Ennov User Meeting
April 22 - 24, 2024
Clearwater Beach, FL
About the Ennov User Meeting 2024
- The meeting will take place April 22 – 24, 2024 at the Sheraton Sand Key Resort
- The meeting will begin each day at 8AM and end at 5PM (Monday and Tuesday)
- The meeting will close at noon on Wednesday
- New for 2024! A Welcome Reception will be held on Sunday from 6:00 – 7:30PM
- Breakfast and lunch will be served each day
- The evening event will be held on Tuesday from 6:00 – 8:00PM
The Ennov User Meeting is a great opportunity to:
- Attend advanced training sessions on Ennov products
- Discover new software versions and modules
- Preview upcoming product enhancements
- Network and exchange best practices with other Ennov customers
- Gain valuable business insights based on the group’s collective industry experience
Agenda
Thursday, Sep. 21
Friday, Sep. 22
Thursday, Sep. 21
Thursday, September 21, 2023
Session 1 9:00am – 10:30am
Ennov in 2022/2023 Overview – Sales & Marketing – Quality – Hosting & Security – Professionnal Services – Product Strategy
A comprehensive overview of the previous year’s highlights and plans for the current year. Provides a 360° view of sales activities, product strategy and customer delivery, including hosting, security and quality.
MORNING BREAK
Quality
Regulatory
Clinical
Human PV
Session 2 10:45am – 12:15pm
V10 Quality Core Model Presentation: Scope & Roadmap
Present the data model, new deliverables (URS, Validation kit) and features of the Quality Core Model v2.1. and Ennov Platform v10 Describe the road map of future implementations.
Ennov Dossier v10.0
New enhancements and new specifications supported in Ennov Dossier v10.0.
Samarind Product Update
Samarind RMS Product Enhancements.
Guided Tour to Ennov V10 EDC (1/2)
Presenting the latest Ennov V10 EDC solution demonstrating the changes made in 2023.
Ennov PV Human: what’s new?
An overview on our latest PV Human solution set and the corresponding release plan; as well as providing an update on our leadership team.
Session 3 1:45pm – 3:15pm
Supplier Management: How to manage your supplier interactions and records in V10
Manage the Master Data records (Substance, Product, Equipment Organization, Location sites) and see the an example of integrations with Ennov Connectors.
Submission Document Core Model
Description of the Submission Document Core Model, links between SDCM and RIM, new enhancements of the SDCM.
Introduction to the Ennov platform for Samarind customers
Overview of the key features of Ennov platform for Regulatory, and gap analysis with Samarind RMS.
Guided Tour to Ennov V10 EDC (2/2)
Presenting the latest Ennov V10 EDC solution demonstrating the changes made in 2023.
The Details of PV-Entry and PV-Admin
Feature overview of PV-Entry and PV-Admin, through demonstration and supporting slides (include core model and client specific configurations).
AFTERNOON BREAK
Session 4 3:30pm – 5:00pm
V10 Document Management: How to manage your GMP documents trought the artifacts
Manage the GMP Document records (Document Life cycle) and how to leverage the GMP artifact.
V10 Ennov Analytics: Using and configuring KPIs for Regulatory
Presentation of the Ennov Analytics capability and its applications to regulatory to build KPI and monitoring dashboards.
Ennov Clinical Product Update
Ennov Clinical 2023 product information and strategy for 2023.
MACRO Product Update
MACRO 2023 product information and strategy for 2023.
The Details of PV-Reporter
Feature overview of PV-Reporter, through demonstration and supporting slides (include core model and client specific configurations).
Friday, Sep. 22
Friday, September 22, 2023
Quality
Regulatory
Clinical
Human PV
Session 1 9:00am – 10:30am
Quality Management: How to manage your deviations to CAPAs process
Manage your QA activities from the creation of a deviation to the implementation and effectiness checks of the corrective and preventive actions.
A quick taste of RIM data migration
Prepare RIM data migration on a concrete but simple example.
Medical Devices & Combination products RIM Core Model
Presentation of the RIM Device Core Model, the management of Device registration and data management.
eTMF Completeness, Timeliness and Quality: From chaos to order
Demonstration of eTMF and presenting the latest updates to eTMF. Examples of receiving data from EDC and storing files ready for regulatory inspections.
The Details of PV-Dashboard
Feature overview of PV-Dashboard, through demonstration and supporting slides, with a focus on the use cases it fulfills and the functionality it provides above PV-Reporter.
MORNING BREAK
Session 2 10:45am – 12:15pm
V10 Learning Management: How to manage your training records
Manage and maintain your employee training records, and how to develop your learning programs including instructor-led classroom or on-the-job training.
xEVMPD: Reg. affairs or Reg. ops?
Presentation of the xEVMPD solution and implementation, with a focus on the source and management of xEVMPD data.
Migrating from Samarind to Ennov Regulatory platform
Description of the process to migrate from Samarind to Ennov. Extracting, Transforming (and enriching), loading data.
Ennov CTMS: Driving insight and transparency in clinical trial management
A walkthrough of CTMS and integration points with eTMF and EDC. Watch how the CTMS can make managing your study easier in a central system.
Signal Detection and Signal Manager
Feature overview of Signal Detection and Signal Manager, through demonstration and supporting slides (include core model and client specific configurations).
LUNCH BREAK
Session 3 1:45pm – 3:15pm
V10 Ennov Analytics: How to use your search and dashboard features
Manage your Cross-Object Search and Standard KPI Dashboard for real time reporting with business use cases trought Suppliers, Documents, and Quality records.
V10.x Regulatory wishlist
What would you like to have next in V10.x for Ennov RIM and for Ennov Dossier?
eLearning for Investigators and CRA
Presentation of the eLearning platform set up by Ennov Clinical.
Integrating MACRO with Ennov CTMS
See how MACRO patient data can automatically populate Ennov CTMS.
Management of Adverse Event in clinical trials. Reconciliation between the EDC and PV solutions.
Information on how our solutions manage Adverse Events, originating in Clinical Trials.
AFTERNOON BREAK
Session 4 3:30pm – 5:00pm
V10.x Quality Wishlist
Professional game to brainstorm and discuss the development opportunities on the Ennov Quality Core Model.
IDMP and DADI 101 – be proactive!
Regulatory update on IDMP and presentation of the Ennov IDMP solution, with focus on how to best prepare.
Ennov Inbound / Outbound connector
Simplified connection with external systems using Ennov Inbound / Outbound connector.
V10.x Clinical wishlist
Bring your own thoughts, after seeing and speaking about V10 it’s time to hear from you. What would you like to see next in V10?
Other Topics: Reg Updates, Our Other PV Tools, Transitioning from PV Works
Information on the latest federal regulations impacting the PV-Human process and our solutions, discuss our other PV tools (e.g. PV Express, PV Importer), and topics surrounding transition from PV-Works to PV-Entry/PV-Reporter.
Hotel and Transportation
The Ennov User Meeting 2024 will take place at:
We have negotiated a discounted room rate of $250 (USD) per day for the conference. Current city and state room taxes are approximately 13% per day.
A block of rooms has been reserved from the night of Sunday, April 21 to the night of Wednesday, April 24, 2024. Room reservations should be made and paid for directly with the Sheraton Sand Key Resort by using the link below or calling +1 727-595-1611 and asking for in house group reservations. If you are booking online, please be sure to choose your arrival and departure dates via the drop-down arrow in the “DATES” section prior to hitting the “CHECK AVAILABILITY” button. DO NOT LEAVE DATES AS DEFAULT.
A one-night deposit will be taken at the time of booking. Should you need to cancel your reservation you will have up to 48 hours prior to arrival to cancel and receive your deposit back.
If booking any dates before or after the conference dates, please call the hotel or email [email protected].
Reservations must be made before March 24, 2024
Cost and Registration Process
The per attendee registration fees for 2024 Ennov US User Meeting are as follows: Standard Rate (per person): $1200
The registration fees cover the cost of the meeting rooms, breakfast, morning and afternoon breaks, lunches (Monday – Wednesday) and the evening event on Tuesday.
- The following registration policy will apply:
- All attendees must pay in advance of the meeting and by paying, your registration will be “confirmed”. Please make sure that your payment includes your name otherwise we will not know who is registering!
- The registration fee is set at a “per person” level (not “per company”). A single combined payment of multiple registration fees is acceptable provided it is clear which attendees it covers!
- Registrants who have not paid in full prior to the meeting will be unable to attend.
- Attendees will be able to transfer their registration to colleagues in the same organization if they need to cancel. Regretfully, it will not be possible to offer refunds in the event that an attendee needs to cancel or cannot attend.
- Attendees paying electronically must ensure that all bank fees are met by the sender. Since this meeting fee is to cover expenses it is important that the full fee is received by Ennov; otherwise the registration will be invalidated.
The per attendee registration fees for 2024 Ennov US User Meeting are as follows:
| Standard Rate (per person) | Early Bird Rate* (per person) | Group Rate** (per person) |
| $1200 | $1100* | $1000** |
*applicable for registrations made before January 31, 2024 **applicable to companies registering at least three members for registrations made before January 31, 2024 | ||
The registration fees cover the cost of the meeting rooms, breakfast, morning and afternoon breaks, lunches (Monday – Wednesday) and the evening event on Tuesday.
- The following registration policy will apply:
- All attendees must pay in advance of the meeting and by paying, your registration will be “confirmed”. Please make sure that your payment includes your name otherwise we will not know who is registering!
- The registration fee is set at a “per person” level (not “per company”). A single combined payment of multiple registration fees is acceptable provided it is clear which attendees it covers!
- Registrants who have not paid in full prior to the meeting will be unable to attend.
- Attendees will be able to transfer their registration to colleagues in the same organization if they need to cancel. Regretfully, it will not be possible to offer refunds in the event that an attendee needs to cancel or cannot attend.
- Attendees paying electronically must ensure that all bank fees are met by the sender. Since this meeting fee is to cover expenses it is important that the full fee is received by Ennov; otherwise the registration will be invalidated.
Standard Rate
Standard Rate
Information about Payment with Electronic Transfer
Bank address
Handelsbanken (sort code 40-51-62)
Byron House, Cambridge Business Park,
Cowley Road, Cambridge, CB4 0WZ, UK
| Currency | Bank account number details |
| USD | Account number: 25402002 IBAN number: GB76HAND40516225402002 SWIFT Code: HANDGB22 |