The regulatory environment is challenging and complex, despite global efforts to harmonize and simplify. The quality of the product does not depend on where the patient is, but this is not reflected in the regulatory ecosystem today. This can have significant impact on regulatory approvals, time to market and ultimately, patient access to innovative new treatments and therapies.
Regulatory professionals must comply with an increasing and dynamic set of requirements, at global scale. More and more regulations are data-driven, which requires life sciences organizations to adapt at pace and to consider their own data and digitization strategy to support the industry vision and ambition for harmonized approvals (from divergence to convergence, aspiring to “one product, one dossier, one submission, one review, one approval”).
What can the Phorum do to address these challenges?
BioPhorum’s newest Phorum provides a dedicated space for members to focus on these priorities.
BioPhorum Regulatory CMC leads innovation and transformation in the regulatory ecosystem, driving the vision for ‘One product, one dossier, one submission, one review, one approval’.
Regulatory at BioPhorum
In addition to the latest Phorum launch, regulatory issues are receiving a further deep dive within our new program of work Regulatory Governance and External Partnerships (REGx). And at Phorum-specific level, there are workstream teams you can join as an existing member.
BioPhorum Regulatory CMC leads innovation and transformation in the regulatory ecosystem, driving the vision for ‘One product, one dossier, one submission, one review, one approval’. It provides a dedicated space for strategic leadership and a coordinated industry voice to move from divergence to convergence.
New program of work
REGx – Regulatory Governance and External Partnership
REGx has developed from BioPhorum’s regulatory team as a program of work to truly enable cross-phorum discussions through our core set up. It aims to connect internal technical and regulatory discussions that may not happen outside the BioPhorum collaboration, strengthening internal alignment in our member organizations.
Internal regulatory teams
Cell and Gene Therapy, Development Group and Drug Substance
These teams are Phorum-specific L2 and L3 technical workstream members, with a deep regulatory focus.
What can you do to get involved?
To be part of the journey to lead and drive innovation and transformation in Regulatory CMC, please complete this form.