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Global Pharmaceutical Regulatory Affairs Summit
21-23 October 2025
Hotel Palace BerlinBerlin, DE
21-23 October 2025
Hotel Palace Berlin,
Berlin, DE

Avoid wasting time and resources. Industry leaders guide you through submissions in Asia Pacific, LATAM, Russia and CIS

Providing you with the most up to date global information

Day 1: Russia and CIS

  • Get to grips with Russian GMP inspections
  • Immerse yourself in labelling requirements
  • Clarify best practices for filing new registrations and CMC variations
  • Examine best strategies for product registration in Ukraine and Moldova
  • Rub shoulders with leading Pharma companies Bayer, GSK and Pfizer

Day 2: Latin America

  • Discuss latest ANVISA regulatory updates and expectations with AbbVie
  • Wrestle with the regulatory environments in Mexico and Argentina with Chiesi Farmaceutici
  • Traverse expedited approval pathways in LATAM with GlaxoSmithKline
  • Have you grasped the requirements for clinical trial submissions? Let us help!
  • Gain a comprehensive understanding of pharmacovigilance and risk management activities

Day 3: Asia Pacific

  • Comply with the rapidly evolving regulatory landscape in China through guidance from Biotest Pharmaceuticals
  • Get the know-how on the latest regulatory updates in the ASEAN countries from Roche
  • Examine the orphan drug designation requirements and expectations in Japan with Alexion Pharma
  • Dive into the regulatory requirements for labelling and package inserts across APAC with Sandoz
  • Unwrap market authorisations and latest regulatory updates in India with help from Tillotts Pharma