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Menu Back toComplimentary - A Pragmatic Way to Navigate the Safety-Regulatory Continuum for Mature Products

Complimentary - A Pragmatic Way to Navigate the Safety-Regulatory Continuum for Mature Products




This Solution Provider Webinar is brought to you
by DIA in cooperation with Sciformix Corporation

Today, in the face of dwindling drug pipelines, stringent drug regulations, and block-busters crossing their patent exclusivity, mature and established products offer an opportunity for companies to sustain their revenues and bottom lines in the increasingly challenging pharmaceutical market.

Compared to new products, mature products consume considerably less energies and resources for their maintenance and promotion. However, due to continually evolving regulations, and particularly the maturation of regulations in emerging markets, the requirements for data and documentation for all products, including the established ones, are substantial. Innovator and generic companies who sell the products must perform pharmacovigilance activities, maintain regulatory dossiers and labels, and conduct benefit-risk management so as to maintain their licenses. Global and efficiently structured multifunctional teams, either in-house or within service providers can manage these activities in an integrated manner, allowing companies to reduce costs while maintaining revenue, ensuring regulatory compliance and reducing risk. Furthermore, better use of technology and processes can optimize synergies between different teams, leading to better product value.

Featured topics

  • The importance of mature products
  • The safety continuum
  • The regulatory continuum
  • An integrated approach for managing mature products
  • Advantages of an integrated approach to mature product life cycle maintenance

Who should attend?

Professionals who work in the area of:

  • PV and Risk Management including safety/pharmacovigilance operations, aggregate reporting and signal detection
  • Regulatory Affairs
  • Quality Assurance and Audit
  • Medical Affairs
  • Clinical Development

Learning objectives

At the conclusion of this webinar, participants should be able to:

  • Recognize the importance of mature products and why their maintenance is a critical activity
  • Evaluate the advantages of an integrated approach as against a segregated approach
  • Employ innovative and cost-effective approaches that can help ensure patient safety and compliance while continuing to meet ever-increasing and complex regulatory demands

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