DRUG in TURKEY - EU integration are DISCUSS IN ISTANBUL
European Medicines Agency (EMEA) by the "Regulation of Human and Veterinary Medical Products: Turkey's EU Membership Path" The conference has started in Istanbul. With the assistance of the European Commission and the Ministry of Health held a meeting of officials from the European Commission, EU member countries and experts from Turkey to join. At the meeting, the intellectual property rights, licensing, clinical research, especially to Turkey in many areas of pharmaceutical legislation - state of the EU harmonization process is being handled. At the meeting, a presentation of the Research Association Deputy Secretary General Nurgün Pharmaceutical Company orge, Turkey has taken important steps in alignment, but more work is said to be done.
23 October 2007, Istanbul. Turkey and other EU candidates Croatia and the European Union pharmaceutical legislation to ensure compliance, the EU Commission in support of the European Medicines Agency (EMEA)''was executed by Croatia and Turkey provided for the Multi-Sided Benefits Program''under the two-day conference Istanbul In Topkapi Eresin Hotel began. "Regulation of Human and Veterinary Medical Products: Turkey's EU Membership Path" from the conference, the Ministry of Health and European Commission officials, experts from EU countries and Turkey are involved.
Between joining the conference in Istanbul Metropolitan Municipality Erman Tuncer, Orhan Fevzi Gümrükçüoğlu Undersecretary of the Ministry of Health, Agriculture and Rural Affairs Deputy Director of EMEA Nihat Pakdil and Thomas has Lönngren.
The conference's first day in Turkey, data protection, drug registration are, especially for clinical research in different areas of the pharmaceutical legislation came to discuss the point. Health Ministry officials and sector representatives on this issue will be what has been done and were transferred. EU officials by providing information about the practices in Europe, Turkey's standards to harmonize with the EU should take steps were analyzed.
AİFD: "The progress is important and gratifying, but there is much work to be done"
Association of Pharmaceutical Companies in the conference Secretary General, Assistant Researcher Nurgün also gave a presentation motif. Sector progress and problems concerning the basic issues addressed in the orge said:
"In recent years our country to the EU level to remove the standards of the pharmaceutical sector, the harmonization of legislation in the process of membership to ensure that steps taken are very positive and gratifying. However, on the basis of issues that can not tell you eliminated. We have much work to be done. Development of the sector and our regulatory structure should be transparent. Thus, Turkey could see the front of the pharmaceutical sector, will be envisaged in. Problems that our country is another example that the data protection period of 6 years, actually the application of a shorter period of time. "
Orge şöyle devam etti:
"To reach the EU standards is very important for our industry. Thus, increasing our global competitiveness and more investment in world markets, ambitious, export capacity and advanced technology that uses a high floor of a pharmaceutical sector will be prepared. From this perspective, Turkey is scheduled to be established is very important Drugs and Medical Devices Agency. With a team will be made available to the autonomous structure, stability and confidence to create and industry can see the front of all units to ensure a transparent environment will contribute. Vision and strategy in the pharmaceutical sector in Turkey in terms of identifying needs to the forefront as a dynamic structure which is important out. "
Road map for EU candidate
''Croatia and Turkey provided for the Multi-Sided Benefits Program'', the European Union at a certain stage of compliance was recorded in the more advanced level of drug legislation to the EU on behalf of the licensing procedures conducted by the EMEA for the establishment of communications in progress. Involving both human and veterinary medicine in addition to the project of the Ministry of Health Ministry of Agriculture and Rural Affairs is also participating. EMEA technical and scientific meetings are being conducted under the legislation to be connected to the integration of the Turkish experts to participate in observer status. In this framework, Turkish experts, good manufacturing practices, good clinical practices and tracking of drug adverse effects and about the group meeting with the EMEA communication between member states' authority to official drug information network meetings were available.
Researchers Association of Pharmaceutical Companies (AİFD) About:
Since 2003 activities of the Association of Research Drug Company (AİFD) within the pharmaceutical firm has 37 researchers. www.aifd.org.tr
Wednesday, February 11, 2009
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