White paper

Medical Writing in Drug Safety

Medical Writing in Drug Safety

Update your PV writing skills
Author: Dr Tiziana von Bruchhausen

Are you looking to improve your pharmacovigilance writing skills and stay up to date with the latest industry standards?

Read our whitepaper, 'Medical Writing in Pharmacovigilance' for a concise overview of the essential documents you’ll need to master, including Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs). Learn about the key success factors for creating and maintaining high-quality safety reports and get valuable insights from industry expert Dr. Tiziana von Bruchhausen.
 
For more in-depth training on these topics, join our online course “Medical Writing in Pharmacovigilance”, where you can learn from Dr Tiziana von Bruchhausen and gain hands-on experience in writing DSURs, PSURs, and RMPs.

Download now the white paper 'Medical Writing in Pharmacovigilance'.

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Medical Writing in Drug Safety

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Events for „Pharmacovigilance“

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Qualification Course: Head of Pharmacovigilance

Combined offer of three compulsory seminars plus one elective module for (future) Heads of the Pharmacovigilance Department - learn the responsibilities and legal aspects of managing a PV system and its staff, and select an elective module according to your individual interests.

online 01/01/-31/12/2025
Qualification Course: Qualified Person for Pharmacovigilance (QPPV)

Combination of three selected seminars - with this qualification course, you will first gain insight into the legal aspects and general responsibilities of the Qualified Person for Pharmacovigilance (QPPV). You will then deepen your professional and practical knowledge to perform your role more effectively.

online 01/01/-31/12/2025
An Introduction for Pharmacovigilance Managers

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Take the next step in your professional growth - enrol now!

online 20 - 21/10/2025
online 24-25/03/2026
Pharmacovigilance Auditing

Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!

online 27 - 28/10/2025
Global Pharmacovigilance Requirements

Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in five consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!

online 18 - 19/11/2025
Advanced class: The Global Network of Local and Regional QPPVs

Are you a QPPV, local Safety Officer, or part of a QPPV office within an international MAH? Looking for a targeted training course to improve your day-to-day activities and collaboration with other PV professionals? This seminar shows you how.

online 11/12/2025
The EU Qualified Person for Pharmacovigilance (EU QPPV)

This two-day course equips new or in future QPPVs with the fundamentals of EU pharmacovigilance legislation, QPPV responsibilities, and strategic planning. Learn what it takes to fulfil the role, ensure compliance, and build your roadmap to QPPV readiness. Ideal for aspiring QPPVs or those preparing future candidates. Secure your place today!

online 13 - 14/01/2026
Artificial Intelligence in Pharmacovigilance

Join our interactive course to explore how AI is transforming pharmacovigilance. Take part in discussions, hands-on workshops, and case studies while diving into AI technologies, regulations, and their applications in drug safety. Register now to participate, share insights, and collaborate with peers!

online 19/01/2026
Toxicology and beyond: Safety assessment in drug development

During our online training "Toxicology and beyond: Safety assessment in drug development" you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.

online 02 - 03/02/2026
Global Pharmacovigilance Inspection Readiness

Learn how to prepare your pharmacovigilance system in Germany, Europe and worldwide for an upcoming inspection in this one-day online course. Gain a comprehensive understanding of the EMA's Good Pharmacovigilance Practice (GVP/GPvP) modules, strategic and remote planning and preparation, and differences in GVP inspections around the world.

online 02/02/2026
Medical Writing in Pharmacovigilance

Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, you will gain a comprehensive understanding of the regulatory requirements and hands-on experience in crafting and maintaining PSUR, RMP, and DSUR. Learn best practices, avoid common pitfalls, and address global challenges to become a proficient "Pharmacovigilance Writer"!

online 04 - 11/03/2026