March 29-30, 2019
The Quality Management System of clinical trials: complicated area in simple words
Reserve a place
March 29-30, 2019
The Quality Management System of clinical trials: complicated area in simple words
Training areas
  • Building of effective quality systems in a company: theory and practice
  • Workshop on writing SOPs for a CRO, a Sponsor, a vendor, and an investigational site
  • Implementation of risk-based approach in routine practice
  • CAPA auditing workshop: practical cases
  • FDA is coming: what to do?
For whom is this training
This course is intended for managers and experts in quality management, auditors, pharmaceutical companies and CRO employees, as well as for the investigators
Program
March 29-30, 2019
Day 1
09:00 – 09:15
Day 1
09:00 – 09:15
Registration
09:15 – 09:30
09:15 – 09:30
Course presentation. Main trends in the drug clinical trials market
Maxim Bunimovich, independent international GCP auditor, QA consultant,
trainer (TMQA)

09:30 – 10:30
09:30 – 10:30
International and local trends in legal regulation of clinical trials
10:30 – 10:45
10:30 – 10:45
Coffee break
10:45 – 12:30
10:45 – 12:30
The Quality Management System. Main elements. Theory and practice
12:30 – 13:00
12:30 – 13:00
Standard Operational Procedures. Theory
13:00 – 14:00
13:00 – 14:00
Lunch
14:00 – 15:30
14:00 – 15:30
Workshop on writing SOPs for a CRO, a Sponsor, a vendor, and an investigational site
Eugeniy Rogov, independent GCP consultant, auditor, and trainer
15:30 – 17:30
15:30 – 17:30
Employees training as an element of the Quality Management System. Main elements. Theory and practice. Immersion in real-world cases
Day 2
09:00 – 10:30
Day 2
09:00 – 10:30
Risk analysis in clinical trials. Preparation of the risk mitigation plan for a project
10:30 – 10:45
10:30 – 10:45
Coffee break
10:45 – 12:00
10:45 – 12:00
Discrepancies management. CAPA (Corrective and preventive actions plan). Real-practice cases
Maria Leer, clinical research quality assurance manager in one the largest global
pharmaceutical companies

12:00 – 13:00
12:00 – 13:00
Audit. Main types of audits in clinical trials and their characteristics
13:00 – 14:00
13:00 – 14:00
Lunch
14:00 – 15:30
14:00 – 15:30
Audit conduction workshop. Role play. Immersion in real-world cases
15:45 – 17:30
15:45 – 17:30
Regulatory inspections (EMA, FDA, Federal Service on Surveillance in Healthcare and Social Development of Russian Federation). How to prepare the investigational site and CRO. «FDA is coming» workshop
Dmitriy Manuilov, R&D Head in Maxwell, a Russian company
17:30 – 18:00
17:30 – 18:00
Questions and answers. Round table. Final exam. Certificates giving.
What to expect
New paradigm
We will shift the paradigm of your
understanding of the quality management
Working methods
New methods to create an effective, simple system not overloaded with complicated procedures
Practical knowledge
New knowledge on quality management
Fresh vision
New vision of old quality management
principles
Tranquility
You will be calm before any audit as you
know what to expect
Certificate
A certificate signed by The Research Quality Association (UK) members, valid in Russian Federation and EEU
Our team
Key experts in clinical trials conduct, quality
assurance, quality control, and 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
Maria Leer
Manager
Clinical research quality assurance manager in one the largest global pharmaceutical
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
March 29-30, 2019
Two days of new knowledge, methods and hints for your work
Starting at RUR 30 000
The price is RUR 30 000 for a physical
person and RUR 38 000 for legal entities. Group discounts
Best Western Vega hotel
71, bld. 3B Izmaylovskoye shosse
Moscow
Reserve a place
More questions? Send us a message to
trainingcenter@crptrials.com or call
+79218760091
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