€484

Breaking down the silos: Product Development Journey through Post-Marketing...

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Location

Oracle Office

José Echegaray, 6B, 28232 Las Rozas de Madrid

Madrid

Spain

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Refund Policy

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Refunds up to 7 days before event

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BREAKING DOWN THE SILOS Product Development Journey through Post-Marketing : EMA vs FDA

DAY 1: Thursday, October 10th

9:30 - 10:00 Registration and Welcome Coffee
10:00 - 10:30 Introduction and Host Presentations
10:30 - 13.00 Session #1 Comparison of EMA and FDA Regulatory Landscape in Clinical Trials

  • Introduction to FDA and EU Regulatory Activities for Drug Development and Clinical Trials
  • Integrated Summaries: Strategies for Meeting Regulatory Challenges
  • Pre-Marketing Safety Reporting & Signal Detection

13:00 - 14:00 Lunch Break
14:00 - 16:30 Session #2 Post-Market Regulatory

  • Comparison of US vs EU regulations, procedures, requirements, practical examples and submission format
  • Are you ready for your next Pharmacovigilance audit? PhV compliance and QMS for Sponsors
  • Surveillance and Safety Obligations after approval

*Light coffee break foreseen during both sessions
19:00 Networking Dinner Event


DAY 2: Friday, October 11th

9:30 - 10:00 Welcome Coffee
10:00 - 12.30 Session #3 Impact of Technology on Regulatory and Vice Versa

  • The (R)evolution of Technology in the Pharmaceutical Sector
  • Digital Transformation in Clinical Trials: eClinical Selection and the Regulatory Impact
  • How AI and Cloud are Impacting Multivigilance

12:30 - 13:30 Lunch Break
13:30 - 15:00 Roundtable Discussions

  • Roundtable #1: Presentation and Discussion: Regulatory Challenges in the Industry: EU vs FDA, Brexit and Technology
  • Roundtable #2 The Future of Regulatory Affairs

*Light coffee break foreseen during both sessions

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Date and Time

Location

Oracle Office

José Echegaray, 6B, 28232 Las Rozas de Madrid

Madrid

Spain

View Map

Refund Policy

Refunds up to 7 days before event

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