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TO WHOMIT MAY CONCERN:
It is my great pleasure to write this letter of recommendationfor Dr. Ekaterina Zareva
Borcheva-Dancheva.
I have had a pleasureof witnessingEkaterina'sprofessionaldevelopmentover the last five
years,andI canstatewith confidencethat sheis a motivated andresponsibleprofessional.
Dr. Borcheva-Danchevabeganworking for PSI asa Headof Regulatoryand Matrix Services,
which is a managerial role covering four functional areas: Regulatory Affairs, Clinical
Supplies, Translation Department and Document Center. With only minimal training,
Ekaterinamanagedto quickly graspthe essentialsof thejob, and sincethe very start shehad
beenworking with total precisionandabsolutededication.
In my capacityof a Senior Director, Regulatory Affairs at PSI CRO AG I feel that I know
Ekaterinaquite well. I washer direct managerand supervisor.We havebeenworking in close
cooperationon the developmentof the clinical trial submissionflows and safety reporting
procedures for Bulgaria, Greece and Turkey, preparation of an outline of regulatory
frameworksfor Macedonia,Cyprusand Iran, aswell ason the set-upandmaintenanceof 50+
multinational studies with participation of Bulgaria, Greece and Turkey.
Ekaterina developed business procedures and submission workflows with the focus on
regulatoryrequirernentsand safetyreporting aspectsfor clinical trials in Bulgaria, Greeceand
Turkey, and shetook part in training the personnelin chargeof submissionactivities in these
countries.
Ekaterina has also been trained as a EudraVigilance User and an in-house trainer for EV-
related processes.Here at PSI Ekaterina has been involved into the Medical Writing
processes,as well as into development and review of Document and Safety Management
Plansfor multiple multinational studies.
Ekaterinahasbeenvery much involved into developmentof PSI SOFDrug depotcapabilities
andmaintenanceof its functionality.
During her work at PSI, Ekaterinahasinvestedmuch effort into streamliningthe departmental
activities. Shewas involved into training new staff, andworked hard on a hand-overprocess
beforeleaving the company.
Ekaterinahas vast experienceand competencein different areas,such as feasibility, clinical
operations,regulatory affairs and safetyreporting. Sheis a smartand skilled personwith rich
professionalexperience.Shehas been always demonstratingthe ability to managemultiple
tasks and accomplish goals efficiently and on time; her work perfornance was consistently
strong.
Her role as a managerdemandedthat she work harmoniously with a wide range of people
while commandingrespect.Owing to her personality, Ekaterinawas able to accomplishthis
with relative ease.She had a positive attitude when dealing with both her supervisorsandl
subordinates.Ekaterinaalways displayeda responsibleattitudetoward herjob; shedemanded
a greatdealof herself,strivingfor thebestoutcomepossible.

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Ekaterinadid an excellentjob here,andwe aresorryto seeher go. I must admitthat it is
ratherdifficult to find a managerwho would possesssucha great combinationof strong
professionalskillsandnicepersonalqualities.
Forall of thesereasons,I think Ekaterinawill makea fineadditionto yourteam.Shouldyou
haveanyquestions,I invite you to contactme at my mobile:+7 (921)9486443or via my
businesse-mail(evgeniy.smirnov@psi-cro.com).
Sincerely,
EvgeniySmirnov
Sr.Director,RegulatoryAffairsatPSICROAG