News & Events
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of excellent information not previously available in any published form. It covers notification, planning, conduct, documentation, system
Ennov to present the latest version of its game-changing RIM at the 2020 Global Pharmaceutical Regulatory Affairs Summit, Berlin, April 21-23
Ennov is pleased to announce that we will be exhibiting at the 2020 Global Pharmaceutical Regulatory Affairs Summit (GPRAS) being held at the Berlin Hotel Palace on April 21-23, 2020. We will present the latest version of our game-changing RIM,
Ennov and fme Life Sciences Announce New Partnership
fme Life Sciences to offer enterprise content and data management services in support of Ennov’s Regulatory solution suite. Ennov and global professional services firm fme Life Sciences are pleased to announce a new partnership that will provide an expanded portfolio
Ennov、2020 DIA Regulatory Submissions, Information and Document Management（RSIDM）フォーラムに出展
Ennovは、2020年2月10日～12日にメリーランド州ノースベセスダのBethesda North Marriott Hotel and Conference Centerで開催される「2020 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum」に出展することになりました。 DIAのRSIDMフォーラムでは、法規制情報の範囲を超えて活動している業界や法規制当局の関係者が集まり、現在のデータ標準や要件、関連システムを調整するための効果的な法規制情報管理アプローチを検討します。 2月11日（火）午後4時15分より、EnnovのKristen Mandello, DVMが「Automation, Efficiency, and Risk Mitigation in Regulatory Aggregate Report Writing」と題して、医薬品安全性監視に関する集計レポート作成における自動化の利点についてプレゼンテーションを行います。 ブース番号203にお立ち寄りいただき、薬機法規制文書管理、申請書パブリッシング、薬機法規制情報管理を網羅するEnnov統合薬機法規制ソフトウェア・スイートをぜひご覧ください。
Managing post-approval CMC changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. A wide variety of stakeholders are involved, from manufacturing/supply change to corporate quality to regulatory affairs and regulatory operations. A diverse set of independent or loosely
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will submit a single submission in electronic format. Because a medical device premarket submission in electronic
Ennov to Sponsor 9th TMF Summit and CROWN Congress January 21-23, 2020 in Orlando, FL
Ennov is pleased to announce that we are sponsoring the 9th Trial Master File Summit and CROWN Congress being held at the Sheraton Lake Buena Vista Hotel in Orlando, FL on January 21-23, 2020. Both conferences focus on improving clinical
RIM Webinar – Understand the Basics of RIM in 30 Minutes
Dec 10th at 11 AM – 11:30 AM PST | 2 PM – 2:30 PM EST With the increasing complexity of the global regulatory landscape, Regulatory Information Management (RIM) is at the heart of the decision making process for pharmaceutical
Ennov Recognized by Garner in Multiple 2019 Research Reports
Ennov announces its inclusion in four 2019 Life Science market research reports published by Gartner, Inc. the leading information technology research and advisory company. The following reports recognize Ennov solutions: Hype Cycle for Life Science Research and Development Hype Cycle
6 Considerations for Selecting an Electronic Data Capture (EDC) Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the big, well-known EDC providers, to the small not so well known vendors, to homegrown EDC