Regulatory risk and simplification

An effective regulatory environment is critical to ensuring patient safety. It is fundamental for physician and patient to trust in therapies, and therefore adopt new treatments. For our members, ensuring that all quality and regulatory requirements are met and license to operate is never at risk, is an absolute priority.

However the regulatory environment is challenging and complex, particularly in a rapidly evolving technological landscape, with a broad range of national regulatory bodies globally. Regulatory professionals need to comply with ever-increasing and dynamic requirements at a global scale. This impacts approvals, time to market and, ultimately, patient access to innovative new treatments and therapies.

Since its first Phorum in 2008, many BioPhorum teams have focused on addressing regulatory and quality compliance opportunities for simplification and improvement. Our members report that the impacts from these efforts have been very significant. It has also been amplified, through our engagement with regulators and other influential bodies. Regulatory-focused workstreams across Phorums therefore remain a major part of the work today.

It is increasingly clear that organizations also need to adapt to the increasing pressures of data-driven regulations through their own data and digitization strategy, and to work with regulators to address specific challenges with advanced therapies. This presents an opportunity to work together and present a single industry vision for harmonized approvals.

Our members in BioPhorum Regulatory CMC have therefore defined a higher level goal of creating “one product, one dossier, one submission, one review, one approval” across the global regulatory environment.

BioPhorum’s work within regulatory risk and simplification is already helping to create solutions to the benefit of all along the supply chain. We will continue to work together to streamline regulatory submissions, accelerate access to new treatments and transform the regulatory ecosystem in a way which benefits all.

Being part of the conversations that drive this change is essential for organizations wanting to be at the forefront of innovation.

BioPhorum success stories

Better product characterization and understanding, and regulatory agency understanding; ensuring novel therapies have the greatest opportunity to reach the patient.

An industry perspective on understanding AAV capsid content variants
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Establishing a standard approach could cut product submission timelines and diminish the risk of a regulatory finding.
Potential to deliver an annual saving of between $0.5m and $1m per shipping solution, as well as a 50% reduction in resource requirements.

Best practice on transport qualification
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New government decree based on collaborative efforts with BioPhorum. Consultation ongoing to approve these new regulations, to cut time taken to approve post approval changes.
Through this work, time taken to market has been reduced to 6 – 12 months.

Collaborative approach to update Colombian regulatory framework
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Get in touch

Get in touch with our team to discuss how your business can help reduce regulatory risk and drive simplification.

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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An industry perspective on understanding AAV capsid content variants
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EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
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The Drug Substance 2.0 Strategic Value Framework
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BioPhorum’s holistic approach to container closure integrity
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Digital Plant Maturity Model 3.0
NEWS
Inaugural BioPhorum Quality face to face – get involved
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
PODCAST
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
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A vision for the biopharmaceutical industry’s inbound supply chain
NEWS
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
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BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
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DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing