Dr. Irina Golovacheva oversees the regulatory process from the initial study submission and receiving an approval up until end of study notifications for each project conducted by GCT in Russia. Irina is located in Moscow, within easy reach to the Ministry of Health and other agencies. Her responsibilities comprise of filing necessary applications, ensuring control of all Sponsor’s study documents to be submitted to the state regulatory bodies, and further – handling all interactions with MoH, Rosdravnadzor (Federal Service for Surveillance in Healthcare) and other authorities. Irina dedicates a fair share of her time for research to stay on the cutting edge with changes in the clinical trials regulations, combining it with regular participation in industry trainings and official seminars on the same topic. These facts, put together with her critical thinking ability and detail-oriented approach assure 100% successful regulatory track record for GCT and our Sponsors.
Dr. Golovacheva has extensive background in the Russian healthcare and pharmaceutical industry. Previously, she held positions in Regulatory Affairs and Pharmacovigilance for local CRO and Pharma companies and prior to that was involved in scientific research at the “Scientific Centre of Children Health” institution under the Russian Academy of Medical Sciences for almost a decade. She graduated with a medical degree from Moscow Medical Academy n.a. I.M. Sechenov, the oldest and the largest national medical higher educational institution in the Russian Federation.
We are proud to announce that this year our company turns 15! We are grateful to everyone who helped us get there: our clients, partners and employees.
To celebrate this accomplishment, throughout the year we will feature 15 publications devoted to our team members. Our success is due to their day-to-day contribution and effort. Thank you, GCT team, and keep up the good work!
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— September 19th, 2016 —
GCT is pleased to announce that the approval for a Phase II UC clinical trial was granted by the Russian Ministry of Health. The Investigator meeting will take place first week of October to gather all parties involved in the trial for a thorough training on the protocol and specific study procedures.
— July 14th, 2016 —
We would like to thank everybody who came to GCT party to celebrate our 15th anniversary during the DIA meeting last month, and especially our Partners and Clients – without you we wouldn’t be here. Cheers and we look forward to many successful years together!