Events & Activities
Everything is easier with a repeatable process. CARA provides the tools to create consistent global submission processes, as well as the flexibility to tackle ad-hoc submissions and agency interactions
Understand what is used, submitted, & approved in any market
CARA’s flexible ’Current Approved View’ and ‘Where Used’ functionality provides instant visibility for regulatory users to understand what has been submitted and where. Automated relationships ensure a smart web of content, submissions and plans to provide instant oversight
Eliminate double-work: use your existing templates & content
Global Events with templated core and local submission structures can save weeks of planning and communication, and provides down-stream consistency in your global submissions
Stop re-inventing the wheel for each submission
Although no two submissions may progress the same way, CARA’s process-driven flexibility allows for variations to the same standardised approach for submission across the business. Generis also provides a best practice process package to help your business structure and operate in alignment with our most innovative and successful customers
Create & manage submissions, not just documents
Global submissions can necessitate lengthy, phased and incongruous submission paths in different markets. Even when Health Authority approval is granted in a particular market, it can be challenging to understand what was submitted and approved in that market, and which other in-progress submissions that approval might effect. Key feedback and communication with local authorities can also provide insight, aid or criticism that should be reflected or enacted across the other in-progress submissions.
RIM on the CARA Life Sciences Platform provides ‘Event’ and ‘Activity’ mechanisms for managing and linking Global and Local submissions.
Regulatory Events in CARA manage the submission information from planning to approval and closure for a global submission initiative. This also includes a templated global content plan, or core dossier, of the content that might be used as a starting point for submissions in local markets. Once planning is complete, the local submission information and content plans, ‘Activities’, are automatically generated and linked. Affiliates can then manipulate and author these individual submissions based on their local requirements.
The generated relationships and automations between CARA’s Events and Activities ensure that any modifications, positive opinion or approval information is visible instantly at hand from the global oversight level to the individual document author.