Mastering RMPs and RMMs: Tech-driven solutions for patient safety

Life Sciences, Pharmaceutical Regulation, Drug Safety,
  • Thursday, September 12, 2024 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

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.

In this webinar, the attendees will get to learn about practical solutions and advanced technologies to enhance their ability to efficiently monitor and respond to risks, ensure regulatory compliance, improve decision-making and ultimately safeguard public health. They will also gain insights into:

  • How to adapt and apply RMPs effectively across diverse healthcare systems while addressing the needs of healthcare professionals and patients
  • How to leverage digital tools and platforms to enhance RMP monitoring and implementation
  • The key methods to measure and monitor RMP/RMM effectiveness
  • How pharmacovigilance leadership, EU Qualified Person Responsible for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV) can maintain appropriate oversight

Register for this webinar today for insights and knowledge that can help effectively navigate the digital transformation in pharmacovigilance.

Speakers

Steve Bowers, ICON

Steve Bowers, Director, Pharmacovigilance & Safety Services, ICON

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.

Message Presenter
Rakan Bitar, ICON

Rakan Bitar, Senior Director, Pharmacovigilance & Safety Services, ICON

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.

Message Presenter

Who Should Attend?

This webinar will appeal to senior professionals from biotech and large pharma companies involved in:

  • Pharmacovigilance
  • Risk management
  • Drug safety
  • Regulatory affairs
  • Quality assurance
  • Medical information
  • Data Analysts
  • Medical Reviewers

What You Will Learn

Attendees will learn about:

  • How to adapt and apply RMPs effectively across diverse healthcare systems while addressing the needs of healthcare professionals and patients
  • How to leverage digital tools and platforms to enhance RMP monitoring and implementation
  • The key methods to measure and monitor RMP/RMM effectiveness
  • How pharmacovigilance leadership, EU QPPV and LPPV can maintain appropriate oversight

Xtalks Partner

ICON

ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.

With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.

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