December 10-11, 2018
Audit methodology in clinical trials
— practical workshop
— practical workshop
Training areas
- A unique opportunity to receive the newest
actual insider information about last
worldwide trends in methodology of clinical
trials auditing (investigational site audit, system audit, vendor assessment, TMF audit etc.) - To obtain and later use the helpful skills in clinical trials auditing
- To network with colleagues who work in clinical trials quality assurance ares
For whom is this training:
- Sponsor or CRO employees as well as investigators with clinical trials experience of at least 2 years
- Sponsor, CRO, or investigational site employees who want to obtain knowledge and skills of auditing and late use them in practice
- The training may be especially useful for the employees involved in the preparation for expected audits and regulatory inspections (including EMA, FDA, Federal Service on
Surveillance in Healthcare and Social Development of Russian Federation) in the CRO and investigational sites
- The training is in Russian, and its program is perfectly adapted to the requirements of legal regulation in the area of clinical trials in Russia
- Sponsor or CRO employees as well as investigators with clinical trials experience of at least 2 years
- Sponsor, CRO, or investigational site employees who want to obtain knowledge and skills of auditing and late use them in practice
- The training may be especially useful for the employees involved in the preparation for expected audits and regulatory inspections (including EMA, FDA, Federal Service on
Surveillance in Healthcare and Social Development of Russian Federation) in the CRO and investigational sites
- The training is in Russian, and its program is perfectly adapted to the requirements of legal regulation in the area of clinical trials in Russia
Our trainers
The training is performed with the informational support of an independent British company TMQA, which provides consulting services in the area of global clinical trials quality assurance, as well as with the organizational support of ICRPE- NACPP which provides a place for the training. The trainers are key experts in
clinical trials conduct, quality control and quality assurance, auditing, members of the British Association of Research Quality Assurance (RQA)
clinical trials conduct, quality control and quality assurance, auditing, members of the British Association of Research Quality Assurance (RQA)
Dmitriy Manuilov
R&D Head
R&D Head in Maxwell, a Russian company, with significant experience in product development, studies conduction, auditing, construction of quality assurance systems.
Maxim Bunimovich
Independent GCP consultant
QA consultant, trainer (TMQA), with significant experience in audits and inspections of investigational sites in
different countries worldwide, as well as practical experience in the construction of quality management systems for CROs and sites
different countries worldwide, as well as practical experience in the construction of quality management systems for CROs and sites
Maria Leer
Manager
Clinical research quality assurance manager in one the largest global pharmaceutical
companies
companies
Eugeniy Rogov
Independent GCP consultant
Auditor and trainer, former head of the clinical trials quality control of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation
December 10-11, 2018
Two days of new knowledge, methods and hints for your work
RUR 35 000
The price is RUR 35 000. Group discounts
IQ Park business center
2 bld.7 Ugreshskaya str
Moscow Ugreshskaya metro station
Moscow Ugreshskaya metro station
Reserve a place
More questions? Send us a message to
trainingcenter@crptrials.com or call
+79218760091
trainingcenter@crptrials.com or call
+79218760091
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