Regulatory Interaction

Our aim is to enable engagement and alignment with Regulatory Stakeholders, in order to accelerate adoption and successful implementation of advances in manufacturing across all BPOG Phorums and Workstreams.


The BioPharma 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 BPOG Regulatory Interaction Team provides 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, across the regulatory networks of member companies.


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.


The Regulatory Interaction team consists of around 40 representatives from 30 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 BPOG phorums with appropriate Regulatory background and experience.

 Latest News:

Click here to read the latest Regulatory Interaction news


Member experiences

The Benefits. Explained

Download the video here (MP4 format)

The benefits of BPOG.

Download the video here (MP4 format)

Evolving and improving

Download the video here (MP4 format)

Benefits of Ask BPOG

Download the video here (MP4 format)

Making change happen

Download the video here (MP4 format)

Be part of the BPOG community

Download the video here (MP4 format)

The value of BPOG

Over the last few years, our phorums have become the place of choice for many companies in the biopharma industry to CONNECT and make benchmarking live and interactive.

By submitting this form, you are consenting to receive marketing emails from: BioPhorum, 5 Westbrook Court, South Yorkshire, S11 8YZ, You can revoke your consent to receive emails at any time by using the SafeUnsubscribe® link, found at the bottom of every email. Emails are serviced by Constant Contact