Interaction with Health Authorities
Newly launching for 2024, exploring how industry interacts with health authorities is a key priority area for our members to collaborate on. As new modalities and technologies emerge from the R&D pipeline, knowledge, processes, and policies fit approve these innovations can be unclear, leading to many queries and time lags. Improved interactions between innovators and regulatory bodies would be of benefit to all but key is preserving the autonomous role of regulatory bodies in patient safety. BioPhorum has a long history of bringing together different stakeholders in a safe environment to foster improved ways of working that ultimately aids patient access to new treatments.
Bringing experts together
- Exploring mechanisms to work with regulators at an earlier stage prior to submission, bridging the gap between organisations during CMC
- Socializing deliverables from across BioPhorum with regulators to advance regulatory innovation across the ecosystem
- Working with national and regional regulatory bodies to understand specific regional needs yet look to harmonize filing approaches where possible;
Improved ways of working
- Allows a greater understanding and improved ways of working should lead to fewer queries and pushbacks benefiting regulatory professionals based in industry and regulators alike
- Using collective knowledge and improved understanding of biopharmaceutical CMC should enable faster patient access while ensuring safety remains paramount.
Interaction with Health Authorities 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.
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