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Pharmacovigilance management

Everything from a single source

We monitor the safety of your medicinal products and support you in fulfilling your regulatory obligations – powerful and service-oriented.

Pharmacovigilance management

Pharmacovigilance is an umbrella term for all activities associated with monitoring the safety of medicinal products or serving to detect and avert medicinal product risks during the clinical trial phase and after marketing authorisation.

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems and risks.

In recent years, the regulatory requirements placed on marketing authorisation holders in the field of pharmacovigilance have increased significantly at both European and national level. Accordingly, over the past 20 years we have continuously expanded our pharmacovigilance service portfolio in order to support you efficiently in fulfilling your obligations.

>100 Pheda accounts (MAHs and CROs)
>900 Active substances in the weekly literature research
>200 Signal detection reports (Signal Sentinel®)
>100 PSURs
>20 Years of PV experience
>200 Clients
Case Study

Case Studies from Practice

How our pharmacovigilance tools make a difference in day-to-day work – two systems that ease the workload for MAHs and CROs.

Case Study

Pheda – Your PV Database

Shared, validated database server for the structured management of adverse event reports.

  • Shared SQL database server with company-specific database areas
  • Modern, E2B(R3)-compliant system validated to the GAMP 5 standard
  • Software-as-a-Service
  • Independent, structured management of adverse event reports (ICSRs / SUSARs)
  • Basic and Professional versions
Case Study

PhedaLit – digital & validated

Heacon's own validated literature database with client-specific presentation of literature citations.

  • Heacon's own validated literature database
  • Client-specific presentation of literature citations
  • Automatic digital notification when new entries are added
  • Chemically defined, herbal and homeopathic active substances for human and veterinary medicinal products

We look forward to getting to know you.

Do you have questions about our pharmacovigilance services? Get in touch with us – we would be glad to advise you personally.

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