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