We are offering 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). Longer modules are usually broken down into several shorter sessions. Two or more modules can be combined, integrated and expanded on to form a longer course (to be delivered as a series of one- to two-hour seminar modules).

All topics shown below are currently available for remote in-house sessions. Pricing will depend on the number of training sessions and the extent of collaborative customization. Clients may record sessions and will be provided a copy the training slide decks for internal use.

First modules for remote public training are expected to be rolled out beginning in April-May 2021. They will be advertised in LinkedIn.

Current list of training modules:

• Labeling essentials for PV professionals involved in drug development - DCSI, EU-RSI and more (approx. 5 hours)
• Adverse reactions for purposes of labeling versus identified/potential risks for RMP/DSUR (approx. 5 hours)
• Harmonizing safety labeling of older products - Dos and don’ts (approx. 2 hours)
• Effective justifications for postmarketing safety labeling changes (approx. 2 hours)
• Labeling process and implementation tracking for safety labeling changes (approx. 3 hours)
• Business rules and documentation for safety labeling implementation (approx. 2 hours)
• Adding adverse reactions to CCSI and local labeling - Regulatory labeling expectations (approx. 5 hours)
• Adding interactions and lab test interferences to core and local labeling - Regulatory labeling expectations (approx. 5 hours)
• 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