Regulatory
Overview
BioPhorum Regulatory CMC will launch in April 2023, bringing together CMC leaders who have a common goal – to improve access to medicines through innovation in the regulatory ecosystem.
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.
Benefits
Members include
Accelerating industry progress with the new BioPhorum Council
Accelerating industry progress with the new BioPhorum Council
BioPhorum’s Deliverables Report 2022 – all our content at your fingertips
Helping the ICH refine its guidance on analytical proceduresÂ
BioPhorum’s strategic framework shines a light on raw material management
BioPhorum’s Deliverables Report 2022 – all our content at your fingertips
Helping the ICH refine its guidance on analytical proceduresÂ
BioPhorum’s strategic framework shines a light on raw material management

workstreams

biomanufacturers suppliers
