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Digital consent: Clinical trials to require patient nod on camera in India..



To safeguard the interests of patients participating in clinical trials, their informed consent will soon have to be audio-visually recorded in India.


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World Clinical Trials Day...



20th of May is celebrated as the World Clinical Trials Day. May 20 is the day the first clinical trial was initiated by Dr. James Lind in May 20, 1747.


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Biosimilar consensus report form EC..

European Commission revealed the Biosimilar Consensus report. The report seems to be a reference document for the future in Europe on biosimilars.


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Clinical Research Association celebrates Mother's Day..



A man loves his sweetheart the most, his wife the best, but his mother the longest (Irish Proverb)

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English version of the new bylaw on Clinical Research..


English version of the new bylaw on Clinical Research is available now.


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2023 Strategy Report of Association of Research Based Pharmaceutical Companies (AIFD)..



AIFD released ''Turkey's Pharmaceutical Sector Vision 2013 Report''


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British Medical Journal initiated Pharmacovigilance education..



In collaboration with UK Medicines and Healthcare products Regulatory Agency (MHRA), BMJ started a learning module titled ''Pharmacovigilance – identifying and reporting adverse drug reactions''.

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New amendment of the Clinical Research Bylaw is effective..


Major changes are:
- Simultaneous application to both Ethical Committee and MoH
- Submission to and approval of any ethical committee regardless of the Principal Investigator institution.

Clinical research in private hospitals is still not allowed.



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Unreported Side Effects of Drugs Are Found Using Internet Search Data...

Using data drawn from queries entered into Google, Microsoft and Yahoo search engines, scientists at Microsoft, Stanford and Columbia University have for the first time been able to detect evidence of unreported prescription drug side effects before they were found by the Food and Drug Administration’s warning system.


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Time required to publication of clinical trials..

According to an article from JAMA, it takes 2 years for a clinical trial to be published in a journal. 25-50% of the clinical trials never get the chance to be published.


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Turkey data on Clinicaltrials.gov...

Latest data on clinical trials in Turkey from clinicaltrials.gov.


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Turkey will not participate in DIA Amsterdam 2013...

After the decision of Istanbul being the venue of DIA Europe 2014, DIA Board changed their mind and moved the location to Vienna.
In reaction to that, MoH Turkey declined to participate in DIA 2013 Amsterdam, and this decision involves all the speakers and attendants from MoH Turkey.    
You can find the letter sent to DIA form our Society that supports the decision of MOH.


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FDA Publishes the new edition of Orange Book..



The FDA has published its 33rd edition of the Orange Book. The book is widely used in the regulatory community for identifying which drug products are substitutable for one another. The book contains all drug products that are approved or have not been withdrawn for reasons of safety or efficacy with the exception of products marketed before 1938


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Top 5 drugs in 2012 Q4..



Top 5 drugs in Q4 2012 according to Drugs.com.


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FDA Drug approvals in 2012..



FDA approved 39 new drugs last year, the highest in the last 15 years according to Nature Drug Discovery..


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The Harvard Medical School Global Clinical Scholars Research Training Program (GCSRT)...

The Harvard Medical School initiated Global Clinical Scholars Research Training Program (GCSRT)..


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VSCR closes down its business...


Vienna School of Research stopped all operations as of January 11th, 2013 due to lack of financial support.


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Four members of the Cabinet revised...

4 members of the cabinet changed including the Ministry of Health; Dr. Recep Akdağ..

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EC Releases New Good Manufacturing Practices Guidelines...


Following chapters have been revised:
Premises and Equipment, 
Production, 
Quality Control, 
Complaints , Quality Defects and Product Recalls


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New EMA guideline on the investigation of drug interactions..


This guideline outlines a comprehensive, systematic and mechanistic approach to the evaluation of the interaction potential of a drug during its development and offers guidance to ensure that the prescriber receives clear information on the interaction potential as well as practical recommendations on how the interactions should be managed during clinical use.



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FDA offices in India



FDA now has 2 offices in New Delhi and Mumbai. India is the second largest drug exporter and the seventh largest food exporter to the U.S.




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FDA issues Three Critical Medical Device Guidance Documents...

The guidelines are:

eCopy Program for Medical Device Submissions
Refuse to Accept Policy for 510(k)s
Acceptance and Filing Review for Premarket Approval Applications (PMAs)



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Clinical Trials vs Clinical Practice..

As clinical trials are performed under specific conditions, there is always a debate on whether the results of a clinical trial reflects daily practice. A modest reply to that question comes from an article published in JAMA.


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Happy New Year..



Wish you a happy new year and merry Xmas..

Clinical Research Association..


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Partnerships in Clinical Trials Russia-CIS & MENA-Turkey...

'' Partnerships in Clinical Trials Russia-CIS & MENA-Turkey'' meeting will be held in Renaissance Polat Istanbul Hotel, Istanbul on 22-23 May 2013. There will be additional benefits for our website members.



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Smoking and Clinical Research..

 
FDA required the manufacturer of the smoking cessation drug varenicline to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug, and  is informing the public about the results of a meta-analysis that compared patients who received the smoking cessation drug varenicline to patients who received a placebo.


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2012 Performance Analysis of the Global Medical Technology Industry: Ernst & Young Report..

In this report, medical technology (medtech) companies are defined as companies that primarily design and manufacture medical technology equipment and supplies and are headquartered within the United States or Europe. For the purposes of this report, we have placed Israel’s data and analysis within the European market, and any grouping of the US and Europe has been referred to as “global.”



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FDA Draft Guidance on IRBs.....


A new draft guidance published by the US Food and Drug Administration (FDA) aims to clarify the responsibilities of institutional review boards (IRBs) in the oversight of investigators, research sites and investigational authority of sponsors.


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The International Compilation of Human Research Standards avaialable..

The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations. Many of the listings embed hyperlinks to the source document.


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Nine Italian cardiologists arrested for fraud and misconduct...

Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. Several news reports mentioned that stents and angioplasty balloons were involved.


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The latest analysis of clinicaltrials.gov..


Clinical trials in Turkey according to clinicaltrials.gov..

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New information on the regulation of clinicaltrials.gov...

Our previous news titled "FDA now in Charge of clinicaltrials.gov" was inaccurate. Read the details..

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FDA now in Charge of clinicaltrials.gov...

Previously regulated by DHHS; clinicaltrials.gov is now in the hands of FDA..


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New EU GMP Chapter 1 published...


The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called "Pharmaceutical Quality System". 


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FDA announced Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications.



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Gaining income from research in Universities?

In USA, Universities Report $1.8-Billion in Earnings on Inventions in 2011.

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ABPI has updated its guidelines on Phase I clinical trials...

The Association of the British Pharmaceutical Industry (ABPI) has updated its guidelines on Phase I clinical trials.

 



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Digital Health Summit Turkey..

Digital Health Summit Turkey will be held in Istanbul on 11-12 September.


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Medical Device Manufacturing Turkey..

Medical Device Manufacturing Turkey meeting will be held in Istanbul on 3-4 October 2012.


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FDA Adopts ICH Guidance on Pharmaceutical Quality..


The US Food and Drug Administration released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan.



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1. National Clinical Research Congress..


1. National Clinical Research Congress will be held in Istanbul by Clinical Research Society. The meeting will take place in Military Museum on 2-4 May 2013.


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European Medicines Agency released all good pharmacovigilance practice modules...


The European Medicines Agency has released all modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.

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EMA finalises first set of guidelines on good pharmacovigilance practices...

European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices.


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European Medicines Agency boosts EU transparency with online publication of suspected side effect reports..

The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www.adrreports.eu

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ESHLSG Guidelines on transparency in clinical research.

The Ethical Standards in Health and Life Sciences Group (ESHLSG) published the principles of transparency in clinical research in a guideline. This is a joint effort of health care professionals and pharmaceutical industry.

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From JAMA: Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

In an article published in the last issue of JAMA, Clinical Trials Registered in ClinicalTrials.gov between 2007-2010 were analyzed.


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From FDA:  Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval..


This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations.

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Off-label prescriptions..

An article in Archieves of Internal Medicine is describing the off-label drug use in Canada. According to the article, the prevalence of off-label use was 11.0%; of the off-label prescriptions, 79.0% lacked strong scientific evidence.


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Updated list of CRO's in Turkey..

You can find the updated list of CRO's in Turkey on our webpages..

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The EFGCP Report on Research Projects in Europe; Turkish paragraph....

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe; Turkish paragraph is finalized (English). You can find the answers to most of your questions in this document.

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List of MoH Approved Bioequivalance/Bioavailability Centers..

You can find the list of MoH approved Bioequivalance/Bioavailability Centers in Turkey and abroad.

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EMA GVP modules are available for public consultation..


New legislation for pharmacovigilance will apply in the European Union as of July 2012, and the first 7 modules of the guidelines for the conduct of pharmacovigilance in the EU are now available for public consultation.

 



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Clinical Trials in Turkey: 1997-2011..

Basic statistics of Clinical trials in Turkey can be found in the attached document. The figures are from the manuscript published in Turkish GCP Journal ( www.iku-dergisi.com )  by Hilal İlbars from MoH.


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FDA is preparing a guidance on biosimilar drugs..


The guidance is prepared in order to promote biosimilar drug development and enhance competition. As outlined in the draft guidance, FDA recommends a stepwise approach in the development of biosimilar products.


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5th Annual CEE & CIS Clinical trials Forum..



The meeting will be held on 18-19 April 2012 in Vienna by Fleming Europe.

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The off-shoring of clinical trials outside the USA and Europe is reaching a plateau...

The increase of clinical trials outside USA and Europe seems to be reaching a plateau.

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FDA expands user fee programs..


The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients.



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Global ClinicalTrials: MENA Region

This is a report comparing and analyzing the countries in the Middle East and North America Region. You can find some data on Turkey separately. 

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Emergency Hospitalizations for Adverse Drug Events in Older Americans..


A study published in New England Journal of Medicine showed that emergency hospitalization for Adverse Drug Events in Older Americans mainly resulted from commonly used antitrombotic or anti diabetic drugs. Improved management of antithrombotic and antidiabetic drugs has the potential to reduce hospitalizations for adverse drug events in older adults.



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Open Source Cancer Research..

A mind opening talk from TED Talks. Jay Bradner is talking about open-source cancer research..


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All guidelines related to Clinical Research are now in English..

The guidelines that are active at this moment are translated to English by Association of Research-Based Pharmaceutical Companies (AIFD) and Association of Contract Research Organization Companies (SAKDER). You can reach the guidelines from our English webpage from the Documents menu on the left, following the Guidelines link. Read the news to see the list of the Guidelines.


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Google Maps of Human Disease..

Google is planning to create a massive data network  that would combine cutting-edge genomic and molecular data on patients' diseases with their routine medical records.


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Patients’ Motivation about Clinical Trials: A Local Perspective from Turkey..

The article ''Patients’ Motivation about Clinical Trials: A Local Perspective from Turkey'' prepared by Prof.Dr. Atilla Karaalp et al. was published in Marmara Medical Journal.


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2011 Regulation of clinical trials (revised translation)..


The revised English Version of the new regulation on Clinical trials is on our webpages.


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11th Annual Meeting of the International Society of Pharmacovigilance...


11th Annual Meeting of the International Society of Pharmacovigilance (ISoP 2011) will be held in Istanbul, Turkey from 26th to 28th October 2011.

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New EU pharmacovigilance (PV) legislation..

The EU recently adopted new pharmacovigilance (PV) legislation, that will be in effect by July 2012.

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The English Version of the GCP Regulation is on our web page..

You can find the complete guideline under Documentation - Regulations/Bylaw link on the main page.



New Bylaw on Clinical Research issued..

The new Bylaw on Clinical Research was published in the last issue of Official Newspaper. The bylaw will be valid after today.

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NIH dropped the Conflict Disclosure Plan for universities..


The plan would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers by using a web page.

 



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New Link..

A new link titled "data management companies" is available now..

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Implementation of Medical Research in Clinical Practice..



A report from the The European Science Foundation (ESF) on Implementation of Medical Research in Clinical Practice.

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New FDA Regulation to Improve Safety Reporting in Clinical Trials from NEJM..


The new regulation published by FDA covers the aspects of safety reporting. You can read about it in an article on New England Journal of Medicine.

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PharmaVoice, June 2011, article related to Turkey...


According to the article, Local R&D activity is gaining higher priority and resulting in a higher volume of clinical trials conducts in Turkey. Local and multinational companies are opening more R&D centers and engaging in scientific research partnerships. But the article also states that there are some obstacles to overcome.
 

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The first-ever randomized “virtual” clinical trial..

Pfizer Conducts First "Virtual" Clinical Trial.  

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First Balkan Clinical Trials Congresss..

First Balkan Clinical Trials Congresss will be held in Sofia between 3-5 November 2011..

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11th ISoP Annual Meeting..



The 11th International Society of Pharmacovigilance Annual Meeting entitled "Next stop: Istanbul – bridging the continents!' will be held from 25th to 28th October, 2011 in Istanbul, Turkey.

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FDA Webinar on Foreign Inspections..



On Tuesday May 17, 2011, the US Food and Drug Administration (FDA) will host a webinar that answers questions about the agency's foreign inspection program.

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New Law on Clinical Trials (2011)

The English version of the New Law that regulates Clinical Trials on Human Subjects is on the web page now..

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New Law on Clinical Trials is accepted..


The new law describes the role of Ministry of Health in Clinical Trials..

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Clinicaltrials.gov on NEJM..


New England Journal of Medicine published an analysis on Clinicaltrials.gov.

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Phase III trial failures..

The Centre for Medicines Research International has noted that the average for the combined success rate at Phase III and submission has fallen to ~50% in recent years. There were 83 Phase III and submission failures between 2007 and 2010.



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FDA's drug approvals in 2010..

The US Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) approved 15 new molecular entities and 6 new biologics in 2010. The total of 21 new products falls below the 25 approved in 2009 and the 24 in 2008.

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Scientific Fraud in Denmark..


A neuroscientist in Denmark who had published over 100 peer-reviewed articles has resigned after facing allegations that she committed research misconduct and misspent grant money. The University of Copenhagen has also recently paid back more than 2 million Danish kroner of the IMK General Fund grant that the foundation awarded to Penkowa. She left her position in the University after the accusations.

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A new website for FDA-Industry communication..


The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency.

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Happy New Year..


We wish a happy new year to all our readers..
Turkish Clinical Research Association.

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The 2011 Edition of the International Compilation of Human Subject Protections has been posted..



The 2011 Edition features a listing of over 1,000 laws, regulations, and guidelines on human subject protections in 101 countries. New countries added this year are Belarus, Grenada, Pakistan, Rwanda, and Tunisia.
 
This year’s Compilation also features the standards regarding device research, which were located in 44 countries.

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CTM last Issue..


Last issue of Clinical trials Magnifier analyses WHO Trials Registry Database..

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EMA report on trial participation and site inspections between 2005-2009..


61% of the patients who took part in the pivotal clinical trials used to support marketing authorisation applications submitted to the EMA between 2005 and 2009 came from third countries. Since 1997, GCP inspections have been requested for only 228 of the 44,034 investigator sites counted as part of the pivotal trials.

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NEJM: The Paradoxical Problem with Multiple-IRB Review..


The article discusses the multiple IRB review of multicentric trials and explains the problems..

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Hillary Clinton apologized for human research conducted in Guatemala..



The experiment, carried out in the 1940′s, was the act of inoculating prisoners, soldiers and mental patients with syphilis, without their knowledge or permission. Also Bill Clinton apologized for the Tuskegee study when he was the president of the USA. Tuskegee study was performed on African Americans with syphilis.
 

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New pharmacovigilance law was accepted by the EU parliament...



EU parliament clears new pharmacovigilance law.

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MedicReS International Conference on Good Medical Research..

"GOOD MEDICAL RESEARCH" titled International Conference of MedicReS is to take place in March 25-27, 2011 in Istanbul. Medical Researchers: AUTHORS, EDITORS, REVIEWERS from Turkey and abroad are to attend to the congress.

The aim of the congress is to discuss ETHICAL, HISTORICAL, BIOSTATISTICAL, METHODOLOGICAL, ECONOMICAL and LEGAL approaches to medical research with regard to the international standards in "GOOD PLANNING-GOOD ANALYZING-GOOD REPORTING-GOOD REVIEWING" main titles

 



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CTM Congress..



Clinical Trial Magnifier 2010 Congress will be held in Malaysia..

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GSK Opens Vaccine Clinical Research Center in Hacettepe Teknokent

GlaxoSmithKline (GSK) has opened Turkey’s first Vaccine Clinical Research Center in cooperation with Hacettepe University Teknokent A.Ş. GSK Vaccine Clinical Research Center will facilitate participation to international clinical studies from Turkey, as well as realization of national research projects.

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New FDA safety website for drugs with no problems..


The US FDA opened a new website on 15 June that provides the public updated information on drug safety with a major difference: unlike other FDA safety notification systems, this one spotlights not only reasons for caution, but also the far more frequent instances when a new drug has been found to have no unexpected safety concerns. The site is designed to be accessed by the general public as well as healthcare professionals.

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EC proposal on new clinical trial rules not expected until late 2011 ..


The European Commission says that the consultation exercise on the review of the EU clinical trials directive has yielded some useful information on the shortcomings of the legislation and that it is now looking at the various policy options for tackling them.

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Transparency at the FDA..


FDA started a new initiative to maintain a high level of transparency related to his regulatory affairs, inspections and other details.

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5 new guidelines..

The following guidelines are on now our webpages in English:

Guideline on Independent Data Monitoring Committees
Guidance on Observational Studies with Drugs
Guidance for the Preparation of Good Clinical Practice Inspection Reports
Guidance on the Format of Applications to the Ministry for a Clinical Trial
Guidance on Ethical Considerations for Clinical Trials on Medicinal Products with the Pediatric Population



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The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe - Turkey


The European Forum for Good Clinical Practice (EFGCP) Report on Turkey can be found as an attached file..

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Know-how transfer from Turkey to UAE in clinical research

AkademiKA ®  as a continuous GCP training program that has reached 800 health personnel in Turkey since 2003, has accepted its first foreigner investigators to the programme in 2008 in Istanbul. In 2009, the success that AkademiKA ®   achieved abroad, turned into a special training demand from United Arab Emirates.

 



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MoH announcement about audits to CROs in Turkey

According to the recent   announcement from Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals through their web site the Contract Research Organizations have to be audited by  Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals in order to conduct clinical research activities in Turkey.



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MoH- E-applications to Clinical Research Department started

According to the announcement from Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals through their web site ; starting from April 15th, 2010 all applications should be made both by paper format and electronic format. All documents in the applications dossier will be uploaded to IEGM2007 system by Ministry of Health (MoH) General Directorate of Pharmaceuticals.

 



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Danish case handling times for clinical trials in 2010


Danish Medicines Agency must handle applications for authorisation of clinical trials within 30 working days. The chart shows the case handling times for applications received by the Danish Medicines Agency during each month of 2010.

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