Regulatory Governance (REGx)
Regulatory CMC collaboration for innovation in regulatory science.
REGx has developed from BioPhorum’s regulatory team as a program of work to enable cross-phorum discussions. It aims to connect internal technical and regulatory discussions that may not happen outside the BioPhorum collaboration, strengthening internal alignment in our member organizations.
Our aims include:
- To act as the one voice of the industry to enable the delivery of the industry’s technical changes rapidly and effectively
- To lead innovation in regulatory science through a team of regulatory experts who have the capability and credibility to create consensus and ultimately drive real change that enables patient’s access to our most innovative medicines
- To collaborate with other industry groups, standard organizations and regulators to make the BioPhorum positions the new standard of industry
BioPhorum’s unique ability is to link technical and regulatory innovation though professional and dedicated facilitation to make the journey to innovation better and faster. A single organization cannot change the regulatory framework, our team can and has.
Tangible industry consensus positions
We manage technical and regulatory experts to ensure the delivery of a tangible industry consensus position, enabling cross-phorum discussions through our core setup. And we ensure regulatory aspects are considered in parallel with scientific interests.
We interact directly with regulators, pharmacopoeias, standard organizations and other industry groups and, where relevant, set up memorandums of understanding and non-disclosure agreements. We facilitate the assessment of the most relevant partners to move from BioPhorum positions to industry standards.
We have connected internal technical and regulatory discussions that may not happen outside the BioPhorum collaboration, strengthening internal alignment in our member organizations.
We have touchpoints with members across the different phorums (including business development, phorum directors and account managers) for a clear communication path for the best regulatory alignment and support at all stages.
Regulatory Governance (REGx) deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.