMP)
• Preparation of responses for inquiries from health care organizations and other authorities
• Participation in development of regulatory documents
Main responsibilities.
• Interactions with OLs
• Preparation and delivery of product and general trainings, promotional materials for field force;
• Approval of promotional and none-promotional materials;
• Revision and approval of clinical overview and clinical summary of registration dossier, SPCs, PILs;
• Initiation and coordination of clinical trials with company products in countries of presence, publications management; presentations on scientific governings;
• Conduction health economic evaluations for company products for markets under responsibility;
• Preparation of EDL and formulary submissions;
• Commercial assessment of products planned for launch, estimation of pharmacoeconomically grounded price.
Main responsibilities.
Market access activities:
• Development and execution of market access strategies for existing and planned products; preparation of EDL and formulary submissions
• Conduction of attributable for Belarus health economic evaluations, creation of cost-effectiveness and budget-impact models for Amgen products
• Contacts with KOLs and payers, publications management; presentations on scientific governings.
Business development activities:
• Commercial assessment of products and medical devices (market analytics, evaluation of disease epidemiology and current therapeutic practice, preliminary economic evaluations and pricing, sales forecasting)
◦ from portfolios of existing partners (Amgen, Orkla, CookMedical)
◦ proactive search for perspective products and partners
Main responsibilities:
• Creation of health economics part of dossiers for inclusion in EDL and other lists;
• Planning, organization of involvement of third-party vendors, monitoring and appraisal of pharmacoeconomics evaluations of company products;
• Management of publications and presentations on pharmacoeconomic evaluations of company products;
• Building of relations with KOLs in the field of health economics;
• Organization and conduction of educational and scientific event with market/access health economics agenda;
• Delivery of trainings in general questions of health economics and evaluations of the products for company personal;
• Development, implementation, and maintenance of interactive Market Access Tool for iPAD
• Support of global brand teams in operations in the field of Health Economics;
Main responsibilities:
• Preparation and delivery of product and general trainings for field force;
• Preparation of promotional materials;
• Medical writing (clinical overview and clinical summary of registration dossier, SPCs, PILs);
• Safety surveillance for company products;
• Information support for internal and external clients;
• Initiation and coordination of clinical trials with company products in countries of presence, contacts with OL;
Participation of preparation of formulary submissions in countries of presence.
Courses: “Economic Evaluation of Pharmaceuticals and Medical Technologies (1): Basic Concepts “, “Quantitative Techniques Applied to Health Service and Pharmacy Management “, “Economics and Policies of Pharmaceutical Financing”, “Economic Evaluation of Pharmaceuticals and Medical Technologies (2): Advances”, “Drug Management in Health Systems “. 37,5 ECTP
Courses taken: “Public Health”, “Biostatistics”, “Epidemiology”, “Health Economics”. Master thesis: “Application of drug formulary for optimization of pharmaceuticals financing, accessibility, and utilization in hospital setting in Belarus”. 120 ECTP.
Doctoral degree in clinical medicine, specialization in internal diseases (1998)
Master Degree (clinical residence) in clinical pharmacology (2000)
  • MPH Diploma 24/09/2024
  • Clinical REsidence 30/06/2020
  • Postgraduate diploma in pharmacoeconomics 30/09/2013
  • MD Diploma 24/06/1998
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