eRegulatory Summit

25 April 2017

Connecting RIM, IDMP and eCTD professionals to drive regulatory strategies through authority access and industry expertise.

Learn From Senior Specialists in RIM, IDMP and Global eCTD!

Conference 1: Regulatory Information Management & IDMP Compliance

  • Ensuring high quality data: effective cleaning strategies
  • Integrating CMC changes into RIM systems
  • Working across departments to create end-to-end RIM processes
  • Implementing RIM projects in SME companies
  • IDMP implementation updates plus Master Data Management

Conference 2: Global eCTD Management

  • Progress in the GCC, South Africa, Thailand, China and CIS countries
  • EMA Policy 0070: How will this impact industry?
  • eCTD v4.0: Latest developments, practicalities and implications
  • Changes related to eAF and CESSP as of April 2017
  • Regulatory agency feedback from Oman, Spain, Belgium and Finland

Keynote Presentation

Overcoming the challenges of implementing a RIM System

  • Key factors for establishing the business case for successfully manage the regulatory information
  • Change management, transition and Go live
  • Business challenges namely:
    • Managing multiple common Quality Processes across sites and geographies
    • Standardize Data and enforce those standards

26th April at 12:00 by Rawan Musleh, RIMS Specialist, Hikma Pharmaceuticals


Hotel Meliá Avenida América
Calle de Juan Ignacio Luca de Tena, 36
Madrid 28027, Spain