Continuing Education credits are not available for On Demand Webinars
Broadcast time: 1 hour 16 minutes

Biopharmaceutical companies face an increasingly complex environment for their portfolios of older, marketed products, also known as established products. Governments and payers are scaling back reimbursement and demanding proof of value, while regulators are demanding more information and greater data consistency. New regulations are introducing increased complexity for maintaining marketed products, (e.g., EU GVP requirements for proactive and ongoing benefit-risk assessments and identification of medicinal products (IDMP)). In addition, emerging markets are demanding increased regulatory documentation.

As a result of these challenges, numerous large biopharmaceutical companies have considered selling off their portfolios marketed products. Companies electing to keep these products must maintain their licenses by performing pharmacovigilance, regulatory dossier/label maintenance, and benefit-risk management. Globalized organizational models are needed to manage and integrate these safety and regulatory activities. The goal is to maintain revenue and reduce costs while ensuring regulatory compliance and reducing risk.

This webinar will discuss the challenges with the current approach to managing safety, regulatory affairs, and benefit-risk activities within biopharmaceutical companies.  The speakers will explain how better use of technology and the integration of operations and processes can optimize synergies between pharmacovigilance, benefit-risk management, and regulatory life cycle maintenance, leading to better product value.