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            [PERMISSION] => Z
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            [DEPTH_LEVEL] => 2
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Ежегодная конференция ISPE ЕАЭС


9-10 ноября в Санкт-Петербурге при поддержке Минпромторга России состоится третья Ежегодная конференция Евразийского отделения Международной ассоциации фармацевтического инжиниринга (ISPE ЕАЭС).

Конференция ISPE ЕАЭС – мероприятие с насыщенной деловой программой, в рамках которой представители регуляторных органов Евразийского региона, профильных ассоциаций, производителей лекарственных средств, инжиниринговых и консалтинговых центров, проектных бюро, поставщиков промышленного и лабораторного оборудования в ходе дискуссии и обмена опытом вырабатывают решения и находят ответы на актуальные вызовы развития фармацевтической отрасли. Отличительной чертой и своего рода визитной карточкой конференции является возможность посетить лучшие фармпроизводства страны.

В этом году мероприятие откроет круглый стол по вопросам бесперебойных поставок лекарственных средств в контексте стратегической безопасности государств и граждан и повышения конкурентоспособности национальных производителей. Также участники конференции из первых уст узнают о произошедших за последний год изменениях международных требований и внутреннего законодательства, обсудят с какими сложностями им пришлось столкнуться при этом и представят кейсы успешного преодоления возникших проблем. Традиционно в рамках первого дня представители фармкомпаний поделятся опытом практического применения на своих заводах Руководств ISPE.

Второй день Ежегодной конференции ISPE ЕАЭС откроет сессия по стерильному производству. «Эта тема была подсказана нашими европейскими коллегами на прошедшей весной конференции в Мадриде, где обсуждался процесс принятия Приложения №1 (Annex 1) к Правилам GMP ЕС, - рассказывает директор ISPE ЕАЭС Владимир Орлов. – Тогда мы услышали много вопросов от мирового фармсообщества касательно применения принципов управления рисками (QRM) в стерильном производстве. Поэтому решили развить данную тему и на просторах ЕАЭС. А сейчас, после вступления в силу обновлённой версии Annex 1 в конце августа, дискуссии экспертного сообщества должны перейти уже к практической реализации принципов, указанных в новом документе».

Продолжит сессию по стерильному производству экспертный круглый стол о методах и подходах, оборудовании и лучших практиках мониторинга производственной среды, организованный при поддержке ООО «биоМерье Рус». И, конечно же, с учетом прошлых лет и сохраняющегося запроса на интеграцию цифровых решений в фармацевтике, 3 ч будет отведено дискуссии целостности данных на всех этапах жизненного цикла лекарственных препаратов, партнером которой выступит компания «Акелон». В рамках этой сессии Евразийское отделение ISPE представит итоги опроса по интеграции операционной модели Pharma 4.0 в производство. «Если вы еще не прошли опрос, приглашаем вас это сделать до 5 ноября, ответив всего на несколько вопросов. Тогда уже на конференции и ваша компания сможет получить ответы и рекомендации от ведущих экспертов по практическим аспектам, рекомендации по внедрению цифровых решений на производстве», - напоминает заместитель директора ISPE ЕАЭС Оксана Пряничникова.

11 ноября – это день визитов на производственные площадки Санкт-Петербурга и Ленинградской области (опция предусмотрена для участников, выбравших дополнительный пакет «Экскурсия»).

Зарегистрироваться на Ежегодную конференцию ISPE ЕАЭС можно на официальном сайте мероприятия conference.ispe.ru.

Партнером регистрации выступает интернет портал proGMP.ru. Специальный партнер регистрации - PQE (ООО «ПИКЬЮИ СИАЙЭС»).

По вопросам спонсорской поддержки и участия обращайтесь к техническому организатору «ЦКК C-Груп»:

+7 (495) 120-53-33

conference@sgr.com.ru

Время и место проведения мероприятия: 9-10 ноября, отель Кортъярд Санкт-Петербург Центр (наб. канала Грибоедова, 166).


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