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Medical Affairs Leaders Forum (Asia)

Singapore - July 20-21, 2016
Presentation

Navigating post-marketing requirements worldwide: What to anticipate as you move towards submission

Related topics: Pharmaceutical/Biotech, Medical Affairs & Stakeholder Engagement, Real-World Evidence & Late-Phase Research, Asia Pacific
Availability: FREE
  • Review of post-marketing requirements in the USA, Europe, and South Korea.
  • How to interpret the demand of the authorities,
  • Proactive planning to drive design.
  • Real-world case studies from the USA, Europe and South Korea.
Speaker

Alexandre Malouvier
Director of Scientific Affairs, Late Phase Services,
PRA Health Sciences

Presentation

Practical strategies for implementing RWE studies in Asia Pacific

Related topics: Pharmaceutical/Biotech, Medical Affairs & Stakeholder Engagement, Real-World Evidence & Late-Phase Research, Asia Pacific
Availability: FREE
  • Differences between real-world evidence studies and randomized controlled trials.
  • Asia Pacific country specific examples of real-world evidence studies.
  • Local regulations on study approval and execution.
  • KOL value and working with investigators in APAC.
Speakers

William Maier
Chief Scientific Officer, Mapi Group, UK

Isabelle Grau
Director, Real World Evidence APAC, Mapi Group, Australia