Implementation of XEVMPD has been challenging for everyone involved due to short timeframes, deadlines and changes in the technical requirements. ISO IDMP (Identification of Medicinal products) legislation which will come into effect in mid-2016 brings about a global scope and the requirement for data integration across the companies. Comprised of five ISO standards, the purpose of IDMP legislation is to standardize the identification of medicinal products and thus improve pharmacovigilance across products, companies and jurisdictions. ISO IDMP is much more of a challenge than XEVMPD.
This live webcast will not only bring you up to date with currently available IDMP implementation guidance, but shall also evaluate the impact by interpreting it and defining essential initial activities.
We will help you find answers to these questions:
- Which parts of the guideline are straightforward and doable, which areas are complex yet feasible, and where are further guidance needed?
- How to leverage controlled vocabularies?
- Is it clear where roles and responsibilities lie within your organisation?
Upon attending this live webcast, you will be able to:
- Better understand the IDMP legislation
- Identify data at hand and learn how to draw together the data you do not have
- Draw and maintain information about packaged medicinal products to prepare for IDMP compliance
- Identify activities to start working towards a single, authoritative data repository
Join the conversation: http://bit.ly/LinkedIn_IDMP
Get your own copy of the Guide to ISO IDMP: http://www.infotehna.com/Guide_to_ISO_IDMP
INFOTEHNA, euroscript’s Center of Excellence for Life Sciences, is a worldwide pioneer in the development and delivery of integral enterprise regulated content and process management, as well as regulatory compliance solutions for life sciences industry. Our benchmark myPharmaExpert SuiteTM is a unique, Integral by DesignTM software solution which helps life sciences companies ensure Quality, Efficacy and Safety of their products.
myPharmaExpert SuiteTM is a proven solution capable to support individual compliance relevant processes pertinent to R&D, Regulatory Affairs, Clinical trials, Manufacturing, and QA/QC. Notwithstanding, thanks to its integral design, it allows to encompass the entire spectrum of enterprise compliance management functionalities in just one place. This combination empowers companies to seize upon synergies that result in a lower complexity, higher overall quality and increased compliance.
Incorporating 25-year experience and an in-depth industry knowledge, it enables transformation of Life sciences businesses by helping them to scale down the overall product lifecycle management efforts, by promoting standardization across enterprises and by shortening time-to-market.
If you would like to learn more about the ‘Impact and Considerations for Implementation of IDMP’ then join INFOTEHNA’s webinar here.