Presentation           by Dr. med. Karl-Peter Klein            Dip Pharm Med RCP UK, FFPM RCP UKManaging DirectorAtoZ-CRO ...
How can Europe help to speed up    your drug development           Conditions,Rules and Cost of doing clinical trials in C...
Content• Patients with rare diseases• Availability of motivated patients• Drug naive patients• Motivated investigators• Ve...
How can Europe help to speed up your drug development                 Rare Diseases  Europe can help to speed up recruitme...
How can Europe help to speed up your drug development      Availability of motivated patients  Esp. in Eastern Europe for ...
How can Europe help to speed up your drug development              Drug Naive Patients    In some areas in Europe patients...
How can Europe help to speed up your drug development         Many motivated Investigators       In Europe there are many ...
How can Europe help to speed up your drug development        Very experienced Investigators         In Europe there are ma...
How can Europe help to speed up your drug development                Quality of Data  Most inspection results by the US FD...
How can Europe help to speed up your drug development     The cost for clinical trials is lower in           Europe compar...
How can Europe help to speed up your drug development         Fast Marketing Autorisation    Involvement of study sites in...
How can Europe help to speed up your drug development            Fast Marketing Success    Involvement of study sites in E...
Conditions, Rules of doing clinical trials in Europe      Conditions to start trials in Europe• There is a certain hormoni...
Conditions, Rules of doing clinical trials in                 Europe               CTA Review- Applicaton is validated- 30...
The ICH-GCP compliance, theavailability of subjects, the quality ofinvestigators, the time-reduced and thelow costs are by...
ConclusionConducting trials in Europe may help to- accelerate development- reduce costs- support international registratio...
Thank you            18
How Can Europe Help to Speed Up Your Drug Development - Karl Peter Klein, AtoZ-CRO GmbH
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How Can Europe Help to Speed Up Your Drug Development - Karl Peter Klein, AtoZ-CRO GmbH

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Karl Peter Klein, AtoZ-CRO GmbH - Speaker at the marcus evans Evolution Summit 2012, held in Wheeling, IL, April 30 - May 2, 2012, delivered his presentation entitled How Can Europe Help to Speed Up Your Drug Development

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How Can Europe Help to Speed Up Your Drug Development - Karl Peter Klein, AtoZ-CRO GmbH

  1. 1. Presentation by Dr. med. Karl-Peter Klein Dip Pharm Med RCP UK, FFPM RCP UKManaging DirectorAtoZ-CRO GmbHClinical ResearchLeyenhaus 29, 51491 Overath/Germanye-mail: kp.klein@atoz-cro.dewww.atoz-cro.de Presented at the Marcus Evans Evolution Summit Conference Westin Chicago North Shore - Wheeling, IL, USA on May 1, 2012 2012‐05‐01 1
  2. 2. How can Europe help to speed up your drug development Conditions,Rules and Cost of doing clinical trials in Central and Eastern Europe 2
  3. 3. Content• Patients with rare diseases• Availability of motivated patients• Drug naive patients• Motivated investigators• Very experienced investigators• Quality of data• Fast Marketing Autorisation• Fast Marketing Success• Cost for clinical trials is lower in Europe• Conditions to start trials in Europe 4
  4. 4. How can Europe help to speed up your drug development Rare Diseases Europe can help to speed up recruitment by having access to greater patient populations in rare diseases 5
  5. 5. How can Europe help to speed up your drug development Availability of motivated patients Esp. in Eastern Europe for certain patients there is a lack of medical treatment; this causes a high motivation to enter clinical trials Patients travel long distances to meet the investigators Patients are highly motivated and show a high compliance 6
  6. 6. How can Europe help to speed up your drug development Drug Naive Patients In some areas in Europe patients are not overloaded with other drugs as they are in theUS or Germany, this means drug effects may be seen clearer and earlier, this is of incrediblevalue and may speed up development process or allow earlier decisions 7
  7. 7. How can Europe help to speed up your drug development Many motivated Investigators In Europe there are many highly motivated investigators and trial sites 8
  8. 8. How can Europe help to speed up your drug development Very experienced Investigators In Europe there are many very experienced investigators and trial sites 9
  9. 9. How can Europe help to speed up your drug development Quality of Data Most inspection results by the US FDA in Europe have shown a good quality of data Based on experience of inspectors from the US FDA, the number of findings in Europe are about the same as in the US 10
  10. 10. How can Europe help to speed up your drug development The cost for clinical trials is lower in Europe compared to US In Western Europe cost is about 80% In Eastern Europe about 50% of the cost in the US 11
  11. 11. How can Europe help to speed up your drug development Fast Marketing Autorisation Involvement of study sites in Europe in early drug development supports the later appoval process in Europe 12
  12. 12. How can Europe help to speed up your drug development Fast Marketing Success Involvement of study sites in Europe in the drug development later on supports the marketing of these drugs 13
  13. 13. Conditions, Rules of doing clinical trials in Europe Conditions to start trials in Europe• There is a certain hormonization in the EU countries• Offices in Europe or a legal representative• Qualified Person for PV within the EU• Approval of the Clinical Trial Application by the Competent Authority• Positive vote by the Ethics Committee (EC) 14
  14. 14. Conditions, Rules of doing clinical trials in Europe CTA Review- Applicaton is validated- 30 (or 60) days review- Deficiency letter may be issued- After the response an additonalreview is completed 15
  15. 15. The ICH-GCP compliance, theavailability of subjects, the quality ofinvestigators, the time-reduced and thelow costs are by far the importantcriteria for choosing Eastern Europecountries to conduct clinical trials. 16
  16. 16. ConclusionConducting trials in Europe may help to- accelerate development- reduce costs- support international registration- support international marketing 17
  17. 17. Thank you 18

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