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We are currently creating a new series of remote training modules for pharmacovigilance professionals.
All modules will be available as remote public training sessions (for individual sign-up) and as remote in-house sessions (for groups of company employees; customized content if desired)

We expect to roll out first modules in March 2021. They will be advertised in LinkedIn.

Preliminary list of modules:

  • Labeling essentials for PV professionals involved in drug development - DCSI, EU-RSI and more
  • Adverse reactions for purposes of labeling versus identified/potential risks for RMP/DSUR
  • Harmonizing safety labeling of older products - Dos and don’ts
  • Effective justifications for postmarketing safety labeling changes
  • Labeling process and implementation tracking for safety labeling changes
  • Business rules and documentation for safety labeling implementation
  • Adding adverse reactions to CCSI and local labeling - Regulatory labeling expectations
  • Adding interactions and lab test interferences to core and local labeling - Regulatory labeling expectations
  • When to elevate risks to the Warnings and Precautions level? When to contraindicate?
  • MedDRA term grouping for labeling
  • The Adverse Reactions section in USA prescribing information - Demystified
  • The Undesirable Effects section in the EU SmPC - Demystified
  • US PI and EU SmPC - Commonalities and differences in safety content and underlying approaches