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Informa

24 - 26 April 2018
SANA Lisboa Hotel,
Lisbon

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

Thank you to everyone who attended this year's eRegulatory Summit

Conference 1 - Regulatory Information Management & IDMP Compliance; Conference 2 - Global eCTD Management; PLUS Filing Variations Symposium

Thank you for another successful year at the eRegulatory Summit


We would like to extend a very big thank you to everyone who attended this year's eRegulatory Summit. In Madrid, industry experts gathered to discuss the latest regulatory updates for Regulatory Information Management, IDMP, Global eCTD Management, and Filing Variations. It was great seeing so many familiar faces, as well as meeting lots of new ones. 

*COMING SOON* : Keep an eye out for the 2018 dates. We look forward to seeing you again next year!

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
Filing Variations Symposium
  • Implementing global variation strategies: What's working?
  • Navigating regulatory requirements in Brazil
  • Grouping and worksharing initiatives: Industry benchmarking
  • Quality documentation: What are regulatory authority expectations?
  • Regulation 712/2012: Sharing experiences and challenges

2017 Stats: Connecting the Regulatory Community

190+
Regulatory Affairs, RIM, IDMP, Submissions, Documentation, Publishing, Regulatory Operations, IT, and Systems Experts
120+
Leading Pharmaceutical Companies Represented Including Roche, Bayer, Sanofi, GSK, AstraZeneca and Many More
60+
Influential Speakers Provide Regulatory Guidance and Practical Industry Feedback

Free On-Demand Webinar with Andrew Marr

Hear from Andrew P Marr for direct feedback and take away messages surrounding IDMP implementation:

  • Clarifying the current status and timelines for IDMP
  • Discussing the latest priorities and updates from the EMA
  • Exploring how companies are preparing for IDMP implementation
  • Outlining how the updated IDMP timelines can be leveraged to improve business operations

Andrew P Marr, Managing Director, Marr Consultancy Ltd., UK

Click here to download the webinar slides 

Please note the slides available for download have been updated slightly since the live webinar recording.

Pharmaceutical Training International | PTI


PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We deliver CPD certified training on a wide range of topics including R&D, pre-clinical, clinical, manufacturing, regulatory affairs, pharmacovigilance, biotech, business strategy and soft skills. Our courses are delivered in a variety of formats such as public face-to-face, customised in-house, webinars, eBooks and online academies.