This document summarizes the clinical research potential and infrastructure in Turkey. It notes that Turkey has 94 universities, 59 medical schools, 1190 hospitals and over 95,000 medical doctors. The number of clinical trials conducted in Turkey has increased significantly from 1997 to 2006. Turkey offers advantages for clinical trials such as a large and growing population, well-established medical and regulatory systems, and lower costs than many European countries. Using a local CRO can help reduce costs and save time when conducting clinical trials in Turkey by leveraging local knowledge and relationships.
Assessing the European Commission's Proposal to Revise the Clinical Trial Dir...Cognizant
- The European Commission proposed revising the 2001 Clinical Trials Directive to simplify regulatory requirements for clinical trials and improve harmonization across EU states.
- The current directive led to high costs, administrative burdens, and delays in launching clinical trials due to differing implementation across states.
- A six-step process outlines how life sciences organizations can prepare for the upcoming changes, including forming a core team, assessing impacts, piloting changes, and continuously monitoring compliance with the new regulation.
The document provides an outline for a presentation on stress management. It covers three main parts: general awareness of stress, stress at work, and self-help. For part one, it defines stress and outlines types of stressors, the body's stress response, symptoms of stress, and costs of stress. Part two discusses factors that can cause work stress and changing work patterns. Part three recommends identifying stress causes, maintaining balance, and using techniques like positive thinking, changing behaviors, and lifestyle changes to manage stress.
This document provides an overview of clinical trials in Turkey. It discusses the history and evolution of regulations governing clinical trials from the 1920s to present day. Key events include the first regulations in 1928, formation of ethics committees in 1993, and adoption of ICH-GCP guidelines in 1995. The infrastructure for clinical trials in Turkey has grown significantly in recent decades with over 100 ethics committees and several phase I centers. Inspections by regulatory authorities like the FDA and EMA have increased transparency. Current regulations aim to protect participants and uphold ethical standards in research.
This document provides 26 tips for stress management from A to Z. Some key tips include taking daily breaks of at least 30 minutes, regular exercise, eating a healthy diet, getting enough sleep, limiting stimulants like alcohol, and making time for hobbies and relationships to relax and relieve stress. The overall message is that practicing these stress management techniques can help people lead a less stressful and more enjoyable life.
This document summarizes a two-day training on stress management for GDMOs. The training consisted of four sessions led by different speakers and covered topics such as understanding stress, causes and factors that enhance stress, situations of stress in the government sector, and stress management techniques. Key points included defining stress as tension, identifying predestined events and focusing on one's work as ways to manage stress according to the Bhagavad Gita. Stress management techniques discussed letting go of negative thoughts, meditating daily, and writing down and discarding negative thoughts each day.
This document discusses stress management and relaxation techniques. It begins by explaining what stress is and how it affects the body, noting both good stress (eustress) and bad stress (distress). Prolonged stress can lead to insomnia, digestive issues, ulcers, women's health problems, low immunity, chronic pain, and exhaustion. The document then discusses common causes of stress like social factors, thoughts and perceptions, environmental factors, and physiological factors. It concludes by recommending managing stress through developing a balanced lifestyle, changing causes of stress, and using relaxation techniques.
Assessing the European Commission's Proposal to Revise the Clinical Trial Dir...Cognizant
- The European Commission proposed revising the 2001 Clinical Trials Directive to simplify regulatory requirements for clinical trials and improve harmonization across EU states.
- The current directive led to high costs, administrative burdens, and delays in launching clinical trials due to differing implementation across states.
- A six-step process outlines how life sciences organizations can prepare for the upcoming changes, including forming a core team, assessing impacts, piloting changes, and continuously monitoring compliance with the new regulation.
The document provides an outline for a presentation on stress management. It covers three main parts: general awareness of stress, stress at work, and self-help. For part one, it defines stress and outlines types of stressors, the body's stress response, symptoms of stress, and costs of stress. Part two discusses factors that can cause work stress and changing work patterns. Part three recommends identifying stress causes, maintaining balance, and using techniques like positive thinking, changing behaviors, and lifestyle changes to manage stress.
This document provides an overview of clinical trials in Turkey. It discusses the history and evolution of regulations governing clinical trials from the 1920s to present day. Key events include the first regulations in 1928, formation of ethics committees in 1993, and adoption of ICH-GCP guidelines in 1995. The infrastructure for clinical trials in Turkey has grown significantly in recent decades with over 100 ethics committees and several phase I centers. Inspections by regulatory authorities like the FDA and EMA have increased transparency. Current regulations aim to protect participants and uphold ethical standards in research.
This document provides 26 tips for stress management from A to Z. Some key tips include taking daily breaks of at least 30 minutes, regular exercise, eating a healthy diet, getting enough sleep, limiting stimulants like alcohol, and making time for hobbies and relationships to relax and relieve stress. The overall message is that practicing these stress management techniques can help people lead a less stressful and more enjoyable life.
This document summarizes a two-day training on stress management for GDMOs. The training consisted of four sessions led by different speakers and covered topics such as understanding stress, causes and factors that enhance stress, situations of stress in the government sector, and stress management techniques. Key points included defining stress as tension, identifying predestined events and focusing on one's work as ways to manage stress according to the Bhagavad Gita. Stress management techniques discussed letting go of negative thoughts, meditating daily, and writing down and discarding negative thoughts each day.
This document discusses stress management and relaxation techniques. It begins by explaining what stress is and how it affects the body, noting both good stress (eustress) and bad stress (distress). Prolonged stress can lead to insomnia, digestive issues, ulcers, women's health problems, low immunity, chronic pain, and exhaustion. The document then discusses common causes of stress like social factors, thoughts and perceptions, environmental factors, and physiological factors. It concludes by recommending managing stress through developing a balanced lifestyle, changing causes of stress, and using relaxation techniques.
Life & health Sciences Horizon Panel ReportEuroBioForum
The document summarizes a report by the Life & Health Sciences Horizon Panel on opportunities in Northern Ireland's growing life and health sciences sector. Key points include:
- The sector is an important part of the Northern Ireland economy, with over 60 companies employing 4,000 people and £310 million in combined turnover.
- Significant public and private investment has supported research infrastructure and collaboration between industry and academia.
- Globally, demand is rising for effective medicines and healthcare as populations age and diseases change, creating opportunities for growth. The report makes strategic recommendations to maximize economic returns for Northern Ireland.
The document discusses India's growing attractiveness as a destination for clinical trials. It notes that India has a large patient pool, low costs, and a growing clinical research industry. Regulatory reforms have made the environment more favorable and increased India's competitiveness. The number of clinical trials and participating organizations in India has increased significantly in recent years. However, the regulatory approval process can still be improved by establishing timelines and a single window clearance system. Overall, India aims to become a premier global destination for clinical research.
The document summarizes the process for obtaining ethical and regulatory approval for clinical trials in Turkey. Key points include:
1) Applications must be approved by a research ethics committee and then submitted to the Ministry of Health for regulatory approval.
2) For multi-site trials, approval is obtained from the ethics committee where the coordinating center is located, with notifications to other site committees.
3) Timelines for ethics committee review are 30 days, while regulatory review is 30-60 days depending on the type of trial. Substantial amendments require additional approvals.
Xylem Clinical Research Pvt. Ltd. is an Indian Site Management Organization (SMO) that provides support for clinical trials from Phase I-IV. It aims to facilitate smooth execution of trials through services like SMO support, site coordination, regulatory writing, and ensuring sites are audit-ready. Xylem has experience managing sites in diseases like oncology, infectious diseases, and more. It has a team with over 50 years of combined clinical research experience to help sponsors and CROs conduct trials in India on time and to high quality standards.
This document provides guidance for implementing the Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) in the African region. It describes the background and need for the initiative due to weaknesses in public health laboratory systems. The purpose is to guide countries in strengthening laboratory quality management systems using the SLIPTA approach. Key elements covered include the origins of SLIPTA, governance structure, the audit process, criteria for enrollment, evaluation approach using a checklist, process for recognition of improvements, and operational procedures. The definitions section clarifies important terms related to standards, certification, accreditation and related oversight bodies.
Osong Bio Technopolis is being developed as a world-class innovative bio cluster in Korea to drive growth in the bio health and medical industry. The cluster will focus on interdisciplinary cooperation across industries, research institutions, universities and government agencies located on its 4,633,000 square meter site. It aims to become a global leader in the bio industry through an integrated system of R&D, clinical trials, manufacturing, and commercialization. Considerations for its success include attracting qualified members, establishing partnership-based cooperation, developing integrated systems, and connecting to global networks to realize its vision of a next-generation bio cluster.
The Business Fame Magazine is honored to present “The Most Prominent Healthcare Solution Providers In 2021” which are adapting novel technologies to meet and exceed the health care standard.
The document describes Hungary's legal environment and policies around rare diseases. It outlines the structure of Hungary's Rare Disease Centre established in 2008 to coordinate rare disease research and services. It discusses genetic testing availability, newborn screening programs, plans to reorganize genetic services, and the empowerment of patient organizations. Conferences have been held on multidisciplinary rare disease care. Hungary aims to improve rare disease healthcare through centralized expertise and reference centers.
This document summarizes the current regulatory challenges for conducting clinical trials in India. It outlines the evolution of India's clinical trial regulatory framework over time in response to incidents of malpractice. Key recommendations from an expert committee include accrediting clinical sites and investigators, establishing expert review committees, and providing compensation for injuries from trials. Regulatory actions by Indian authorities aim to implement these recommendations. The pharmaceutical industry desires further clarity on issues like liability and access to drugs post-trials. Overall improvements are expected in areas like accreditation, compensation policies, and transparency of the regulatory system.
Code of practice for clinical biochemistry chemical pathologistsVnhDng7
The document provides guidelines for clinical biochemists and clinical biochemistry services. It discusses management of services, staffing and workload, and safety. Key points include that clinical biochemists should take on management roles and ensure high quality services. Staffing levels should be adequate for workload. Safety is a joint responsibility and periodic inspections should be conducted. The guidelines are intended to help provide effective, reliable and safe pathology services.
The EFGCP Report For Clinical Research Projects in TurkeySerkan Kaçar
The document summarizes Turkey's process for obtaining ethical and regulatory approval for clinical trials. It involves sequential approval from an ethics committee and then the Ministry of Health. For multi-site trials, approval is first obtained from the ethics committee where the coordinating center is located, then notifications are made to other site committees. Fees are paid to the ethics committee or Ministry of Health depending on the trial phase. Responsibility for submitting the approval application depends on whether there is a sponsor or principal investigator involved. A single opinion for multi-site trials is achieved by first obtaining ethics committee approval, then notifying other site committees and applying to the Ministry of Health for final authorization to proceed.
Beyond EHR - Achieving Operational Efficiency Callum Bir
Callum Bir
IBC Asia 3rd Asia EHR Conference in held in Singapore November 2011
Callum chaired the workshop for the day with guests speakers from Singapore MOHH, HL7, etc.
This PPT will help you to know economical benefit of video conferencing in different sector. It is on educational level. It will not work as a professional level presentation. this ppt required more facts and figure to actually need that data. MBA, BMS, or any educational level presentation will get much more data from it, This will be sufficient for student level presentation
Turkey is becoming a popular place for clinical trials due to its well-established healthcare system, good clinical trials infrastructure, high quality of data, good and predictable access to patients, transperent regulatory environment. Smooth Drug Development operated in Turkey and provides full service clinical trials.
For more information, please visit https://smoothdd.com/en/company/geography/smooth-drug-development-in-turkey/
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Kenya Pharmaceutical Regulatory Overview and Opportunitiestoroiticham
The document summarizes Kenya's pharmaceutical regulatory system. It discusses the Pharmacy and Poisons Board, which regulates medical products and personnel to ensure safety, quality and efficacy. The Board oversees the registration and listing of medical products, regulation of facilities and training programs, and conducts inspections. The market for pharmaceuticals in Kenya is growing and imports meet over 60% of demand. There are opportunities for manufacturers to set up operations in Kenya and benefit from incentives for production of essential medicines.
Destination Kenya_ A new horizon for Conducting Clinical Research - Clinical ...Gaurav Puppalwar
Kenya is emerging as a promising location for clinical research in Africa due to its growing healthcare infrastructure, economic development, educated population, and high disease burden. While Kenya offers lower costs and a treatment-naïve population, barriers include bureaucratic approval processes, limited trained researchers, and concerns about corruption. However, partnering with organizations like KEMRI can help foreign sponsors navigate the system and conduct large, multi-site trials. Overall, Kenya has strong potential to become a clinical research hub if companies, researchers, and the government continue working to address challenges and maintain high ethical standards.
The document provides an overview of the life sciences sector in British Columbia including:
- The life sciences sector contributes $14.4 billion to BC's GDP and employs almost 180,000 people.
- The sector is growing but faces challenges in access to capital, talent, and coordination of government initiatives.
- Most life sciences companies in BC are small, suggesting room for growth through funding, partnerships, or acquisitions.
Ethiopia: Governing for Quality Improvement in the Context of UHCHFG Project
The government of Ethiopia launched the Health Sector Development Program (HSDP) in the 1990s. During the 2010 reform of the health sector, the Drug Administration and Control Agency was re-established to focus on regulating drugs and food, and expanded their scope by including the regulation of health facilities and personnel. They changed their name to the Ethiopian Food, Medicine and Healthcare Administration and Control Authority, and developed a list of minimum health facility requirements, regulating both public and private health facilities.
The WHO recognizes quality laboratory services as key to improving global health. In Ethiopia, most public health laboratories previously provided suboptimal services without quality management systems. Now, through leadership of the FMOH and partners, laboratories are beginning to implement quality standards. Specifically, I-TECH Ethiopia is supporting 10 laboratories in Amhara, Tigray, and Afar regions to achieve WHO-AFRO accreditation within 2 years using a step-wise approach. This involves systematic quality improvements evaluated annually to earn 1-5 star ratings and ultimately international accreditation. Strengthening laboratory services will support Ethiopia's health system goals and achievement of health outcomes.
Life & health Sciences Horizon Panel ReportEuroBioForum
The document summarizes a report by the Life & Health Sciences Horizon Panel on opportunities in Northern Ireland's growing life and health sciences sector. Key points include:
- The sector is an important part of the Northern Ireland economy, with over 60 companies employing 4,000 people and £310 million in combined turnover.
- Significant public and private investment has supported research infrastructure and collaboration between industry and academia.
- Globally, demand is rising for effective medicines and healthcare as populations age and diseases change, creating opportunities for growth. The report makes strategic recommendations to maximize economic returns for Northern Ireland.
The document discusses India's growing attractiveness as a destination for clinical trials. It notes that India has a large patient pool, low costs, and a growing clinical research industry. Regulatory reforms have made the environment more favorable and increased India's competitiveness. The number of clinical trials and participating organizations in India has increased significantly in recent years. However, the regulatory approval process can still be improved by establishing timelines and a single window clearance system. Overall, India aims to become a premier global destination for clinical research.
The document summarizes the process for obtaining ethical and regulatory approval for clinical trials in Turkey. Key points include:
1) Applications must be approved by a research ethics committee and then submitted to the Ministry of Health for regulatory approval.
2) For multi-site trials, approval is obtained from the ethics committee where the coordinating center is located, with notifications to other site committees.
3) Timelines for ethics committee review are 30 days, while regulatory review is 30-60 days depending on the type of trial. Substantial amendments require additional approvals.
Xylem Clinical Research Pvt. Ltd. is an Indian Site Management Organization (SMO) that provides support for clinical trials from Phase I-IV. It aims to facilitate smooth execution of trials through services like SMO support, site coordination, regulatory writing, and ensuring sites are audit-ready. Xylem has experience managing sites in diseases like oncology, infectious diseases, and more. It has a team with over 50 years of combined clinical research experience to help sponsors and CROs conduct trials in India on time and to high quality standards.
This document provides guidance for implementing the Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) in the African region. It describes the background and need for the initiative due to weaknesses in public health laboratory systems. The purpose is to guide countries in strengthening laboratory quality management systems using the SLIPTA approach. Key elements covered include the origins of SLIPTA, governance structure, the audit process, criteria for enrollment, evaluation approach using a checklist, process for recognition of improvements, and operational procedures. The definitions section clarifies important terms related to standards, certification, accreditation and related oversight bodies.
Osong Bio Technopolis is being developed as a world-class innovative bio cluster in Korea to drive growth in the bio health and medical industry. The cluster will focus on interdisciplinary cooperation across industries, research institutions, universities and government agencies located on its 4,633,000 square meter site. It aims to become a global leader in the bio industry through an integrated system of R&D, clinical trials, manufacturing, and commercialization. Considerations for its success include attracting qualified members, establishing partnership-based cooperation, developing integrated systems, and connecting to global networks to realize its vision of a next-generation bio cluster.
The Business Fame Magazine is honored to present “The Most Prominent Healthcare Solution Providers In 2021” which are adapting novel technologies to meet and exceed the health care standard.
The document describes Hungary's legal environment and policies around rare diseases. It outlines the structure of Hungary's Rare Disease Centre established in 2008 to coordinate rare disease research and services. It discusses genetic testing availability, newborn screening programs, plans to reorganize genetic services, and the empowerment of patient organizations. Conferences have been held on multidisciplinary rare disease care. Hungary aims to improve rare disease healthcare through centralized expertise and reference centers.
This document summarizes the current regulatory challenges for conducting clinical trials in India. It outlines the evolution of India's clinical trial regulatory framework over time in response to incidents of malpractice. Key recommendations from an expert committee include accrediting clinical sites and investigators, establishing expert review committees, and providing compensation for injuries from trials. Regulatory actions by Indian authorities aim to implement these recommendations. The pharmaceutical industry desires further clarity on issues like liability and access to drugs post-trials. Overall improvements are expected in areas like accreditation, compensation policies, and transparency of the regulatory system.
Code of practice for clinical biochemistry chemical pathologistsVnhDng7
The document provides guidelines for clinical biochemists and clinical biochemistry services. It discusses management of services, staffing and workload, and safety. Key points include that clinical biochemists should take on management roles and ensure high quality services. Staffing levels should be adequate for workload. Safety is a joint responsibility and periodic inspections should be conducted. The guidelines are intended to help provide effective, reliable and safe pathology services.
The EFGCP Report For Clinical Research Projects in TurkeySerkan Kaçar
The document summarizes Turkey's process for obtaining ethical and regulatory approval for clinical trials. It involves sequential approval from an ethics committee and then the Ministry of Health. For multi-site trials, approval is first obtained from the ethics committee where the coordinating center is located, then notifications are made to other site committees. Fees are paid to the ethics committee or Ministry of Health depending on the trial phase. Responsibility for submitting the approval application depends on whether there is a sponsor or principal investigator involved. A single opinion for multi-site trials is achieved by first obtaining ethics committee approval, then notifying other site committees and applying to the Ministry of Health for final authorization to proceed.
Beyond EHR - Achieving Operational Efficiency Callum Bir
Callum Bir
IBC Asia 3rd Asia EHR Conference in held in Singapore November 2011
Callum chaired the workshop for the day with guests speakers from Singapore MOHH, HL7, etc.
This PPT will help you to know economical benefit of video conferencing in different sector. It is on educational level. It will not work as a professional level presentation. this ppt required more facts and figure to actually need that data. MBA, BMS, or any educational level presentation will get much more data from it, This will be sufficient for student level presentation
Turkey is becoming a popular place for clinical trials due to its well-established healthcare system, good clinical trials infrastructure, high quality of data, good and predictable access to patients, transperent regulatory environment. Smooth Drug Development operated in Turkey and provides full service clinical trials.
For more information, please visit https://smoothdd.com/en/company/geography/smooth-drug-development-in-turkey/
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Kenya Pharmaceutical Regulatory Overview and Opportunitiestoroiticham
The document summarizes Kenya's pharmaceutical regulatory system. It discusses the Pharmacy and Poisons Board, which regulates medical products and personnel to ensure safety, quality and efficacy. The Board oversees the registration and listing of medical products, regulation of facilities and training programs, and conducts inspections. The market for pharmaceuticals in Kenya is growing and imports meet over 60% of demand. There are opportunities for manufacturers to set up operations in Kenya and benefit from incentives for production of essential medicines.
Destination Kenya_ A new horizon for Conducting Clinical Research - Clinical ...Gaurav Puppalwar
Kenya is emerging as a promising location for clinical research in Africa due to its growing healthcare infrastructure, economic development, educated population, and high disease burden. While Kenya offers lower costs and a treatment-naïve population, barriers include bureaucratic approval processes, limited trained researchers, and concerns about corruption. However, partnering with organizations like KEMRI can help foreign sponsors navigate the system and conduct large, multi-site trials. Overall, Kenya has strong potential to become a clinical research hub if companies, researchers, and the government continue working to address challenges and maintain high ethical standards.
The document provides an overview of the life sciences sector in British Columbia including:
- The life sciences sector contributes $14.4 billion to BC's GDP and employs almost 180,000 people.
- The sector is growing but faces challenges in access to capital, talent, and coordination of government initiatives.
- Most life sciences companies in BC are small, suggesting room for growth through funding, partnerships, or acquisitions.
Ethiopia: Governing for Quality Improvement in the Context of UHCHFG Project
The government of Ethiopia launched the Health Sector Development Program (HSDP) in the 1990s. During the 2010 reform of the health sector, the Drug Administration and Control Agency was re-established to focus on regulating drugs and food, and expanded their scope by including the regulation of health facilities and personnel. They changed their name to the Ethiopian Food, Medicine and Healthcare Administration and Control Authority, and developed a list of minimum health facility requirements, regulating both public and private health facilities.
The WHO recognizes quality laboratory services as key to improving global health. In Ethiopia, most public health laboratories previously provided suboptimal services without quality management systems. Now, through leadership of the FMOH and partners, laboratories are beginning to implement quality standards. Specifically, I-TECH Ethiopia is supporting 10 laboratories in Amhara, Tigray, and Afar regions to achieve WHO-AFRO accreditation within 2 years using a step-wise approach. This involves systematic quality improvements evaluated annually to earn 1-5 star ratings and ultimately international accreditation. Strengthening laboratory services will support Ethiopia's health system goals and achievement of health outcomes.
2. Turkey: The Potential for Clinical Trials
The potential for conducting The goal is to have 40,000
Clinical trials in Turkey is people working in this area by
enormous. There are 94 the year 2010. The annual
universities, 59 medical schools, budget reserved for clinical
1190 hospitals, 200,000 hospital trials by the pharmaceutical
beds. 95,100 medical doctors are in companies in Turkey was 27.5
practice and 46% are specialized. If million dollars in 2005.
we look at the number and
distribution of Research and
Development personnel, they can
be broken down as follows:
37% technological sciences,
19% maths, physics, life science
14% medical sciences,
11% agriculture
3. The Increasing Interest
In the last ten years, the
This increase has
number of physicians who
necessitated the
wish to conduct a clinical
pharmaceutical companies to
trial has increased, mainly
outsource their load. At
due to an increase in the
present, there are around 15
awareness of the
CROs in Turkey, working
importance of clinical trials
mainly for the pharmaceutical
and the increasing interest
companies.
of pharmaceutical
companies.
5. Clinical Research- Important Advantages
Growing Population
With a expanding population of 74
million and a developing
infrastructure, Turkey is a promising
plateau for clinical research. The EU
integration process will provide a
better future for clinical drug trials
and the GCP education programs will
increase the number of qualified
clinical researchers and ethical
committee members.
Rate of Population Growth between the
years 1961 - 2001
6. Untapped market
During the last 25 years the liberal economic policies
of several governments have opened the Turkish
markets to foreign investors and the clinical research
is no exception. The current estimate that drug trials
comprise around 10 million dollars in activity for
Turkey annually is still considered to be quite low
compared to many European countries, but the
gradually increasing number of trials is expected to
have a significant impact in medical, scientific and
economic progress.
Well established medical and regulatory infrastructure
Important advantages that Turkey offers are the
presence of well- equipped and high level university
and state hospitals, well-trained specialized clinicians:
lower costs associated with ethical reviews, regulatory
approvals and investigator compensation, and a good
success rate for patient recruitment.
7. Phase Clinical Trials in
Phase Clinical Trials in
Turkey 1997-2006
Turkey 1997-2006
250
250
200 Phase I
200 Phase I
150 Phase II
150 Phase II
Phase III
100 Phase III
100 Phase IV
Phase IV
50 Total
50 Total
0
0
7
98 8
9
00 0
1
02 2
2003 3
04 4
2005 5
06 6
1919 9
19 9
1919 9
20 0
2020 0
20 0
2020 0
20 0
2020 0
20 0
1997
2909
2001
8. Approval of
Approval of
Preparation of Local
Preparation of Local
Local Dossier Ethics
Local Dossier Ethics
Committees
Committees
Submission to
Submission to Submission to
Submission to Ministry of Submission for
Local Ethic Ministry of Submission for
Local Ethic Health Import License
Committee Health Import License
Committee
Approval by Ministry of
Approval by Ministry of
Health
Health
Timelines for study approvals
Timelines for study approvals
1 1 2
2 weeks 2 weeks week week 2 months days
9. The Advantage of a Local CRO partner
Local CROs, and international organizations with a strong local presence, can
provide an answer to the challenges of emerging markets.
As the clinical trial markets in these countries grow, the number of CROs with local
knowledge is also increasing.
A local CRO can understand the Turkish
A local CRO can understand the Turkish
market, how ititfunctions and the most
market, how functions and the most
expedient ways to solve problems.
expedient ways to solve problems.
A local CRO can understand how to reduce costs and
A local CRO can understand how to reduce costs and
save time when conducting aastudy in Turkey
save time when conducting study in Turkey
10. “While many U.S- and European-based pharma / biotech
companies are looking for novel sites for clinical trials,
Turkey, with her increasing number of medical schools
and highly specialized trained clinicians and scientists, is
becoming even more attractive as an investment and
professional site for clinical trials.”
Clinical Scientific Research Potentials
in Turkey 2007