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How Pharmacovigilance Keeps MS Therapies Safe: From Drug Development to Real-World Monitoring (with Dr. Nora Möhn)
Description
How safe are MS therapies? And how do we actually know?
In this episode, neurologist Dr. Nora Möhn explains the concept of pharmacovigilance — the continuous monitoring of drug safety from early development through approval and real-world use.
This conversation was originally published in September 2023 on the German MS-Perspektive podcast. For this English edition, regulatory references and country-specific details have been carefully adapted to reflect internationally relevant systems and resources. The medical content remains fully up to date.
You will learn:
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What pharmacovigilance means and why it is essential for people with MS
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How safety data is collected in Phase I–IV clinical trials
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How rare side effects are detected after market approval
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How neurologists assess the benefit-risk profile of MS therapies
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What special considerations apply during pregnancy, in children/adolescents, and in older patients
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How patients can report suspected side effects in different countries
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Why ongoing monitoring builds trust and treatment confidence
A well-monitored therapy not only slows down MS — it enables long-term safety, confidence, and self-determined living.
🔗 Read the full article here: https://ms-perspektive.de//en/154-pharmacovigilance
🌍 International Pharmacovigilance Reporting SystemsIf you would like to report suspected side effects, you can contact your national medicines authority. Here are official resources:
European Union European Medicines Agency (EMA) – EudraVigilance https://www.adrreports.eu https://www.ema.europa.eu
United States FDA MedWatch Program https://www.fda.gov/medwatch https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
United Kingdom MHRA Yellow Card Scheme https://yellowcard.mhra.gov.uk
Canada Health Canada – Canada Vigilance Program https://www.canada.ca/en/health