Ekaterina Mochalova

Drug Registration and ICH-GCP Clinical Trials in Russia since 2009. Pharmaceuticals, biological products, food supplements, pharm. substances/APIs Articles https://www.pharmaceuticalprocessingworld.com/the-challenges-and-opportunities-of-a-foreign-drug-registration-in-russia/ https://www.prnewswire.com/news-releases/why-the-russian-pharmaceutical-market-is-attractive-for-foreign-generics-ars-pharmrussia-explains-300655068.html Others

Visiting Assistant Professor of Practice and Co-Instructor for the Course on Clinical Trials. Postgraduate Course “Clinical Trials as an essential part of the innovation process in the pharmaceutical development”, Academic Year 2014-2015. Lectures on Government Regulations of clinical trials in the US, EU, and Russia; Budgeting clinical trials; others.

US-headquartered CRO. GCP/FDA/EMA compliant Phase I-IV / PK clinical research for pharmaceuticals and biologics (novel drugs, biosimilars and generics) in Russia, Ukraine, Romania, and Bulgaria since 2001. CNS (neurology, psychiatry), oncology, ophthalmology, women's health, GI, etc. Orphan drugs. Medical devices. Article: https://journalforclinicalstudies.com/cns-clinical-trials-russia/

Finding new clients through introduction of R&D companies looking for financing clinical trials to investors (PE, VC, business angels, banks, Big Pharma, others) and ready to provide equity/project financing, licensing opportunities. Potential clients' clinical trials program cost estimation for preparing financial request to investors. IR development / building strategic alliances with venture capital companies, PE, institutional and corporate investors focused on healthcare, life science industry

Relations with clients - pharmaceutical, biotech, medtech companies interested in clinical trials conduct in CEE; creating and negotiating proposals, presentating the company at professional business events and face-to-face meetings; developing new business directions (clinical trials for medical devices and radiopharmaceuticals; Russian Pharma relations development); participation in the company’s advertising campaign, development of relations with healthcare regulatory authorities, others

Seminars with students on financial disciplines: Corporate Finance, Financial Management, Budgeting. Supervision over degree work conduct by graduating students

Project specific reimbursable / pass through expenses accounting, analysis, and reporting

Ph. D. thesis on the subject of “Financial planning in contract research organizations” Abstract: https://economy-lib.com/disser/394807/a#?page=1

Marketing, Macro/Microeconomics, Corporate finance, Securities, Taxes/tax planning, Analysis of economic activities, Accounting, International finance, Banking, Payment systems, Cash-flow management, Financial planning, Budgeting, Financial management, Strategic planning, Crisis-proof management