On-Demand Webinar

2019 global regulatory trends and outlook

Sarah Hardison, PhD
Head of Regulatory & Pharmacovigilance Solutions
Clarivate Analytics

Global Regulatory Outlook and Regional Trends

Increased R&D productivity in biotech and pharma means more drugs are being evaluated by health authorities and launched in world markets, with 2018 seeing the highest ever number of FDA new drug approvals. Shifting priorities in global pharma pipelines to rare diseases and advances in drug technologies means regulators are evolving guidelines to evaluate more drugs with less data to find meaningful, cost-effective therapies for patients in need. To understand the current landscape, this presentation will examine global and regional trends in:

  • Global harmonization and convergence
  • Patient engagement and real-world data
  • Bridging the gap between HTA and regulatory
  • Next-generation biologics manufacturing
  • Generics and biosimilars

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