ProductLife Group Kicks off Autumn Event Programme With Regulatory Information Management Webinar on IDMP

Life sciences outsourcing and consulting services specialist ProductLife Group (PLG) has announced that the first event of its PLG Evolve autumn programme will focus on identification of medicinal products (IDMP) compliance.

The Webinar, “Taking a Strategic Approach to the Implementation of the IDMP,” to take place at 14:00 Central European Time on 18 September 2014, will be led by life sciences industry heavyweights who will discuss the challenges pharmaceutical and medical device suppliers face as they prepare to comply with new requirements around medicinal product information submission in time for a European Union deadline of 1 July 2016. By that date, affected companies will have to meet the new IDMP global standards of the International Organization for Standardization.

With less than 2 years to go to get product data in order, consultant Andrew Marr, an expert on the requirements stipulated by the latest product information standards, will copresent this timely session alongside Joerg Steuben, a Boehringer Ingelheim senior expert on quality and regulatory processes and documentation. The two will be joined by Sophie Daniel, head of quality, process, and information management at ProductLife Group.

Points of discussion will include
• The scope of IDMP from both regulatory and broader health-care perspectives
• The steps involved in bringing IDMP to fruition, including the development of IDMP implementation guides
• Assessment and monitoring of regulatory developments in the lead-up to IDMP
• What IDMP means for companies and how to achieve an effective and compliant transition from the latest eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) standard to IDMP, its successor.

Originally designed to aid in identification of substances and medicines for pharmacovigilance purposes, IDMP has evolved into something much broader and deeper than its XEVMPD predecessor. There is also growing interest in using IDMP data for broader health-care purposes; for example, to support medical history provision for patients being treated in other countries.

In announcing the opening event, PLG Chairman and CEO Pierre Cuny said: “We felt it was important to start our autumn schedule with a subject that will resonate with organisations right across our industry. Preparing for comprehensive product data compliance is no easy feat, especially now that the scope is so broad. Our speakers will be advocating a strategic, well-thought-out approach that creates maximum opportunity for companies to both satisfy regulatory requirements and deliver something beneficial for their businesses.”