Regulatory
The biopharmaceutical industry continues to develop advanced best practice manufacturing processes, systems, technologies and facilities. However, we experience varying degrees of understanding and confidence across manufacturers and regulators. This can lead to uncertainty that proposed improvements will be accepted and successfully implemented in an aligned way. Therefore, to avoid perceived issues, best practice can end up being diluted, or solutions over-engineered. Ultimately, innovation and improvement is slowed, presenting a challenge to realize potential benefits such as speed to market, supply assurance and cost.
To address this, the BioPhorum Regulatory Governance Team recommends, facilitates and supports an ongoing platform of informal dialogue with agencies, offering industry views and listening to wider agency perspectives, prior to implementation. We are well placed to share industry positions on priority topics with agencies and solicit feedback by developing contacts with regulators and associated standard organizations, across the regulatory networks of member companies.
The FF mission is to develop and implement best practice processes in drug product operations.
FF collaborates to develop and implement safe, predictable, lean and agile processes in drug product operations that biopharmaceutical pipelines need now and into the future and has strong representation of the top sterile filling operations in the world, both drug manufacturers and CMOs.
The current FF collaboration program is targeting a number of transformational operational improvements. While some of these benefits are easy gains for members, they also recognize that in our regulated environment it makes sense to move together. For this reason, in many cases companies plan synchronized adoption to change the landscape that regulators see across the industry in one go.
workstreams
team members
biomanufacturers suppliers
Benefits
The goal of the team is to make appropriate regulatory agency connections, increase mutual understanding of key positions and challenges in implementing new biomanufacturing practices. The team is well positioned and resourced through pooled company intelligence of how different agencies are approaching key regulatory topics and challenges. This includes opportunities to share latest thinking with agencies with the desire to increase positive submission and inspection outcomes for both industry and regulators.
Members include:
The Regulatory Governance Team consists of 38 representatives from 26 biopharma manufacturing and supply partner companies. The representatives are experienced professionals with extensive regulatory background and extended networks within their companies, other industry groups and with regulators. Membership of the regulatory team is available to representatives from company members of Phorums with appropriate Regulatory background and experience.
