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Critical Changes In Iris

NEWS | EMA Update Alert!

The European Medicines Agency has recently announced significant updates affecting pharmaceutical companies, especially concerning the management of Periodic Safety Update Reports (#PSURs) and referral procedures. These modifications are particularly crucial for Qualified Person for Pharmacovigilance (QPPV) roles, as they directly influence compliance and communication protocols.  Key Highlights:  IRIS Industry Manager Role: All Marketing Authorisation Holder (#MAH) product contacts must be kept current with the IRIS Industry Manager role. This ensures your company is updated and aligned with EMA regulations.  Centrally Authorised Products (#CAPs): For CAPs, only those authorized as a CAP Person should handle communications with the Medicines Agency. This

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