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eRegulatory Summit

25 April 2017

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

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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

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Venue

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