8th Annual Global Pharma Regulatory Summit
Venue: The Lalit Mumbai, India
Navitas Life Sciences will be present at the 8th annual Global Pharma Regulatory Summit from 29 -31 May 2019 at The Lalit Mumbai, India. Raj Srinivasan, VP – Business Partner, Safety & Regulatory will be speaking on the topic "Journey towards regulatory excellence by leveraging technology" on Day 3 of the summit. pharmaREADY will also be demonstrated at the summit.
The 8th Edition of Global Pharma Regulatory Summit is a platform where key leaders and experts of regulatory affairs, compliances, quality assurance and policy makers discuss the current trends and challenges in global regulatory landscape. The forum will discuss the latest challenges in the regulatory environment and examine the impact of new initiatives for emerging markets, review the global perspective of regulatory system and understand how companies world over will revamp pharma regulatory strategies.
For further information, or to register your interest, please fill out the form:
https://navitaslifesciences.pages.salesfusion.com/8th-Annual-Global-Pharma-Regulatory-Summit-2019
Venue: Baltimore, Maryland
Navitas will be highlighting regulatory operations outsourcing solutions, along with eCTD software, at the Regulatory Affairs Professional Society (RAPS) annual meeting.
The solutions highlighted will include Submissions & Report Publishing, License Maintenance, Labeling & Artwork Services, Regulatory Information Management and Regulatory Strategy & Support. Additionally, pharmaReady®, Navitas’ suite of fully integrated regulatory document management system, from document creation through regulatory submissions, will be demonstrated.
Webinar: EDM Submission Reference Model - Shaping how submission content is managed
Venue: 10:00–11:00 Eastern Time
Navitas’ content management practice lead, David Gwyn, will be speaking on the EDM Reference Model. IRISS is recognized as a pharmaceutical industry trade organization, which provides a mechanism for IRISS (Implementation of Regulatory Submission Standards) to collaborate with other trade organizations within the pharmaceutical industry (i.e. PhRMA, DIA, RAPS, HL7) as well as global health authorities.
Mr. Gwyn’s presentation “EDM Submission Reference Model - Shaping how Submission Content is Managed” will showcase the output of DIA’s (Drug Information Association) EDM Submission Reference Model team and present the background of how the model was created, where it is today and the future roadmap of development. The session will conclude with information on how to obtain the model and how to participate in future activities. The topic and content are the output of DIA’s (Drug Information Association) EDM Submission Reference Model team that Mr. Gwyn led.
Register Now!
Webinar - FDA’s Requirements for eCTD Submissions
Time: 2 PM EST
Webinar will cover:
- New regulatory requirements – and their advantage
- Organizational challenges
- How to prepare – quickly – for submitting applications electronically
- Document granularity considerations
- What to do with legacy documents
- Document templates – not optional
- How to use the FDA’s Gateway and more
For further information please email This email address is being protected from spambots. You need JavaScript enabled to view it.
CARA for Documentum & Alfresco in the Cloud
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CARA for Regulatory Information Management
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CARA for eTMF
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum and Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the fourth in a six-part series showcasing CARA as the next generation user interface.
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CARA for Regulatory Affairs and Submission Management
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum and Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the third in a six-part series showcasing CARA as the next generation user interface.
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CARA for Controlled Content / Quality Document Management
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the second in a six-part series showcasing CARA as the next generation user interface.
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