AkademiKA

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2009 Term

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"Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects."

From the 13 Principles of ICH (E6) GCP Guidance of Helsinki Declaration

AkademiKA Program is initiated by sanofi-aventis in order to support the development of an infrastructure conforming to universal criteria on the subject of “Good Clinical Practice” in our country.

Objectives of AkademiKA are, formation of researchers well-educated and sensitive to international standards on good clinical practice, recognition and application of good clinical research principles completely, and comprehension of significance of clinical research.

AkademiKA, in this scope, is a scientific training program aiming to inform the research doctors and other medical professionals participating or willing to participate in clinical research activities in Turkey.

With the AkademiKA program, sanofi-aventis intends to present its global experience to the service of “Better medical future for Turkey” with participation of our distinguished doctors.

AkademiKA is the short name of Program for Sharing of Good Practice Principles on Clinical Research, achieved with the support of sanofi-aventis.

Commission issues ethical recommendations on trials in children

The European Commission has published a guideline on the ethical standards to be applied when clinical trials are conducted with children.

Commission consults on paediatric entries for EudraCT

The European Commission has put out for consultation draft guidance on paediatric study information to be included in the European Union’s clinical trial database, EudraCT.

FDA and Duke Collaborate to Modernize Clinical Trials

The U.S. Food and Drug Administration (FDA) and Duke University Medical Center have begun a collaboration aimed at modernizing the way clinical trials are conducted.

FDA Clinical Trial Requirements Regulations, Compliance, and GCP Conference

SoCRA (Society of Clinical Research Associates) is pleased to announce this conference that is jointly sponsored with District/Regional offices of the U.S. Food and Drug Administration.

Protocol complexity is increasing trial burden, Tufts study says

The growing complexity of clinical trial protocols is making life more difficult for site personnel and study volunteers alike, warns a new study by the US-based Tufts Center for the Study of Drug Development (Tufts CSDD). The outcome, it says, is longer clinical trials and increasing problems with recruiting and retaining patients.

Revised clinical trial portal provides email alerts and improved searching

The International Federation of Pharmaceutical Manufacturers & Associations has launched an improved version of their clinical trial portal aptly named, “MyPortal.”

Inspection procedures for the coordination, preparation, conduct and reporting of GCP inspections for CAPs;

The EMEA published several procedures for the coordination, preparation, conduct and reporting of Good Clinical Practices (GCP) inspections carried out in the context of the Centralised Procedure.

EU: EMEA Training Course in Pharmacovigilance: Clinical Trials and post-marketing

EMEA will hold a Pharmacovigilance Training Course called “Excellence in Pharmacovigilance - Clinical Trials and Post Marketing” on February 11-15, 2008 at Paris, France.

Request for Comments: EU/US-GCP: Revisions to the Declaration of Helsinki

The World Medical Association has initiated a request for comments on, "Revisions to the Declaration of Helsinki."

Turkey's Road to EU Membership

It is a great pleasure to announce the conference ”Human & Veterinary Medicinal Products Regulation

GCP: Good Clinical Practice (GCP) in Today s Changing Environment

This event will look into key issues surrounding Clinical Trials and GCP. A detailed overview of the current topics encountered and considered in today’s environment as a result of government targets, counterfeit medicines, exchange of information, Phase 1 Accreditation Scheme and serious breaches.

Office of the inspector general releases report on FDA oversight of clinical trials:

Inspector General Daniel R. Levinson of the Office of Inspector General for the Department of Health and Human Services has announced the release of a report, "Food and Drug Administration's Oversight of Clinical Trials," which contains an analysis of two key issues: to determine the extent to which the FDA conducted inspections of clinical trials from fiscal year FY 2000 to FY 2005 and to assess FDA’s processes for inspecting clinical trials.

European Commission and EMEA to hold conference on EU clinical trials legislation

A joint conference of the European Commission and the European Medicines Agency (EMEA) will be held on 3 October 2007 to discuss the current legislation on clinical trials for medicinal products and its implementation in the European Union. The conference, which will be attended by invited representatives of major stakeholder groups, will focus on evaluating the operation of the Clinical Trials Directive and providing recommendations for its future development.

EMEA works with patients and consumers by providing information about medicines

The European Medicines Agency (EMEA) has a role to play in this empowerment of patients and consumers. As the European Union's official body for the evaluation and supervision of medicines, the EMEA has a wealth of information to share with patients and consumers about the latest developments in this field. The Agency makes this information freely accessible to support and encourage widespread public understanding of medicines and their use.

US - GCP: OHRP publishes new FAQ on informed consent

The Department of Health and Human Services Office for Human Research Protections has announced the availability of a new set of Frequently Asked Questions and Answers on Informed Consent. These FAQs provide guidance on OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited.

Pediatric clinical trials

All clinical trials performed in the European Union are registered in a database called EudraCT. This database will now include all trials performed anywhere in the world with children, if the trial is part of a paediatric investigation plan.

Clinical trial registration - looking back and moving ahead

In an editorial recently published in leading medical journals, the International Committee of Medical Journal Editors says its 2005 policy requiring investigators to deposit information about trial design in an accepted clinical trials registry before starting patient enrollment has drawn an overwhelmingly positive response.

AHRQ publishes guide to patient outcome registries

The Agency for Healthcare Research and Quality has published the "Registries for Evaluating Patient Outcomes: A User's Guide," which lays out the essential components of designing, conducting and assessing registries and provides best practices for enhancing the studies. The Guide was developed by Outcome Sciences under AHRQ's "Developing Evidence to Inform Decisions about Effectiveness Network," a part of the agency's Effective Healthcare Program.

Commission offers guidance on clinical trial drugs

The European Commission's Enterprise and Industry Directorate-General has published new guidance clarifying what is meant by an "investigational medicinal product" in the context of a clinical trial. It also - and in substantially more detail - gives advice on the use in clinical studies of other medicines that do not fall under this definition.

‘First-in-man’ clinical trials guideline released for public consultation

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products. The draft guideline is being released for a two-month public-consultation period.

Protecting Human Subjects Involved in Clinical Investigations: A Continuum from Design to Completion.

FDA's Office of Critical Path Programs and DIA are co-sponsoring a first-of-its-kind workshop on "Protecting Human Subjects Involved in Clinical Investigations: A Continuum from Design to Completion."

AkademiKA Program 12th Organization was held

AkademiKA Program 12th Organization was held on the dates 16-18 February 2007.

2008 Term AkademiKA Organization Started

AkademiKA continues the scientific training programs, prepared to inform the research doctors and other medical professionals participating or willing to participate in clinical research activities, in 2008.

Number of Clinical research rooms founded by the support of sanofi-aventis reaches 30.

To the activities we have initiated for the formation of a clinical research infrastructure conformant to international standards in our country, we add another after AkademiKA Training Program: Clinical Research Rooms.

© 2006 sanofi-aventis. All rights reserved.