BioPhorum Regulatory CMC
As regulatory professionals navigate a complex tapestry of evolving requirements on a global scale, our goal is to harmonize approvals, envisioning a future of “one product, one dossier, one submission, one review, one approval.”
The regulatory ecosystem, transitioning from static, paper-based processes, is at an inflection point as it adapts to the digital age. Regulatory bodies are shifting towards a data-driven approach, compelling life sciences organizations to swiftly adapt and devise their own digitalization strategies, led by the collective expertise of you, the industry experts our esteemed members.
Become a member and experience a collaborative platform where members, under the guidance and leadership of industry experts, actively shape and drive change. Our Phorum supports industry leaders in crafting innovation strategies, fostering a unified industry voice, and aligning towards a harmonized future. Our collaborative ambition is to reduce approval timelines, enhance interactions with health authorities, and advance towards more inclusive representation of the biomanufacturing ecosystem for the benefit of all patients.
The biopharmaceutical industry is working at the forefront of novel treatments and therapies but with the dominance of small molecules, ensuring that their voice is heard and considered when regulations are updated and adapted remains a challenge. Moreover, the regulatory approval process itself is outdated, cumbersome and sorely in need of change to embrace the digital revolution.
To address these challenges, our Phorum members have identified three key strategic objectives that guide our work:
Harmonization: one product, one standard, one submission, one review
Globally harmonized approvals process and standards offers the biggest impact in reducing time to market and getting essential medicines to patients as quickly as possible. Patients should be able to obtain access to life saving medicines quickly and safely no matter where they reside in the world. The COVID-19 pandemic illustrated this is an achievable goal to strive for. Our members collaborate with a variety of different stakeholders to advance work in harmonization efforts.
Interacting and engaging with health authorities
Health authorities, standards bodies and local agencies are all key stakeholders in the regulatory approvals process. With so many new innovations and modalities on the horizon, it is clear they need to update their approaches to further patient access, unlocking the expert knowledge inherent in the biopharmaceutical sector for the mutual benefit to all. Establishing effective ways of collaborating with health authorities whilst respecting their autonomy and critical role in patient safety is a key challenge our members are coming together on.
Transformation and digitization
Data-driven ways of working are permeating the biopharmaceutical manufacturing industry at pace. Yet regulators are only beginning to embrace this, leading to different rates of maturity, understanding and adoption worldwide. Moreover, a digital and data-driven regulatory dossier would do much to support the one dossier approach so key to harmonization efforts. The landscape is at present confusing and chaotic, our members are striving to use their collective knowledge to establish a roadmap for the future.
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