EVMPD Hot issues: insight in scope and format of information
Sponsored by: INFOTEHNA
Date: 28 February
Time: 3PM London/ 10AM New York
How are you going to meet the European Medicines Agency’s Monday 2nd July 2012 deadline?
At the moment there are just over 500,000 products that will be affected by the new European Medicines Agency (EMA) regulatory change that becomes mandatory at the start of July this year. The introduction and imminent implementation of EudraVigilance Medicinal Product Dictionary (EVMPD) has set the Life Science Industry into hyper-drive as everyone seeks to adhere to protocol in their own way.
Does your company have a registered product in Europe? Or is your company aiming for a product, or trial of a product within the EU? More than likely, Yes.
The EMA have been slow with releasing assistance on interpreting and applying of EVMPD protocol. The main objective of the EVMPD is to assist the pharmacovigilance activities in the European Economic Area (EEA). As such, the EVMPD has been designed to support the collection, reporting, coding and evaluation of medicinal product data in a standardised and structured way.
From the deadline you and your company will have to meet the demands of the EVMPD mandate. Companies have an enormous task in preparing the data needed to meet EVMPD practices and keeping it updated all electronically and online.
This session will break through the haze that is surrounding the biggest changes to regulations in decades. It will be exploring the challenges using EVMPD with in-depth guidance and detailed information then exploring ways of overcoming these regulatory obstacles.
Places are filling up fast from top level management whose company needs to use the regulations, to middle management who have to educate a workforce to ensure successful implementation.
Sinisa Belina, MSc. Pharm.,
Product development, Process improvement at INFOTEHNA Group LLC
Mr. Belina started his professional career in PLIVA (TEVA Group member), renowned for its highly competent employees, innovative technologies and continuous investments in production. In addition to his responsibilities in manufacturing, he was part of the very successful Electronic Document Management System (EDMS) implementation project.
In 2007 he joined KRKA, one of the largest generic pharmaceutical companies worldwide, where he worked in Regulatory Affairs department. With years of experience in pharmaceutical business, Sinisa moved to INFOTEHNA as a Life sciences consultant and then he was promoted to Business Services Assisstant Director. He applies his detailed knowledge of pharmaceutical documentation and processes principally to areas of business process analysis and optimization of electronic document management systems.
Andrew Marr, PhD,
Managing Director at Marr Consultancy Ltd
Andrew has a wide range of regulatory experience underlying thorough knowledge of document management and electronic submissions. Industry lead on numerous industry/agency projects to enhance e-submission management.
Strategy consultant, highly respected in the pharmaceutical sector. Extensive expertise in electronic submission requirements and processes in Europe and US gained from pivotal involvements throughout their development and successful implementation. Extensive experience of the Product Information Management (PIM) programme gained as industry lead since its inception. Extensive network and reputation with regulators, industry and software vendors working in these spaces.
Specialties: Electronic submissions, document management, regulatory affairs, regulatory operations, project leadership, agency liaison, standards development.
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Key Learning Objectives
- Understanding EVMPD guidance documents
- EVMPD submission challenges and how to tackle them
- Identification of information and documents needed for successful EVMPD submission
- Using eMPDExpertTM to manage EVMPD information and build XEVPRM
- CEO Leve Executives
- Regulatory Affairs managers
- Regulatory Affairs experts
- Regulatory Operations managers
- Regulatory Operation experts
- Pharmacovigilance managers
- Pharmacovigilance experts
- IT managers