On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2) format. Click here for the story, here for our most recent paper discussing the topic, or here to contact us for help with any pharmacovigilance issues you may have.
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- Home
- Services
- Pharmaceutical Consulting Services
- Strategic Drug Development
- Strategic Drug Development Services
- Pharmaceutical Development Programs: Implementation and Oversight
- Pre-IND Meetings
- Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)
- Clinical Trial Design
- Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2)
- 505(b)(2) NDAs
- Generic Drugs: 505(j) ANDAs and Potential Diversification
- Nonprescription Drugs (OTC)
- Medical Device Consulting
- Post-Launch Activities
- Specialty Services
- Regulatory Updates
- About PDG
- Regulatory Resources
- Contact PDG
EMA to Launch New Version of EudraVigilance
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