Maria Dimitrova Email and Phone Number
I am legal and compliance professional with deep knowledge for healthcare and pharmaceutical sector. I have taken different positions in general management, corporate strategy, market access, government affairs, consultancy, legal and compliance in multinational companies.Currently I work actively on different policy shaping projects with local trade association and I support them in drafting legislative proposals and opinions. I am also part of local country engagement team working on European Pharma Strategy, preparing industry perspective statements and building advocacy tools. I also contribute to execution of local industrial Code of Ethics. After joining the team of NKN Law, I participated in preparation of the defence strategies for cases in healthcare sector. As part of the team I consult clinical trial projects (incl. preparation and revision of contracts, ICFs revision and adaptation, consultations on specific GCP compliances topics and ethical assessments), market access cases, administrative proceedings. I also support Bulgarian Association on Qualified Persons by consulting them on different regulatory topics.PUBLICATIONS2017, How far goes the freedom of parallel trade with pharmaceutical products, G. Kalinov, M. Dimitrova, Capital Newspaper, May 20172018, Compassionate use programs, Capital Newspaper, May 2018 2019, Alternative Access to Medicinal Products, Publication in Applied Pediatrics Magazine.2021, Co-author of the book on New Era in the Medicine: Gene Therapies2021, Vaccines and adverse drug reactions - liability discussion issues, M. Sharkova, M. Dimitrova, https://defakto.bg/2021/02/02/vaksini-i-nejelani-lekarstveni-reakts/2023, Legislative approaches for solving medicinal products shortages, https://defakto.bg/2023/01/30/adv-mariya-dimitrova-za-vazmojnite-zak/2024, Execution of individual administrative acts of National Council on Pricing and Reimbursement, Medical Law and Healthcare
Nikolova, Kalinov & Partners
View- Website:
- nknlaw.com
- Employees:
- 11
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Legal And Compliance, Associated PartnerNikolova, Kalinov & PartnersSofia, Bg
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Head Legal Expert, Associated PartnerNikolova, Kalinov & Partners Jan 2017 - PresentSofia, Sofia City, BulgariaFor more details, please visit www.nknlaw.com. -
Head Of Market AccessNovartis Jan 2012 - Jul 2016Bulgaria• Lead of market access, government affairs, pricing and corporate affairs team.• Setting the strategic direction for future development of Novartis portfolio.• Reimbursement submissions and pricing negotiations with healthcare authorities.• Government affairs- establish relationship and communication with policy makers, payers and budget holders- Sick Fund, Ministry of Health, Governmental Committee of Health, Physician`s Union, NGOs, healthcare policy shaping. • Develop and support value propositions and value communication strategy.• Analyse payer, customer, and patient economic drivers and barriers. • Provide health economics analysis- cost-effectiveness and budget impact models.• Develop and maintain relation with patient groups, create PSP programs.• Create public affairs plan, execute social responsibility programs, Participate and lead policy shaping activities of local trade association and build industry capabilities of forming stable partnership with state bodies. • Develop and implement the concept for managed entry agreements in Bulgaria. Initiate signing of fist MEA with local health fund for reimbursement of company product. -
Business Development ManagerAlapis Bulgaria Eood Mar 2009 - Jan 2012Sofia City, Bulgaria• Prepare the company for receiving wholesaler license. • Develop country strategic approach and portfolio management. Negotiate agreements for pre-wholesale services with several multinational pharma companies. • Responsible for country P&L performance and development, forecasting • Develop and maintain a positive interface with industry associations, governmental bodies, wholesalers in-country and other key external stakeholders• Attract and develop local talent and manages performance, co-creating/implementing capability plans and ensures sustainability of business performance through short and mid-term success planning. Develop relations with local key opinion leaders and support pharma partners in strengthening their products market presence. -
Business Development - External PartnersActavis - Eine Marke Der Teva Oct 2008 - Mar 2009Sofia, Sofia City, BulgariaFurther development of company capabilities and team preparedness for negotiating, management and execution of outsourced products. Creating internal policies and implementing operational procedures for smooth execution of company contracts for marketing of external products. -
Project Manager - Multiple SclerosisActavis - Eine Marke Der Teva Jan 2008 - Oct 2008Sofia, Sofia City, BulgariaBuilding internal capabilities and supervising the execution of contracts for multiple sclerosis products which were outsourced to the company in Bulgaria. Building relations with key opinion leaders, shaping team strategy for enforcement of product market positioning. Development of patient support programs and supervising market tendencies.
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Product Management ConsultantActavis - Eine Marke Der Teva Sep 2007 - Jan 2008Sofia, Sofia City, BulgariaConsultation to the executive team of the company in relation to a newly created structure focused on negotiating with multinational pharmaceutical companies on agreements for original products divestment to Actavis for outsourced marketing in Bulgaria.
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Product ManagerGenesis Pharma Nov 2006 - Sep 2007Sofia, Sofia City, BulgariaDevelopment of product strategies in multiple sclerosis market. Initiate different patient support programs. Support company relations with key neurologists, preparation and support of different scientific events in the field of multiple sclerosis and cystic fibrosis. Support and development of relation with local patient organisations. -
Regulatory SpecialistGenesis Pharma Apr 2004 - Nov 2006Sofia, Sofia City, Bulgaria- Supporting regulatory status of pharmaceutical products - submission of local dossiers, preparation of variation and renewals of marketing authorisations. - Preparation of local pricing strategy, submission, approvals and maintenance of local price registration for different pharmaceutical products. Coordination with countries from referent basket. - Monitoring and implementation of local legislation regarding achievement of products national reimbursement, inclusion in national programs for reimbursement and preparation of participation in state tenders.- Negotiations with local state authorities.
Maria Dimitrova Education Details
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Master Degree -
Chemical Technologies
Frequently Asked Questions about Maria Dimitrova
What company does Maria Dimitrova work for?
Maria Dimitrova works for Nikolova, Kalinov & Partners
What is Maria Dimitrova's role at the current company?
Maria Dimitrova's current role is Legal and Compliance, Associated Partner.
What schools did Maria Dimitrova attend?
Maria Dimitrova attended Faculty Of Public Health, Medical University - Sofia, University Of Chemical Technology And Metallurgy, University Of Ruse.
Who are Maria Dimitrova's colleagues?
Maria Dimitrova's colleagues are Mm Kk, Dinda Nabila, Ldnfñal Kslfnel, Paul Chweya, Ahmetwaly Top, Gjhk Nkkn, Nadia Galuh Mauratu.
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