Pharmacovigilance professionals in pharma and biotech face the continuous challenge of balancing patient safety with ensuring patient access to medicinal products. Risk Management Plans (RMPs) and Risk Minimisation Measures (RMMs) play a critical role in enabling and maintaining a favourable benefit-risk ratio.
RMPs must be implemented within specific timelines and remain inspection ready. However, as living documents, they require continual updates and adaptation to emerging risks, ongoing completion of pharmacovigilance activities and the seamless integration of RMMs. Navigating these demands can be challenging, particularly within the constraints of local health systems and the expectations of healthcare professionals and their patients.
Join us to learn about practical solutions and advanced technologies to enhance your ability to efficiently monitor and respond to risks, ensure regulatory compliance, improve decision-making, and ultimately safeguard public health.
- Learn how to adapt and apply RMPs effectively across diverse healthcare systems, while addressing the needs of healthcare professionals and patients.
- Discover how to leverage digital tools and platforms to enhance RMP monitoring and implementation
- Review the key methods to measure and monitor RMP/RMM effectiveness
- Learn how PV leadership, EU QPPV and LPPV can maintain appropriate oversight
Register today for insights and knowledge to help you effectively navigate the digital transformation in pharmacovigilance.
Audience
- Pharmacovigilance
- Risk Management
- Drug Safety
- Regulatory Affairs
- Quality Assurance
- Medical Information
- Data Analysts
- Medical Reviewer
Speakers
Steve Bowers
Steve Bowers serves as a Director in the PV Specialised Services team at ICON, bringing over two decades of experience in pharmacovigilance across industry and CRO sectors. His expertise lies in risk management and aggregate safety services.
Rakan Bitar
Rakan Bitar has over a decade of experience in the pharmaceutical industry, specialising in patient safety and risk management. He is dedicated to bringing digital innovation to drug safety and clinical development and is a passionate advocate for automation in these areas.