Services platform
EVMPD
ProductLife Group offers advice, methodologies and expert resources to help you successfully conduct your EVMPD project. Indeed, ProductLife has all the tools and services to help you locate, collect and validate data that needs to be submitted. More than just help in conceiving XEVPRM messages, ProductLife offers transverse expertise to put in place the processes and information systems for your regulatory projects.
We invite you to discover our EVMPD Now offer. With EVMPD Now, our experienced teams can assist you through a packaged and modular service offering, adapted to effectively meet the needs of each laboratory.
EVMPD Now provides: Quick Start, audit, implementation, project management for your entire product portfolio. Each module of our offer is independent, so as to provide either a complete service or an adapted service in accordance with milestones that you may have already reached.
Modules EVMPD Now :
- Module 1: Gap Analysis
- Module 2: Pilot for a few Products
- Module 3: Creation of the EVMPD Data Base
- Module 4: Maintenance of the EVMPD data
- Module 5: IT System Intégration
Modules 1-3 will ensure that you meet the July 2nd 2012 deadline. Modules 4 and 5 enable you to setup routine and streamlined processes for your organization.
Key success factor with ProductLife to meet July 2012 deadline
- Methodology to find and gather all information in the current context of the client
- Strong expertise in CTD (40% of the information needed for XEVPRM)
- Ability to build a dedicated task force to gather and validate the data
Competitive Advantages for a long term partnership
Proven IT systems expertise:
- IT consulting teams with knowledge of transversal processes
- CTD projects + eCTD Outsourcing Platform
- Partnership with leading Regulatory software editors
Task force capabilities with European coverage:
- Large teams covering, Pharmacy, Regulatory, QPPV, PV Management, Medical writing, Publishing, IT Consultancy…
- Strong data gathering skills in regulated processes
EMA demands, that the SSI (“structured substance information”) has to be provided as XML contained within the Substance section of the XEVPRM. To fulfill the EVMPD requirements, each MAH has to submit the SSI for each substance contained in the medicinal product. Therefore, each pharmaceutical company has to provide detailed information on the active ingredient as well as on their excipients.
ProductLife offers to support companies by providing the needed, mandatory information of their SSI’s in an electronic format (e.g. Excel sheet). All we need is the list of SSI’s wanted. We will automatically extract the information for you (from the allowed sources); there is no need to dedicate extensive man power to this task.
About the EVMPD
A new European strategy for risk management
The EVMPD: a challenge and an emergency
The section on the registration of all products in EudraVigilance (EudraVigilance Medicinal Product Dictionary) is undoubtedly a major challenge in 2012 for the Chief Pharmacist and Services of Regulatory Affairs. The registration deadlines of July 2nd 2012, for each product are indeed short.
In addition, the number and type of data expected, entails great anticipation from the organization, information systems and cross-adaptation of workload for the teams involved. The remaining four months, until July, will result in considerable pressure on many regulatory affairs Managers.
After July 2012
A successful adhesion to the EVMPD by July 2nd, entails another major development with regards to the obligations of the EMA: to electronically submit the full side effects, as well as all coming variations, within 15 days .
Therefore, new processes for data exchange will have to be built as well as quality support systems in the PV and RA departments. Beyond July 2012 a second major project awaits pharmaceutical companies: a review of today’s transverse management of regulatory information.
Our teams are at your service
Your contact in France:
Olivier Bourdais, Sales Manager: obourdais@productlife-group.com +33 6 98 33 33 02.
Your contact in Switzerland:
Sebastian Schmitt, Director of Sales: sschmitt@productlife.ch +41 22 360 20 30
Your contact in Germany:
Jan Matthes, Country Manager Germany: jmatthes@productlife-group.de + 49-(0) 211-301 539-0
Latest News
Monday 26.03.2012
Exhibition in Copenhagen: Join us at the 24th DIA Euromeeting
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Monday 30.01.2012
Conférence à Paris: ProductLife participe à l'évènement sur la Cosmétovigilance organisé par la FEBEA
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Tuesday 24.01.2012
Kompaktseminar in Berlin: EVMPD - praktische Umsetzung bis Juli 2012
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