Author: Dr Tiziana von Bruchhausen
The main success factors for medical writing as a whole also apply to the requirements for writing PV documents. This checklist reduces the error and defect rate enormously. You will also get an insight of the growing requirements for the work of pharmacovigilance.
Download now the white paper 'Medical Writing in Pharmacovigilance'.
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!
Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth understanding of AI technologies, regulatory requirements, and practical applications in drug safety. Through expert insights and hands-on workshops, you'll learn how to leverage AI to enhance your pharmacovigilance processes. Register now to future-proof your PV operations.
This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!
Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.
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.
Reporting adverse drug reactions forms the foundation of drug safety. In this one-day online seminar, you will learn the regulatory requirements and best practices for ICSR reporting. Whether you are new to the topic or looking for a refresher, you will benefit from the extensive practical experience of our speakers from both Big Pharma and consulting!
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. Reserve your seat in our virtual seminar room.
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. Book now!
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"!
Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth understanding of AI technologies, regulatory requirements, and practical applications in drug safety. Through expert insights and hands-on workshops, you'll learn how to leverage AI to enhance your pharmacovigilance processes. Register now to future-proof your PV operations.