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6th - 8th April 2022
★ 100% virtual conference ★Presented in Central European Time (CET)

6th - 8th April 2022
★ 100% virtual conference ★,
Presented in Central European Time (CET)

Thank you for joining us in 2021! Check back soon for more information on the 2022 event.

2021 Attendee

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Anonymous

The 2021 Global Pharmaceutical Regulatory Affairs Summit was very rich, and very well organized. The content very fruitful.

Do you have the need-to-know updates to ensure that your IDMP, eSubmissions, and global regulatory strategy is compliant and successful?

RIM & IDMP: There's no time to delay

  • IDMP is coming and this time it’s here to stay. Are you ready? Utilise 2021 to ensure you’re ready with feedback from 8 IDMP Taskforce members
  • Implementing IDMP on a time-crunch: Practical advice and preparing migration from XEVMPD
  • Discover the future of RIM: Data governance and best practices with Roche, Boeringer Ingelheim and Alexion

Regulatory Affairs in Global Markets: APAC, LATAM, MENA, EAEU & CIS

  • Trying to juggle global regulations? Put your questions to ANVISA, CECMED, CIRS, COFEPRIS, and Iraqi Ministry of Health 
  • Harmonisation and Submissions: Updates on Brazil, China, Colombia, India, Mexico, Russia, Turkey and more
  • How has COVID-19 affected the LATAM region? Hear how others have responded with case study examples 

eSubmissions and eCTD: Are you up to speed?

  • Get the scoop on the progression status of eCTD v4.0. in key markets and updates on processes from B.A.H., Gilead Sciences, and Takeda
  • IDMP & eCTD going hand in hand: what's the impact of data vs. documents? How can structure data affect submission process? Get the answers to these questions and more!
  • Dive into eCTD across the globe: Shared experiences for product registration and overcoming regional hurdles

Telematics: Putting the regulatory pieces together

  • Policy drives IT initiatives but does your IT framework much policy needs? Ensure cost-effective, efficient and Interoperability with updates from DKMA, Medicines for Europe and Industry
  • Hear how different IT Projects fit into the wider picture of policy to maximise your data and IT systems
  • Get ahead of the curve. Hear the latest updates from pilots and roadmaps for EPI and Clinical Trial Portals

Connecting the Global Pharmaceutical Industry, At the Touch of a Button

200+

Regulatory Professionals and Experts from Every Corner of the Industry

101

Companies Discussing Findings and Best Practices

78

Sessions Covering Critical Updates in the Pharmaceutical Regulatory Landscape

The News!

All articles below have been provided by Pink Sheet

EU Panel Outlines Practical Way Forward With Big Data

Woodcock: The US FDA Sets The Stage For Global Quality Dossiers

Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges

CONNECT WITH KEY BUYERS AT GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SUMMIT 2021

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.  

Contact Dylan Smith: DSmith@informaconnectls.com | +44 (0)20 3377 3237