Providing and maintaining standardized IDMP data will have a far-reaching impact and is a challenge that life science companies with products approved in the EU must address.
With the deadline quickly approaching for companies to begin their IDMP Iteration 1 submission, many need to regroup to ensure they’re prepared to comply with the new standards.
In this interactive, no-slides discussion, members of the IDMP Task Force re-surface the intention of IDMP, provide an update on key upcoming dates, and answer your questions about overcoming implementation challenges and what factors should be considered currently – and in the future – as the industry takes this important next step for structuring product information to safeguard patients.
Director Regulatory Information, RIM Consulting, Calyx
Karen Harry has extensive industry experience in Regulatory Operations and Regulatory Information Management particularly in the implementation of regulatory processes and compliance with regulations. In her current role at Calyx, she leads a team of Regulatory Consultants who provide strategic regulatory input into the RIM software development lifecycle and supports clients with their subject matter expertise to effectively manage complex regulatory processes, in alignment with the changing regulatory landscape.
Karen is a member of the IDMP/SPOR Task Force within the PMS group in addition to participating in several working groups including SPOR PMS, IRISS and a Focus Group for Process looking at the TOM for step 1.
Product Marketing Director, RIM, Calyx (Moderator)
Amy Williams has nearly 15 years of experience working within Regulatory Affairs across various roles. As the Product Marketing Director for RIM at Calyx, she works closely with RIM delivery and client enablement, while supporting the product, marketing, and commercial organizations. She is driven by understanding the current challenges and needs of the regulatory industry and how Calyx can alleviate these. Amy worked with Kelly and Laurent on the EMA Task Force at its inauguration in 2015. As the industry nominated co-lead for the S&P subgroup at that time she was deeply involved in the initial discussions and today she remains passionate about IDMP’s success and convinced of the instigation for positive change it can promote throughout the industry.
Principal, K2 Consulting
Kelly Hnat is a leader in RIM and IDMP with 25 years experience in the biopharmaceutical industry-leading IT, RIM, and Regulatory Operations organizations. Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS subteam, and the SPOR EU Implementation Guide Focus Groups. Additionally, she is a member of ISO TC215/WG6 (the ISO group responsible for the IDMP standards), a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards. Kelly is the founder of K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.
Business System Owner, XEVMPD / IDMP, MSD
Laurent Desqueper has worked in the pharmaceutical domain for nearly 20 years. Laurent started with consultancy services to the EMA, including eCTD, EU Module 1, ICSRs and E2B(R3) in ICH, as well as Telematics programs like RDM, the electronic Application Form or PIM. In 2012, Laurent joined Merck Sharp & Dohme (MSD) to implement XEVMPD/Article 57 within the company, as a standalone solution first, and within Liquent InSight since 2019. Laurent is also active within industry trade associations (EuropaBio and EFPIA), and has been the Industry Chair of the IDMP/SPOR Task Force since September 2018. A member of several working groups including IDMP/SPOR PMS and DADI, Laurent is committed to the business digital transformation of the pharmaceutical sector.