سال 14، شماره 1 - ( بهمن - اسفند 1398 )
جلد 14 شماره 1 صفحات 29-17 |
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Nafian F, Nafian S, Kamali Doust Azad B. Regulatory and Biosafety Challenges for Vaccines. Iran J Med Microbiol 2020; 14 (1) :17-29
URL: http://ijmm.ir/article-1-835-fa.html
URL: http://ijmm.ir/article-1-835-fa.html
نافیان فاطمه، نافیان سیمین، کمالی دوست آزاد بابک. چالش‌های نظارتی و ایمنی‌زیستی واکسن‌ها. مجله میکروب شناسی پزشکی ایران. 1398; 14 (1) :17-29
1- گروه بیوتکنولوژی پزشکی، دانشکده علوم پزشکی، دانشگاه تربیت مدرس، تهران ایران ، f.nafian@modares.ac.ir
2- گروه ژنتیک مولکولی، پژوهشگاه ملی مهندسی ژنتیک و زیست‌فناوری، تهران، ایران
3- گروه نانوبیوالکترونیک، دانشکده مهندسی برق و کامپیوتر، دانشگاه تهران، ایران
2- گروه ژنتیک مولکولی، پژوهشگاه ملی مهندسی ژنتیک و زیست‌فناوری، تهران، ایران
3- گروه نانوبیوالکترونیک، دانشکده مهندسی برق و کامپیوتر، دانشگاه تهران، ایران
چکیده: (4768 مشاهده)
برنامه جهانی نظارت بر تولید و توسعه واکسن‌ها، امکان دسترسی به انواع ایمن و کارآمد آن را باکیفیت تضمین‌شده فراهم می‌‌آورد. در این برنامه، چالش‌های مرتبط با فناوری‌های سنجش محصولات جدید بررسی میشود و درک جامع‌تری نیز از سود و زیان محصولات حال حاضر به دست می‌آید. در نظارت آزمایشگاهی، روابط حاکم بر ایمنی و سلامت ارزیابی و خواص محصول و توانمندی سنجش آنها بهبود داده میشود. سپس روش‌های بالینی آنالیز سود-زیان واکسن‌ها و استانداردسازی فرایند نظارتی طراحی میشود. هدف از دستورالعمل جهانی نظارت، تبدیل تلاش‌های فعلی آژانس‌های نظارتی به یک طرح اجرایی هماهنگ در حمایت از اهداف ایمن‌سازی جهانی است. در این مقاله، نقش دانش نظارت برای دسترسی مناسب‌تر به واکسن موثر تفسیر و شکاف‌های موجود در آن شناسایی بیان‌شده است. همچنین، چالش‌های پیاده‌سازی یک دستورالعمل واحد، بررسی و استراتژی رفع این نقایص مطرح میشود. هدف از ایجاد این دستورالعمل جهانی نیز اجرای اقدامات متحولانه توسط ناظران، دانشگاهیان و سایر ذینفعان است تا در حمایت از اهداف جهانی ایمن‌سازی واکسن‌ها، فرایندهای نظارتی هماهنگ داشته باشند.
نوع مطالعه: مقاله مروری |
موضوع مقاله:
بیوتکنولوژی میکروبی
دریافت: 1398/2/30 | پذیرش: 1398/5/29 | انتشار الکترونیک: 1398/12/24
دریافت: 1398/2/30 | پذیرش: 1398/5/29 | انتشار الکترونیک: 1398/12/24
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