Safeguard to
Clinical Trials in Europe
Maja Conkic, 28 February 2019
Disclaimer
The information within
this presentation is
based on presenter’s
experience and
represents the views of
the presenter.
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Safeguard
Noun
1
a : pass, SAFE-CONDUCT
b : convoy, escort
2
a : a precautionary measure, stipulation, or device
b : a technical contrivance to prevent accident
Verb
safeguarded; safeguarding; safeguards
1 : to provide a safeguard for
2 : to make safe : PROTECT
https://www.merriam-webster.com/dictionary/safeguard
accessed on 27 February 2019
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Europe
Europe is a continent located entirely in
the Northern Hemisphere and mostly in
the Eastern Hemisphere
There are 50 internationally recognized
sovereign countries in Europe and 6
countries with limited recognition
The European Union (EU)
The European Union is a unique economic and political
union between 28 EU countries.
https://en.wikipedia.org/wiki/Europe, accessed on 27 February 2019
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Official Website of the European Union
https://europa.eu/european-union/abouteuropa_en
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The 28 Member Countries of the EU
1. Austria
2. Belgium
3. Bulgaria
4. Croatia
5. Cyprus
6. Czechia
7. Denmark
8. Estonia
9. Finland
10. France
11. Germany
12. Greece
13. Hungary
14. Ireland
15. Italy
16. Latvia
17. Lithuania
18. Luxembourg
19. Malta
20. Netherlands
21. Poland
22. Portugal
23. Romania
24. Slovakia
25. Slovenia
26. Spain
27. Sweden
28. United Kingdom
https://europa.eu/european-union/about-eu/countries_en, accessed on 27 Feb 19
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The European Free Trade Association (EFTA) Countries
1.
Iceland
2.
Liechtenstein
3.
Norway
4.
Switzerland
The European Free Trade Association (EFTA) is the
intergovernmental organisation that operates in parallel with
the European Union (EU), and all four member states participate
in the European Single Market and are part of the Schengen
Area. They are not, however, party to the European Union
Customs Union.
https://en.wikipedia.org/wiki/European_Free_Trade_Association, accessed on 27 Feb 19
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Candidate Countries
The countries in the process of 'transposing' (or integrating)
EU legislation into national law:
1.
Albania
2.
Montenegro
3.
North Macedonia
4.
Serbia
5.
Turkey
https://europa.eu/european-union/about-eu/countries_en, accessed on 27 Feb 19
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Potential Candidates
The countries that do not yet fulfil the requirements for EU
membership:
1.
Bosnia and Herzegovina
2.
Kosovo*
https://europa.eu/european-union/about-eu/countries_en, accessed on 27 Feb 19
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Other European Countries
1. Andorra
2. Armenia
3. Azerbaijan
4. Belarus
5. Georgia
6. Iceland
7. Liechtenstein
8. Moldova
9. Monaco
10. Norway
11. Russia
12. San Marino
13. Switzerland
14. Ukraine
15. Vatican City
https://europa.eu/european-union/about-eu/countries_en, accessed on 27 Feb 19
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The Map
https://europa.eu/european-union/about-eu/countries_en, accessed on 27 Feb 19
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United Kingdom’s Withdrawal from the European
Union ('Brexit')
On 29 March 2017, the United Kingdom (UK) notified the
European Council of its intention to withdraw from the
European Union.
https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-europeanunion-brexit, accessed on 27 February 2019
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The European Union Clinical Trials Register (EU Clinical
Trials Register)
The EU Clinical Trials Register currently displays 34227 clinical trials
with a EudraCT protocol, of which 5549 are clinical trials conducted
with subjects less than 18 years old.
The register also displays information on 18700 older pediatric
trials (in scope of Article 45 of the Paediatric Regulation (EC) No
1901/2006).
The EU Clinical Trials Register contains information on
interventional clinical trials on medicines conducted in the
European Union (EU), or the European Economic Area (EEA)
which started after 1 May 2004.
https://www.clinicaltrialsregister.eu/about.html, accessed on 27 February 2019
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Clinical Trials in European Union
The conduct of clinical trials in the EU is currently governed by
the Clinical Trials Directive 2001/20/EC.
The Directive will be repealed by the Clinical Trials Regulation
EU No 536/2014, upon its application in 2019.
https://ec.europa.eu/health/human-use/clinical-trials_en, accessed on 27 Feb 2019
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Transition from the Clinical Trials Directive to Regulation
Until the Clinical Trials Regulation will become applicable, all clinical
trials performed in the European Union are required to be conducted
in accordance with the Clinical Trials Directive. This Directive will be
repealed on the day of entry into application of the Clinical Trials
Regulation
The Directive will still apply three years from the date of application of
the Regulation to:
- Clinical trials applications submitted before the entry into
application and
- Clinical trials applications submitted within one year after the entry
into application if the sponsor opted for old system
https://ec.europa.eu/health/human-use/clinical-trials_en, accessed on 27 Feb 2019
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The European Medicines Agency (EMA)
https://www.ema.europa.eu, accessed on 27 February 2019
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EMA – What they do
The mission of the European Medicines Agency (EMA) is to foster scientific
excellence in the evaluation and supervision of medicines, for the benefit of
public and animal health in the European Union (EU).
- Facilitate development and access to medicines – The Agency uses a wide
range of regulatory mechanisms to achieve these aims, which are
continuously reviewed and improved.
- Evaluate applications for marketing authorisation – Scientific evaluation of
data
- Monitor the safety of medicines across their lifecycle – Pharmacovigilance
- Provide information to healthcare professionals and patients – The Agency
publishes clear and impartial information about medicines and their
approved uses.
https://www.ema.europa.eu/en/about-us/what-we-do, accessed on 27 Feb 19
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EMA – What they don’t do
• Evaluate the initial marketing authorisation application of
all medicines in the EU
The majority of medicines available in the EU are authorised at national
level
• Evaluate applications for the authorisation of clinical trials
The authorisation of clinical trials occurs at Member State level
• Evaluate medical devices, food supplements and
cosmetics
These devices and substances are evaluated at national level
• Carry out research or develop medicines
Pharmaceutical companies or other medicines developers carry out the
research and development of medicine
https://www.ema.europa.eu/en/about-us/what-we-do, accessed on 27 Feb 19
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EMA – What they don’t do
• Take decisions or have information on the price or
availability of medicines
Decisions are at the level of each Member State in the context of
the national health system of that country.
• Control the advertising of medicines
Primarily conducted on a self-regulatory basis by industry bodies,
supported by the statutory role of the national regulatory authorities
in the Member States
• Control or have information on pharmaceutical
patents
Via national patent offices, or via a centralised process at the
European Patent Office
https://www.ema.europa.eu/en/about-us/what-we-do, accessed on 27 Feb 19
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EMA – What they don’t do
• Develop treatment guidelines
National governments or the health authorities of individual EU Member States
• Provide medical advice
Healthcare professionals
• Develop laws concerning medicines
The European Commission develops EU legislation concerning medicines and
the European Parliament together with the Council of the European Union
adopt it. The European Commission also develops EU policies in the field of
human or veterinary medicines and public health.
• Issue marketing authorisations
The legal decision to grant, suspend or revoke a marketing authorisation for
any medicine falls under the remit of the European Commission for centrally
authorised products, and the national competent authorities of the EU
Member States for nationally authorised products.
https://www.ema.europa.eu/en/about-us/what-we-do, accessed on 27 Feb 19
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National Competent Authorities
The European Medicines Agency works closely with the national
competent authorities of the Member States of the European Union
(EU) and the European Economic Area (EEA) responsible for human
medicines.
The national competent authorities are primarily responsible for the
authorisation of medicines available in the EU that do not pass
though the centralised procedure.
They also supply thousands of European experts who serve as
members of the Agency's scientific committees, working parties or
in assessment teams supporting their members.
https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-memberstates/national-competent-authorities-human, accessed on 27 Feb 19
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The European Medicines Agency (EMA)
https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human, accessed on 27 Feb 19
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The European Medicines Agency (EMA)
https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human, accessed on 27 Feb 19
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The European Medicines Agency (EMA)
https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human, accessed on 27 Feb 19
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The European Medicines Agency (EMA)
https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human, accessed on 27 Feb 19
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EMA Official Announcement on Brexit
One of the consequences of Brexit is that EMA will relocate to
Amsterdam, the Netherlands, where it has to take up its operations
on 30 March 2019 at the latest.
The Agency continues its operations in accordance with the timelines
set by its rules and regulations.
EMA is working on the scenario that the UK will become a third
country as of 30 March 2019. As a consequence, the UK will no longer
be able to engage as (co)-rapporteur for new marketing authorisation
applications for which the centralised procedure would finish after 30
March 2019. This is without prejudice to the outcome of the
withdrawal negotiations.
https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-unionbrexit, accessed on 27 Feb 19
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EMA Official Announcement on Brexit
EMA will leave its premises in London on 1 March 2019.
From 4 to 8 March, the Agency will operate on the basis of extended
teleworking. During this week a small number of staff will be present
in the new building to deal with any emergencies should the need
arise. During the course of the following week (11-15 March) EMA
staff will gradually move into the Spark building.
In April 2019, once the Agency has completed its move to the Spark
building in Amsterdam, the Agency will review which other activities
from the multiannual work plan can be resumed in the second half of
2019.
https://www.ema.europa.eu/en/news/ema-relocation-updates, accessed on 27 Feb 19
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Q & A
.‫תודה על ההקשבה‬
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