Vladimir Seredyuk, QA Director, conducted a refresher Good Clinical Practice course at Russian head office today in order to keep the team up to date with the most important principles.
GCT Quality Assurance (QA) system comprises internal standard operating procedures (SOPs) and working instructions which are continuously monitored, maintained and improved. The Quality in our procedures and services provided is ensured by:
- Continuous training of personnel including assessment and compliance controls;
- The strict implementation of our Standard Operating Procedures (SOPs);
- Internal audits at regular intervals and audits conducted from our clients;
- Implementation of a CAPA system with root cause analysis and close follow up as a way towards improvement and effectiveness of the – Quality assurance system;
- Standard Operating Procedures (SOPs) are documented for all tasks.
Updated: December 27th, 2017
Today Vladimir Seredyuk, MD, Quality Assurance Director conducted internal on-site audit of GCT warehousing facility in Saint-Petersburg, Russia. We are happy to announce that no major findings were revealed.
Please contact our BD department to obtain detailed and personalized information on the list of services of GCP/FDA compliant warehousing in Russia.
Updated: December 26th, 2017
Merry Christmas, dear friends and colleagues!
Updated: December 25th, 2017
The scent of mandarins filled GCT Russian office this Wednesday morning. On December 20th for many years we celebrate our colleague, friend and irreplaceable GCT Event Manager, Anton Romanov. Dear Anton, we value your support, ideas and guidance and wish you to enjoy this day and have thousands of beautiful events ahead.
Updated: December 20th, 2017
Last Thursday, December 14th, Vladimir Seredyuk, MD, represented GCT Quality Assurance Department in Skolkovo Innovation Center. Networking with QA experts in the region is not only about meeting new prospect, but about sharing the best practices in this constantly developing field.
In his speech, Dr. Seredyuk shared his personal experience of passing the inspections of the FDA, EMA, Roszdravnadzor and the State Expert Center of the Ministry of Health of Ukraine.
All the participants of the forum demonstrated a very high professional level during the presentations and discussions. The statistics on the results of the findings of the regulatory inspections by the FDA, EMA, MHRA and Roszdravnadzor for year 2016 were presented and considerable attention was paid to the Risk-based Approach in the light of the requirements of the new edition of ICH GCP E6 (R2), the introduction of Risk-based Approach into real practice in the local market of clinical research, conducting audits in a hybrid monitoring model, risk-based approach to validation of electronic data. One of the presentations was devoted to the protection of personal data in the Russian Federation and the EU. Another important topic of discussion was on the achievement of the continuity of business. The forum showed the urgency for creating a professional organization of QA workers in Russia. A discussion was initiated to find solutions and will be continued on the electronic quality assurance forum (eaquality.org).
Updated: December 18th, 2017
GCT CEO, Eugene Selivra, MD and GCT Senior Manager BD, Nataliya Katsnelson, attended a wonderful event at The Nassau Club in Princeton this Wednesday evening organized by the PNC bank. We are delighted to have more than 13 years of continuous cooperation with the bank. Nice music, cocktails and friendly atmosphere – everything is just perfect for networking with local business owners and other professionals in the area.
Updated: December 8th, 2017
Quality Assurance Forum will take place on December 14, 2017 in Skolkovo Innovation Center. The Forum provides a platform for discussion, professional development and exchange of experiences among the QA specialists in pharmaceutical industry – preclinical and clinical research, drug development and pharmacovigilance.
Vladimir Seredyuk, MD, GCT QA Director, has successfully passed a number of EMEA and FDA inspections and completed the auditing course to become a QA professional. Mr. Seredyuk is a welcome guest at the Forum and he is going to share with the participants the comparative experience of passing different regulatory inspections in Russia and Ukraine, FDA and EMA in CROs and research centers.
GCT has passed over 60 external project and system audits and can boast its QA system. For instance, in 2017 GCT has successfully passed 3 project related audits.
Updated: December 5th, 2017
Updated: November 28th, 2017
Next week promises to be full of opportunities for growing Indian Pharma Industry. India Pharma Week welcomes over 50,000 pharma professionals from 122 countries. It is a good platform for Knowledge, Innovation, Recognition and Networking in the drug development business.
Are you planning to conduct your next trial in India? GCT offers CRO services in those countries and has accumulated strong background across the wide range of therapeutic areas. If you are keen to have an interaction or face to face meeting, make an appointment with GCT Managing Director, Dr. Umakanta Sahoo, in CPhI conference. Please contact Dr. Sahoo directly at firstname.lastname@example.org and discuss your plans and the possibility of introducing your products to the foreign markets.
Updated: November 23rd, 2017
Last week GCT President Dr. Jeffrey Apter attended the annual CNS summit in The Boca Raton Resort & Club Boca Raton, Florida, USA.
CNS Summit’s programs and initiatives are designated to shape the future of clinical trials and drug development. The Summit is known for its innovative content and format, as well as the strong emphasis on collaboration between leaders from pharmaceutical and biotech companies, research sites, and service companies to solve pressing challenges in drug development.
Over the years GCT has gained a great experience of conducting clinical trial in CNS field in Central-Eastern Europe and India. We are closely familiar with key opinion leaders in this therapeutic area, as well as experienced investigative sites and patient organizations and we will gladly apply this knowledge to assure the successful completion of your planned clinical program.
Updated: November 22nd, 2017
First day flew fast at the Kiev Clinical Research Forum. If you missed our president’s talk on the Disease Modifying Trials in Alzheimer, then come hear his presentation on Overcoming the challenges of conducting CNS Studies in Ukraine and EE tomorrow, November 10th at A+C Hall, 1st Floor, 13:30 – 14:00. Jeffrey Apter will be happy to chat on how we can assist you in bringing your clinical trials to our regions.
Updated: November 10th, 2017
Thursday, November 9 is the day to celebrate achievements and raise awareness of how quality, internal systems and processes’ improvement can make a resounding impact on company reputation and profitability. When applied to organizations, quality is always an outcome – a trait of a product or service provided to a customer.
GCT has passed over 60 external project and system audits, and can boast its QA system, which is based on:
✔The strict implementation of our Standard Operating Procedures (SOPs).
✔Continuous training of personnel including assessment and compliance controls;
✔Internal audits at appropriate time intervals and audits conducted by our clients;
✔Implementation of a CAPA system with root cause analysis and careful follow-up, as a way towards the improvement of our Quality assurance system.
✔Established Vendors’ qualification process.
✔SOPs are documented for all tasks and services and review.
Request a free feasibility for any clinical trial in Russia, India or Central-Eastern Europe by contacting email@example.com
Updated: November 9th, 2017
Aleksandr Stiblo, GCT Business Development Manager, is participating today at the VII International forum “Life Sciences Invest. Partnering Russia” in St. Petersburg, Russia.
It became a good tradition for Life Science experts to exchange their experience and discuss current trends in the development of pharmaceuticals in the Russian Federation. More than 350 participants are attending the forum. Here you can meet executive officials, like the Governor of St-Petersburg Georgiy Poltavchenko, top-managers of pharma companies, scientists and researchers.
The forum highlights the need of interdisciplinary approach to the development of drugs and the main trends in the scientific research related to chemical and biological synthesis. The Forum is the launch site for a number of initiatives and joint implementations of the projects in the field of education and science where the official award ceremonies held among the best Life Science students and teachers.
Please contact firstname.lastname@example.org to arrange a meeting with Aleksandr.
На этой неделе менеджер по развитию бизнеса Александр Стибло принимает участие в VII Международном партнеринг-форуме Life Sciences Invest.Partnering Russia в отеле Талион Империал в Санкт-Петербурге.
Форум традиционно объединяет специалистов в области Life Sciences, представителей власти, топ-менеджеров и руководителей ведущих компаний отрасли. Основной темой форума являются вопросы межотраслевого взаимодействия при разработке и производстве лекарственных средств, а так же перспективы развития технологических платформ в области химического и биологического синтеза. В рамках Форума запланировано подписание ряда соглашений о сотрудничестве и совместной реализации проектов в сфере образования и науки, в том числе с международными компаниями, а также награждение победителей среди лучших студентов и преподавателей.
Updated: November 8th, 2017
In the beginning of November, worldwide leaders in the treatment of Alzheimer’s disease and sites’ clinical trial teams shared the results, methodologies, therapeutic options, and challenges that were brought to the industry recently. This year CTAD dialogues revolved among important topic of the necessity to understand how we can predict the risk of AD progression. The participants presented results of their preclinical research, Phase II and Phase III multinational trials.
Having participated as Principal Investigator in over a 100 trials in Alzheimer’s Disease, Jeffrey was a welcome guest at this meeting. Dr. Apter, his colleagues and fellow researchers discussed innovative solutions, study design issues, promising current developments and future trends of clinical trials, – including clinical trials conducted in the Eastern Europe, Russia and India.
Updated: November 7th, 2017
Today our Legal Director, Irina Ryzhkova, M. Sc. and our business development manager, Aleksandr Stiblo are attending “The Real Way from Developments to Medicines” conference at Pirogov Medical University in Moscow, Russia. Irina is giving a speech on the important topic of clinical trial agreements set-up, describing core terms, conditions and responsibilities of the key parties involved.
Updated: November 2nd, 2017
Each year, Galien Medstartup gets together executives and inspiring leaders that work together to improve the state of human health. This year 50 start-ups and well established companies from France and Israel were selected for their innovative solutions to participate in the Galien MedStartUp Partnering day, organized by The Galien Foundation and Business France.
GCT Team was honored to be invited to network with the international and local industry leaders. As an international company we find this event exceptional and productive in building valuable relationships within the Pharma/MedTech/Digital Health industries.
Updated: October 31st, 2017
Last week Roxana Darie, MBA, General Director/Legal Affairs of GCT Romanian office visited the National Congress for Clinical Research (CNCCR 2017) in Bucharest. This key industry event was organized by the Carol Davila University of Medicine and Pharmacy with the participation of the Ministry of Healthcare, the Bucharest College of Medical Doctors, the NMAMD (National Agency for Medicines and Medical Devices), the Bioethics Committee, the European Medical Writers Association, the Association of the Companies Coordinating Clinical Trials in Romania and the Romanian Association of International Medicine Manufacturers. (more…)
Updated: October 24th, 2017
Diwali, or Dipavali, is India’s biggest and most important holiday of the year. The festival gets its name from the row (avali) of clay lamps (deepa) that Indians light outside their homes to symbolize the inner light that protects from spiritual darkness. This year Diwali will start on Wednesday, the 18th of October and will continue for 5 days until Sunday, the 22nd of October. (more…)
Updated: October 18th, 2017
Irina Golovacheva, MD, GCT Regulatory Manager, participated at the XIX Annual Russian National Conference “State regulation in the field of the circulation of medicines and medical products – PharmMedManagement 2017” that has taken place in Moscow, Russia October 16 – 17.
This year conference hosted multiple discussions with the Russian and foreign regulatory authorities, international research and public organizations, professional associations and manufacturers during the roundtables, plenary and breakout sessions about quality control of medicines, clinical trials conducted in Russia and in the EAEU, pharmacovigilance, examination and registration of investigational products, labeling system, circulation of controlled drugs, psychotropic substances and their precursors, biomedical cell products and risk-oriented approach to circulation of medical devices.
These are just several topics of the event agenda that healthcare professionals have found interesting and important to consider to keep pace with modern healthcare trends.
Updated: October 17th, 2017