Regulatory risk and simplification
An effective regulatory environment is critical to ensuring patient safety. It is fundamental for physician and patient to trust in therapies, and therefore adopt new treatments. For our members, ensuring that all quality and regulatory requirements are met and license to operate is never at risk, is an absolute priority.
However the regulatory environment is challenging and complex, particularly in a rapidly evolving technological landscape, with a broad range of national regulatory bodies globally. Regulatory professionals need to comply with ever-increasing and dynamic requirements at a global scale. This impacts approvals, time to market and, ultimately, patient access to innovative new treatments and therapies.
Since its first Phorum in 2008, many BioPhorum teams have focused on addressing regulatory and quality compliance opportunities for simplification and improvement. Our members report that the impacts from these efforts have been very significant. It has also been amplified, through our engagement with regulators and other influential bodies. Regulatory-focused workstreams across Phorums therefore remain a major part of the work today.
It is increasingly clear that organizations also need to adapt to the increasing pressures of data-driven regulations through their own data and digitization strategy, and to work with regulators to address specific challenges with advanced therapies. This presents an opportunity to work together and present a single industry vision for harmonized approvals.
Our members in BioPhorum Regulatory CMC have therefore defined a higher level goal of creating “one product, one dossier, one submission, one review, one approval” across the global regulatory environment.
BioPhorum’s work within regulatory risk and simplification is already helping to create solutions to the benefit of all along the supply chain. We will continue to work together to streamline regulatory submissions, accelerate access to new treatments and transform the regulatory ecosystem in a way which benefits all.
Being part of the conversations that drive this change is essential for organizations wanting to be at the forefront of innovation.
BioPhorum success stories
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Get in touch with our team to discuss how your business can help reduce regulatory risk and drive simplification.