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25 - 27 April 2017
Hotel Meliá Avenida América,

Best Practice for RIM, Preparing for IDMP Compliance and Global eCTD Management

Thank you to everyone who attended this years conference

Watch the highlights from this year's event

A very big thank you to everyone who attended the 2016 event; it was great seeing so many familiar faces, as well as meeting lots of new ones. Relive the week in our highlights video, or if you couldn’t make it, see what you missed out on and hopefully we’ll see you next year.

Key Stats for 2016...

Hours of Networking
Sessions from Top Speakers

Networking Opportunities at the eRegulatory Summit

“VERY good presentations, a good variety, good discussions – I have gotten a boost from my colleagues in the industry” – Senior Submission Manager, Ferring Pharmaceuticals A/S

“Being focused on IDMP, the RIM conference has helped me tremendously to get the bigger picture” – Associate Director IT, BMS

“Great event, interesting and very forward-thinking topics” – Senior Manager, Biogen

“Very good speakers sharing their knowledge and experience with a total transparency” – Head of Regulatory Compliance and Data Management, GEURBET

Highlights for 2016 included

Regulatory Information Management 2016...
  • Case studies from Roche, Biogen Idec, Gilead, UCB, Merck, CSL Behring, Mylan and many more
  • Practical insight from J&J, Bristol-Myers Squibb, Janssen, CSL Behring and others
  • LEO Pharma A/S discuss how to break silos and make effective system integrations
  • Best strategies for implementing Master Data Management and the single source of truth
  • Explore how to solve IDMP challenges with a Master Data Governance approach Interactively share experiences and challenges with implementation of IDMP projects in our round table experience exchange
Global eCTD Management 2016...
  • Latest updates on EU Telematics including EU eCTD Module 1 v3.0, PSUR repository, electronic application forms, CESP/EMA Gateway and more
  • Join our interactive evening experience exchange on eCTD progress in key global regions
  • Latest developments and implications of eCTD v4.0 from Leigh Sandwell, PfizerBenefit from:
  • MHRA and Polish Office for Registration of Medicinal Products feedback
  • Practically develop successful global variation strategies
  • Explore grouping and worksharing strategies for filing variations under 712/2012 
Filing Variations 2016...
  • Feedback from the MHRA and Polish Office for Registration of Medicinal Products
  • Global progress towards eCTD including GCC, Australia and South Africa
  • EU regulatory agency feedback from Belgian AFMPS
  • 5 case studies on submission process optimisation from Bayer, Eisai, Bristol-Myers Squibb, Ferring Pharmaceuticals & Swedish Orphan BiovitrumRegulatory authority feedback and case studies for overcoming challenges presented by regulation 712/2012 and international post approval change requirements.
  • Best practice for filing variations related to product safety



Hotel Meliá Avenida América, Madrid

Calle de Juan Ignacio Luca de Tena, 3628027 Madrid, Spain


Tel: 914 232 400


The Meliá Avenida America is located a few minutes from the IFEMA exhibition centre, the Juan Carlos I Congress Centre, Madrid Barajas International Airport and the Castellana Avenue, and is in one of the busiest areas for corporate activity and urban growth in Madrid, making it the perfect choice for business and leisure travellers, thanks to its extensive and comfortable facilities and the quality of its services.


Completely renovated in 2011, the hotel provides a spa, a full wellness centre, gym, a magnificent terrace, and a spectacular Convention Centre measuring 5,000 m2 with 32 rooms, all with natural light and capacity for up to 1,000 people.

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.