Overcoming Regulatory Challenges in Africa
Insights to Support Successful Market Entry/Expansion
Tuesday, December 11th - 10:00 EST | 15:00 GMT | 16:00 CET

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What topics will be discussed?

With chemistry, manufacturing and controls (CMC) activities comprising as much as 15% of R&D spend, companies can ill-afford to make a mistake. And when you consider that 1 out of 10 first-cycle regulatory reviews are rejected due to CMC-related issues, millions of dollars are potentially at risk. Add both of these points to specific challenges in African markets and the challenges are exponentially greater.

Join Clarivate’s Life Sciences experts for a review of regulatory challenges in Sub-Saharan African (SSA) and how to overcome them. During the meeting, they’ll provide tips and insights on how to:

  • Develop CMC strategies that balance cost, time, and risk
  • Efficiently track CMC requirements in SSA countries to ensure compliance with evolving regulations
  • Compare the countries that best fit your manufacturing, trial and distribution capabilities
  • Analyze the optimal path to market by pinpointing potential approval pathways

Position your drug for success and have greater confidence in your regulatory submissions.

1/10: https://jamanetwork.com/journals/jama/fullarticle/1817795
15%: 2018 CMR Factbook from Clarivate Analytics: Drawn from the 2018 R&D Investment Metrics Programme

Shyama Ghosh, Molecular Biologist and Senior Science Editor

  • Shyama received her Ph.D. from the Vrije Universiteit Brussels, Belgium
  • Experience in vaccine studies and host-parasite interactions in the field of infectious diseases

Stephen DuPraw, Managing Editor

  • Stephen is managing editor of the Incidence and Prevalence Database (IPD)
  • Stephen also manages content and production for Disease Forecasts, Clarivate’s customizable forecasting reports, as well as Disease Briefings.

John Cleverley, Product Manager, Life Sciences

  • John has nearly 15 years of industry experience
  • Worked as a senior editor and Manager on the Cortellis Competitive Intelligence forecast drugs content database

Event details

  • Date Tuesday, December 11th
  • Time 10:00 EST | 15:00 GMT | 16:00 CET

Who should attend?

  • Regulatory Affairs Professionals
  • CMC Quality and Compliance Professionals
  • Business Development and Licensing Professionals
  • Clinical Operations Professionals