Regulatory support (REGx)

Regulatory CMC collaboration for innovation in regulatory science.

Truly cross-phorum

REGx has developed from BioPhorum’s regulatory team as a program of work to enable cross-phorum discussions. It aims to connect internal technical and regulatory discussions that may not happen outside the BioPhorum collaboration, strengthening internal alignment in our member organizations.

Our aims include:

  • To act as the one voice of the industry to enable the delivery of the industry’s technical changes rapidly and effectively
  • To lead innovation in regulatory science through a team of regulatory experts who have the capability and credibility to create consensus and ultimately drive real change that enables patient’s access to our most innovative medicines
  • To collaborate with other industry groups, standard organizations and regulators to make the BioPhorum positions the new standard of industry

Why collaborate?

BioPhorum’s unique ability is to link technical and regulatory innovation though professional and dedicated facilitation to make the journey to innovation better and faster. A single organization cannot change the regulatory framework, our team can and has.

Tangible industry consensus positions

We manage technical and regulatory experts to ensure the delivery of a tangible industry consensus position, enabling cross-phorum discussions through our core setup. And we ensure regulatory aspects are considered in parallel with scientific interests.

We interact directly with regulators, pharmacopoeias, standard organizations and other industry groups and, where relevant, set up memorandums of understanding and non-disclosure agreements. We facilitate the assessment of the most relevant partners to move from BioPhorum positions to industry standards.

We have connected internal technical and regulatory discussions that may not happen outside the BioPhorum collaboration, strengthening internal alignment in our member organizations.

We have touchpoints with members across the different phorums (including business development, phorum directors and account managers) for a clear communication path for the best regulatory alignment and support at all stages.

Regulatory support (REGx) deliverables

DeliverableDateDetailsDownload

Best regulatory practices for lifecycle management – registration of manufacturing controls

27 September, 2023
1,017.99 KB
415 downloads

Raw materials strategic framework and roundtable discussion

31 July, 2023Webinar

How the industry has adapted to changes in China CMC regulatory

27 July, 2023Webinar

Industry feedback on artificial intelligence in drug manufacturing FDA discussion paper

30 June, 2023
402.21 KB
389 downloads

BioPhorum feedback on ICH Q5A (R2)

29 March, 2023
386.00 KB
151 downloads

BioPhorum approach to the registration of innovative raw materials using quality by design principles – Appendix 2: Protein A resins

7 March, 2023
329.86 KB
333 downloads

BioPhorum feedback on ICH Q14 and Q2(R2)

26 September, 2022
250.21 KB
205 downloads

What is changing in China CMC regulatory?

10 June, 2022
7.51 MB
161 downloads

Webinar presentation PACMPS for LATAM

4 April, 2022
3.12 MB
807 downloads

Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version

21 February, 2022
223.94 KB
237 downloads

Industry feedback on USP bioreactivity draft monographs

31 January, 2022
182.87 KB
89 downloads

Industry feedback on the bacterial endotoxin test (BET)

27 January, 2022
158.96 KB
132 downloads

BioPhorum approach to the registration of innovative raw materials using quality by design (QbD) principles

18 January, 2022
1.65 MB
812 downloads

Industry proposal for a simplified registration process of complex and innovative raw materials in Europe

25 October, 2021
301.23 KB
167 downloads

Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

4 October, 2021
205.65 KB
208 downloads

Regulatory: Feedback to DMKA questions to critical GXP augmented intelligence

7 September, 2021
637.13 KB
139 downloads

An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics

3 September, 2021
240.56 KB
237 downloads

Industry proposal: Regulatory submission and lifecycle management strategy of models used in the manufacture of pharmaceutical and biological products

14 January, 2021
395.72 KB
472 downloads

Covid-19: Reference for COVID-19 viral control strategy in the biological manufacturing industry – industry position on the FDA guidance

23 October, 2020
1.01 MB
217 downloads

Russia: In-country analytical testing of biopharmaceuticals, general recommendations

3 March, 2020
259.41 KB
89 downloads

More related workstreams

Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.

Contact BioPhorum

To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.

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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
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Inaugural BioPhorum Quality face to face – get involved
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The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
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A launchpad for an improved CGT outbound supply chain
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A vision for the biopharmaceutical industry’s inbound supply chain
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Building a resilient business means adopting water stewardship
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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
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing