Newly launching for 2024, our members have identified a key gap in regulatory intelligence for biopharmaceuticals. Much of the current sharing of regulatory intelligence is dominated by small molecules and clinical information, with large molecules and CMC being overlooked: this presents a challenge to regulatory professionals in these fields with almost nowhere to go to seek insight. Approvals in biologics have been growing and with it, a need to understand the rapidly changing regulatory landscape, processes and policies to navigate global markets successfully.
Our members will be coming together to launch a new workstream
- Share experience and good practice in submissions for different modalities on a global scale
- Discuss where there are challenges and working together to produce new tools or processes to mitigate for these
- Identify gaps that are underserved and working with external stakeholders to surface these within the regulatory ecosystem
Understanding the rapidly changing landscape
Expected benefits will be:
- High quality biopharmaceutical CMC intelligence will allow regulatory professionals to strategize their filings better on a global scale;
- Understanding where there have been pushbacks or queries from regulators will allow for more robust filings, accelerating speed to market
- A deeper understanding of differences or gaps worldwide will allow our members to pivot their strategy accordingly
Regulatory Intelligence 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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