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.

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team members

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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.

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