Stay up to date with the latest changes in pharmacovigilance guidance. This course provides a focused overview of key updates introduced in GVP Module XVI (Rev 3) and Addendum II, covering the latest regulatory expectations, best practices in designing and implementing risk minimisation measures, and implications for MAHs. Ideal for pharmacovigilance professionals looking to ensure compliance and enhance the effectiveness of RMMs in the EU.
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Key updates on GVP Module XVI Risk minimisation measures (Rev 3) and Module XVI Addendum II
About course
THIS COURSE INCLUDES
63 minutes of Video Content
60 minutes of Additional Learning Materials
Competence Test with 27 questions
Certificate after course completion
Course instructor
Karolina Wawrzyniak
Country Patient Safety ManagerAbout
I am Karolina Wawrzyniak and I am a Country Patient Safety Manager at pharmaceutical company. In my daily work I deal with the broadly understood risks associated with administration of a medicinal product and benefit/risk balance. For this reason, I mostly specialize in creating Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Benefit/Risk Analysis and Safety Monitorings. I prepare reports for both the European and Eurasian countries. Furthermore, I specialize in additional risk minimization measures (aRMMs). I take part in many projects related to aRMMs - plan, implement and supervise educational materials and programs (e.g Pregnancy Prevention Programme), coordinate projects related to the switch of the drug legal status, conduct trainings related to risk minimization, cooperate with healthcare professionals, representatives of Competent Authorities, opinion leaders, medical experts and contractors. Additionally, I supervise the processes related to Safety Data Exchange Agreement (SDEA), I cooperate with lawyers and many business partners around the world. Moreover, I am also active in the field of clinical trials – I prepare Development Safety Update Reports (DSURs), supervise the list of clinical and non-clinical trials and I am responsible for collecting and verification of documentation from clinical trials.
I graduated from the Medical University in Łódź in the field of Pharmacy. After 5.5 years of study, I did a six-month internship in community pharmacy, after which I became a Master of Pharmacy. My adventure with the PV department began with an internship in a pharmaceutical company, after which I got the position of a Specialist and then was promoted to the Senior PV Specialist. But already during college I participated in many courses in the field of Pharmacovigilance, Regulatory Affairs and Clinical Trials:
- Introduction to clinical trials
- Introduction to Pharmacovigilance
- Pharmacovigilance – Professional Level of Training
- Principles of Regulatory Affairs for medicinal products, veterinary products with elements of pharmacovigilance management & Documentation for medicinal and veterinary products
- Introduction to collecting and reporting adverse events in clinical research
- Data safety and monitoring boards for clinical trials
- Pharmacovigilance Specialist at Pharmaceutical Company
By attending this course, you will learn
- Explain the key updates introduced in GVP Module XVI Revision 3 and Addendum II and their implications for risk minimisation strategies
- Describe new terminology and classification of RMM
- Identify the regulatory expectations for designing, implementing, and evaluating additional risk minimisation measures (aRMMs) under the updated guidance
- Design effective implementation pathways and dissemination plans for additional risk minimisation measures, ensuring alignment with regulatory requirements and best practices
- Apply principles of effectiveness evaluation to assess the impact and success of RMMs in line with revised GVP guidance
- Evaluate the role of patient and healthcare professional involvement in the implementation and optimisation of aRMMs, including communication strategies and engagement methods
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