KCR Presentation on Russia Great Potential for Clinical Trials, despite Complexities of the Regulatory System

1. Russia –
is it an accessible market
for international research and
development?
Nadezhda Ivaneeva, ma, mba
General manager
Russia & Kazakhstan

2. Disclaimer
The views and opinions expressed in the
following slides are those of the individual
presenter and should not be attributed to any
organization with which the presenter is
employed or affiliated.
These PowerPoint slides are the intellectual
property of the individual presenter and are
protected under the copyright laws of Poland.
Used by permission. All rights reserved.
All trademarks are the property of
their respective owners.
PAGE / 2 Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

3. AGENDA
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History, geography and few more interesting facts
Why conducting clinical trials in Russia
ACTO and its role
Regulatory timelines: law vs. reality
Regulatory approach and timelines by KCR
Few tips for successful study planning and conduction
Getting marketing authorization
Conclusions
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

4. History, geography and few more
interesting facts
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International clinical trials started in Russia in early
1990-s
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

5. Why conducting clinical trials in
russia (1)
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Centralized healthcare system, allowing to easier involve
patients in participation in clinical trials
Huge population (more than 140 millions, 73% live in
cities*)
Still lack of governmental programs and standards of
care for some diseases, especially in regions
Clinical sites are accredited by MoH for clinical trials
conduction (1030 accredited governmental and private
medical institutions on 11Jun2014**)
Principal Investigators are GCP trained and to have no less
than 5 years of experience in clinical trials
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva
* Source: Wikipedia
** Source: http://www.grls.rosminzdrav.ru

6. Why conducting clinical trials in
russia (2)
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Market potential (Source: www.clinicaltrials.gov on 16 Jun 2014)
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

7. Why conducting clinical trials in
russia (3)
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KCR exposure to Request for Proposals (RFPs), which
included Russia
RFPs 2012
Other Russia
18%
RFPs 2013
Other Russia
15%
RFPs 2014 (on 09Jun)
Other Russia
23%
Source: KCR’s CRM database (Salesforce.com)
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

8. Association of clinical trials
organizations (ACTO) and its role
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ACTO’s primary objectives are:
Maintaining constructive dialogue with regulatory authorities and
general public aimed at the development of stable local legislative
basis for the clinical trials conduct harmonized with the respective
worldwide standards;
Promoting an ethical business model;
Ensuring a proper and effective balance between the interests of
parties involved in clinical trials including the patients, the medical
community, and the general public and governmental agencies.
Association of Clinical Trials Organizations (ACTO) –
non-commercial organization of the companies/ legal
entities and clinical research community engaged in
clinical trials in Russia (http://acto-russia.org).
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

9. Regulatory timelines: law vs reality
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Timeframes For Issuing Approvals, year 2013
Timeframes
According
Legislation
(Business /
Calendar
Days)
Average
Timeframe
s
(Calendar
Days)
Minimum
Timeframe
s
(Calendar
Days)
Maximum
Timeframe
s
(Calendar
Days)
Sampling
To Conduct Clinical Trials 41/57 87 32 223 177
Timeframes For Issuing Approvals, year 2012
Timeframes
According
Legislation
(Business /
Calendar
Days)
Average
Timeframe
s
(Calendar
Days)
Minimum
Timeframe
s
(Calendar
Days)
Maximum
Timeframe
s
(Calendar
Days)
Sampling
To Conduct Clinical Trials 41/57 116 22 410 199
Source: http://acto-russia.org
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

10. Regulatory approach and timelines by
kcr
Page / 10 Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva
14 calendar days 75-90 calendar days 21 calendar days
IN
TOTAL
110-125
calendar
days
MoH Approval
CEC Expertise
Pharm Expertise
LEC approvals
IMP import approval
& importation
Export approvals
Importation of
materials
Docs
preparation
E-submission
Paper
submission

11. Few Tips for successful
study planning and conduction
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Primary Submission package – what is different?
Local Compulsory Insurance of the life and health of a
patient involved in clinical trials
Contracts with the study sites
External Logistics – advance shipment of IMP and study
materials to Russia (drug labels, CoAs, Proforma invoices,
import approval)
Internal Logistics of IMP and biosamples – distances and
temperatures
* Source: Russian Federal Law № 61-FZ “On Circulation of Medicines” (with amendments)
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

12. Getting marketing authorization (1)
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According to current legislation* the process of drug
registration should not take more than 210 business days
from the moment of submission of MA Application
This term includes the time necessary for repeated expertise (if needed),
but does not include the time, necessary for the clinical trial conduction
In practice the process of marketing authorization takes
around 1 year
* Source: Russian Federal Law № 61-FZ “On Circulation of Medicines” (with amendments)
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

13. Getting marketing authorization (2)
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Clinical trial + registration
dossier submission
“administrative” expertise of
dossier, its division and sending
for expertise
Clinical trial dossier
(expertise)
Registration dossier
(expertise)
Clinical trial approval
Clinical trial conduction
Clinical trial results
Registration certificate
“Stop-
time”
Kcr seminar / stockholm, 18Jun / nadezhda ivaneeva

14. conclusions
Russia is especially a good place for clinical trials when a big
number of patients is to be recruited in short timelines,
disease is rare, and the drug is planned for marketing in
Russia. Areas to be carefully addressed: regulatory timelines
& logistics of IMP and biosamples, Contracts with sites.
Russia is becoming more popular (based on KCR internal
data, ACTO and clinicaltrials.gov data).
Clinical trial approval and marketing authorization are not
difficult to get in case one accurately follows local
requirements and practices.
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15. QUESTIONS
& ANSWERS
Russia –
Is it an accessible market for
international research and development?
Contact:
Nadezhda Ivaneeva, MA, MBA
General Manager Russia & Kazakhstan, KCR S.A.
Email: Nadezhda.Ivaneeva@kcrcro.com

16. About KCR
KCR is a European Contract Research Organization (CRO) with a dynamic team of nearly
300 professionals operating across 18 countries in Europe as well as the U.S.
With 17 years of experience, more than 350 trials executed, over 30,000 patients recruited
and almost 3,000 sites contracted, KCR is a strategic solutions provider and a reliable
alternative to global CROs, delivering the all-important flexibility.
We provide services on long standing global or local contracts to 12 out of the Top 20
Global Pharma companies, and have been granted by 3 of them with the Preferred
Provider certification.
KCR offers clinical development support via 3 types of professional services:
- Full Service Model for Clinical Development Services (Phase I-IV)
- Functional Service Provider (FSP)
- Post-Marketing Clinical Services
For more information about the KCR offer, please visit www.kcrcro.com or contact us at
info@kcrocro.com.
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