Enabling Effective Medical Governance from Development to Post-marketing Surveillance
The concept and importance of Medical Governance is evolving in the industry. The emergence of the role of the Chief Medical Officer has driven the need for Medical Governance as the two are inextricably linked. The patient is at the core of this. The public, regulators and healthcare providers expect products to be safe and effective across the lifecycle from development to post-marketing surveillance and all the way through to product withdrawal. The overarching aim of Medical Governance will always be to protect the safety of those taking medicinal products as part of a clinical trial or as part of a treatment regime. However, when implemented properly, Medical Governance can also play a vital role to inform product development by advancing scientific and medical understanding.
An effective Medical Governance framework that is truly global is a vital component in meeting these needs. Without the application of medical standards that can be applied across the business, to partners and local markets, the expectations can never be met.
Top-level Medical Governance Challenges
Good medical science and ethical standards are consistently applied globally across the product lifecycle
governance bodies with clear remits and policies
Integrated technologies providing accurate, near real-time data from a multitude of sources
Compliant processes with well-defined escalation paths
We are in an era requiring R&D models that not only need internal multi-functional alignment beginning from the earliest phases of development, but also ongoing external engagement with stakeholders who are keen to understand the value of a product based on its benefit-risk profile relative to what is already on the market as well as what will be on the market.
Navitas Life Sciences Helps Sponsors Establish a Single Voice for Medical Decisions
At Navitas, we have worked with companies to ensure medical decisions are consistent throughout the business enabling them to approach external stakeholders with a single voice. From companies that are only in late stage development to those that have marketed products spread across divisions and multiple therapeutic areas, we can help you through this journey and make this change happen.
cmonet is the network for Chief Medical Officers to share insights, exchange ideas, and offer peer support. The founding group of CMOs, led by Mike Devoy of Bayer HealthCare, initiated the community given emergent expectations of the role from regulators and the diversity in scope and positioning of the role in the industry. For more information on cmonet, please click here.